Law Concerning Medical Devices

Original Language Title: Gesetz über Medizinprodukte

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

Medical Devices Act (Medical Devices Act-MPG)

Non-official table of contents

MPG

Date of expend: 02.08.1994

Full quote:

" Medical Devices Act, as amended by the 7. August 2002 (BGBl. 3146), as provided for in Article 278 of the Regulation of 31 December 2008. August 2015 (BGBl. I p. 1474) "

:Recaught by Bek. v. 7.8.2002 I 3146;
last modified by Art. 16 G v. 21.7.2014 I 1133
Note:Modification by Art. 278 V v. 31.8.2015 I 1474 (No 35) not yet taken into

See the menu under Notes
This law is used to implement this law
-
Council Directive 90 /385/EEC of 20 years old. 1 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 327, 28. EC No 17), as last amended by Directive 93 /68/EEC (OJ L 197, 21.7.1993, p. EC No L 220 p. 1),
-
Council Directive 93 /42/EEC of 14 June 1992. June 1993 on medical devices (OJ L 196, 27.7.1993 EC No 1), as last amended by Directive 2001 /104/EC (OJ L 327, 31.12.2001, p. EC No 50) and
-
of Directive 98 /79/EC of the European Parliament and of the Council of 27. October 1998 on in vitro diagnostic medical devices (OJ L 327, 28.12.1998, p. EC No L 331 p. 1).

footnote

(+ + + text-proof from: 10.8.1994 + + +)
(+ + + Official notes of the norm-provider on EC law:
Implementation of the
EWGRL 385/90 (CELEX Nr: 31990L0385)
EWGRL 42/93 (CELEX Nr: 31993L0042)
EWGRL 68/93 (CELEX Nr: 31993L0068)
Implementation of the
EGRL 79/98 (CELEX Nr: 31998L0079)
EWGRL 385/90 (CELEX Nr: 31990L0385)
EWGRL 42/93 (CELEX Nr: 31993L0042) see Bek. v. 7.8.2002 I 3146
Implementation of
EGRL 47/2007 (CELEX Nr: 32007L0047) cf. G v. 29.7.2009 I 2326
Implementation of the
EGV 765/2008 (CELEX Nr: 32008R0765) see G v. 29.7.2009 I 2326 + + +)

unofficial table of contents

content overview

first section

purpose, scope of application Law,
§ 1Purpose of the law
§ 2Scope of the law
§ 3


Second Section

Medical device requirements and their operation
§ 4prohibitions to protect patients, users and third parties
§ 5The person responsible for the first placing on the market
§ 6 Requirements for placing on the market and putting into service
§ 7Basic Requirements
§ 8Harmonized Standards, Common Technical Specifications
§ 9 CE marking
§ 10Conditions for the initial placing on the market and the commissioning of systems and treatment units as well as for sterilization of medical devices
§ 11Special provisions for placing on the market and putting into service
§ 12Special products, medical devices made from in-house production, medical devices for clinical testing or for performance evaluation purposes, outposts
§ 13Medical device classification, delimitation to other products
§ 14 Set up, operate, apply and maintain medical


Third section

Named places and certificates
§ 15Designation and monitoring of the locations, recognition and commissioning of testing laboratories
§ 15a Designation and monitoring of conformity assessment bodies for third countries
§ 16Erasing, withdrawal, revocation and revocation of the Naming
§ 17Period of validity of the certificates of the notified bodies
§ 18 Restriction, suspension and withdrawal of certificates, teaching


Vated section

Clinical evaluation, performance assessment, clinical trial, Performance
§ 19Clinical Evaluation, Performance Evaluation
§ 20General requirements for clinical trial
§ 21Special requirements for clinical trial
§ 22Ethics Commission proceedings
§ 22a Approval procedure at the federal authority
§ 22bRevocation, revocation and revocation of the approval or the additional approval Rating
§ 22cChanges after approval of clinical trials
§ 23 Implementation of clinical trial
§ 23aReports on termination or termination of clinical trials
§ 23bClinical Check Exceptions
§ 24 Performance Evaluation


Fifth Section

Monitoring and Protection against Risks
§ 25 General Display obligation
§ 26Monitoring
§ 27Procedure in the case of unlawful and inadmissible affixing of the CE marking
§ 28Procedure for Protection against risks
§ 29Medical products-Observation and reporting system
§ 30 Security Officer for Medical Devices
§ 31Medical Product


Section

competent authorities, legal regulations, other provisions
§ 32Tasks and responsibilities the federal authorities in the medical device sector
§ 33Database-based information system, European database
§ 34Export
§ 35Fees and Offers
§ 36Authorities and notified bodies in the European Economic Area and the European Commission.
37Regulation authorisations
§ 37aGeneral administrative


Seventh section

Special rules for the Bundeswehr
§ 38Application and enforcement of the Law
§ 39


Achter section

Straf and BußMoney rules
§ 40Criminal rules
§ 41 Penal rules
§ 42BußMoney Rules
§ 43 confiscation


Neunter section

Transitional provisions
§ 44 Transitional provisions

First section
Purpose, scope of application of the law, definitions

Non-official table of contents

§ 1 Purpose of the law

The purpose of this law is to regulate the traffic with medical devices and thereby to ensure the safety, suitability and performance of the medical devices. Medical products and health and the necessary protection of patients, users and third parties. Non-official table of contents

§ 2 Scope of the law

(1) This law applies to medical devices and their accessories. Accessories are treated as an independent medical device.(2) This Act shall also apply to the application, operation and maintenance of products not placed on the market as medical devices, but with the purpose of a medical device within the meaning of Annexes 1 and 2 of Medical products-operator regulation are used. They are regarded as medical devices in the sense of this law.(3) This Act shall also apply to products intended to administer medicinal products within the meaning of Section 2 (1) of the Medicines Act. Where the medical devices referred to in the first sentence are placed on the market in such a way that the medical device and the medicinal product form a single product which is connected to each other and which is intended exclusively for use in this connection and which cannot be re-used , this Act shall apply only in so far as the medical device has to comply with the basic requirements laid down in § 7 concerning safety and performance-related product functions. In addition, the provisions of the Medicines Act shall apply.(4) The provisions of the Atomic Energy Act, the Radiation Protection Ordinance, the X-ray Ordinance and the Radiation Protection Act, the Chemicals Act, the Ordinance on Hazardous Substances, the Ordinance on Safety and Security, the Pressure Equipment Ordinance, the The aerosol packaging ordinance as well as the legislation on confidentiality and data protection shall remain unaffected.(4a) This Act shall also apply to products intended for use by the manufacturer, both for use in accordance with the provisions relating to personal protective equipment of Council Directive 89 /686/EEC of 21 June 1992 on the protection of the protection of personal protective equipment. 1 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 327, 28.12.1989 18), as well as Council Directive 93 /42/EEC of 14 June 1989 on the implementation of the European Economic and Economic Community (EC) No 93/491. June 1993 on medical devices (OJ L 196, 27.7.1993 OJ L 169, 12.7.1993, p. 1).(5) This law does not apply to
1.
Medicinal products within the meaning of Section 2 of the Medicines Act; the A decision as to whether a product is a medicinal product or a medical device shall be taken, in particular, taking into account the principal mode of action of the product, unless it is a medicinal product within the meaning of Article 2 (1). Point 2 (b) of the Medicines Act,
2.
Cosmetic Products as defined in Section 2 (5) of the Food, Commodities, Commodities and Commodities Act feed code,
3.
human blood, human blood products, human plasma or blood cells of human origin, or products at the time the placing on the market of blood products, plasma or cells of this type, unless they are medical devices in accordance with § 3 (3) or § 3 (4),
4.
Transplants or tissues or cells of human origin and products containing tissues or cells of human origin or obtained from such tissues or cells, in the case of medical devices not referred to in § 3 (4),
5.
transplants or tissues or cells of animal origin, unless a product is covered by The use of killed animal tissues or of killed products derived from animal tissues, or medical devices according to § 3 No. 4.
unofficial table of contents

§ 3 definitions

1.
Medical products are all individually or interlinked instruments, apparatus, devices, software, substances and preparations of substances or other objects including the software specifically intended for use by the manufacturer for diagnostic or therapeutic purposes and used for the proper functioning of the medical device, the software used by the manufacturer for use by the manufacturer its functions for the purpose
a)
for the detection, prevention, monitoring, treatment or alleviation of Diseases,
b)
Detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,
c)
the investigation, replacement, or change of anatomical or physiological process or
d)
of the contraception
to be used and their intended main effect in or on the human body neither by pharmacologically or immunologically acting It is still achieved by metabolism, but its mode of action can be supported by such means.
2.
Medical products are also products according to point 1, which contain or are applied to a substance or preparation of substances which, if used separately, may be regarded as a medicinal product within the meaning of Article 2 (1) of the Medicines Act and which are complementary to those of
3.
Medical products are also products according to point 1, which as part of a substance are used as a component of the product. , which is used separately as part of a medicinal product or medicinal product derived from human blood or plasma within the meaning of Article 1 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 June 2001, November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 28.12.2001, p. 67), as last amended by Regulation (EC) No 1394/2007 (OJ L 311, 28.11.2007, p. 121), which, in addition to the product, can have an effect on the human body.
4.
In-vitro diagnostic is a medical device that can be used as a reagent, reagent product, calibration material, control material, kit, instrument, apparatus, device or system, individually or in combination together with the purpose of the in vitro study of samples from the human body, including blood and tissue donations, as defined by the manufacturer, and which is used exclusively or mainly for the purpose of: Provide information
a)
about physiological or pathological states, or
b)
about innate anomalies or
c)
to check for safety or tolerability in the potential recipients or
d)
to monitor therapeutic measures.
Sample containers are considered as in vitro diagnostic agents. Sample containers shall be air-filled or other medical devices specially manufactured by their manufacturer to record samples originating from the human body immediately after they have been removed, and with a view to: To store in vitro studies. Products intended for general laboratory use shall not be considered as in vitro diagnostic medical devices unless they are to be used specifically for in vitro studies on the basis of their characteristics in accordance with the intended purpose defined by the manufacturer.
5.
In-vitro diagnostics for self-use is an in-vitro diagnostic agent that is used in the home environment according to the intended purpose of laypeople.
6.
New in the sense of this law is an in vitro diagnostic agent, if
a)
no such medical device for the corresponding analyte or other parameter during the previous three years within the European Economic Area not continuously Or
b)
the procedure is carried out using an analysis technique which does not exist within the European Economic Area during the preceding three years continue to be used in conjunction with a particular analyte or other parameter.
7.
As calibration and control material, substances are considered to be used. Materials and articles intended by their manufacturer to compare measurement data or to check the performance characteristics of an in vitro diagnostic test in relation to the intended use. Certified international reference materials and materials used for external quality evaluation programs are not in-vitro diagnostics within the meaning of this law.
8.
Special production is a medical device custom-made in accordance with the written regulation according to specific design characteristics and for exclusive use in the case of a designated patients. The mass-produced medical device, which has to be adapted to meet the specific requirements of the physician, dentist or other professional user, shall not be considered as a special item.
9.
Accessories for medical devices are articles, substances and preparations made of substances that are not themselves medical devices according to point 1 but are intended by the manufacturer to do so by to be used in a medical device to enable it to be used in accordance with the intended purpose of the medical device. Invasive medicinal products intended for the collection of samples from the human body for in vitro examination, as well as medical devices that come into direct contact with the human body for the purpose of sampling, shall not be considered as accessories for: In vitro diagnostic medical devices.
10.
Purpose is the use for which the medical device in the labelling, instructions for use or the advertising materials according to the Details of the group of persons referred to in point 15.
11.
Placing on the market is any supply of medical devices, whether in return for payment or free of charge to others. First placing on the market is the first delivery of new or newly prepared medical devices to others in the European Economic Area. The placing on the market under this law does not apply to
a)
the supply of medical devices for the purpose of clinical trial,
b)
delivery of in vitro diagnostics for performance assessment tests,
c)
the re-submission of a medical device after it has been put into service to others, unless it has been reprocessed or significantly changed.
A levy on It does not exist when medical devices are processed for another and returned to it.
12.
Start-up is the point at which the Medicinal product has been made available to the end user as a product which, for the first time, can be used in accordance with its intended purpose in the European Economic Area. In the case of active implantable medical devices, the delivery to the medical personnel for implantation is deemed to be put into service.
13.
The placement or the placement of the implantable medical device is the result of the application Presentation of medical devices for the purpose of advertising.
14.
The preparation of medicinal products intended for use in accordance with germarm or steril is the following: cleaning, disinfection and sterilisation carried out for the purposes of re-application, including the related work steps, as well as the testing and restoration of the technical-functional Safety.
15.
Manufacturer is the natural or legal person who is responsible for the design, manufacture, packaging and labelling of a medical device in view of is responsible for the first placing on the market on its own behalf, whether these activities are carried out by that person or by a third person on behalf of the person concerned. The obligations imposed on the manufacturer under this Act shall also apply to the natural or legal person who assembles, unpacks, treats, processes, characterizes or defines one or more pre-fabricated medical devices the intended use as a medical device is responsible for the first placing on the market in its own name. This shall not apply to natural or legal persons who-without being a producer within the meaning of sentence 1-assemble medical devices already placed on the market for a named patient in accordance with their intended purpose, or
16.
The authorized representative is the natural or legal person established in the European Economic Area, which is expressly designated by the manufacturer to act on its behalf in view of its obligations under this Act and to be available to the authorities and competent authorities.
17.
Specials are members of the medical profession, medical or healthcare facilities, and other persons, as far as they manufacture medical devices, inspect, place on the market in the course of their profession, implant, operate in operation
18.
Harmonized standards are such standards of States Parties to the Agreement on the European Economic Area, which meet the standards of , the references of which have been published in the Official Journal of the European Union as a "harmonised standard" for medical devices. The findings of the relevant standards are published by the Federal Institute for Drugs and Medical Devices in the Federal Gazette (Bundesanzeiger). The standards referred to in sentences 1 and 2 are monographs of the European Pharmacopoeia relating to medical devices, the references of which are published in the Official Journal of the European Union and are published as monographs of the European Pharmacopoeia, official German edition, published in the German Federal Gazette.
19.
Common technical specifications are such specifications, the in-vitro diagnostic medical devices pursuant to lists A and B of Annex II to Directive 98 /79/EC of the European Parliament and of the Council of 27 June 1999, October 1998 on in vitro diagnostic medical devices (OJ L 327, 28.12.1998, p. EC No 1), as amended, and whose references have been published in the Official Journal of the European Union and published in the Federal Gazette (Bundesanzeiger). These specifications shall set criteria for the evaluation and reassessment of the performance, batch release criteria, reference methods and reference materials.
20.
Named body is one for conducting tests and issuing certificates in connection with conformity assessment procedures in accordance with the legal regulation according to § Article 37 (1), designated by the European Commission and the States Parties to the Agreement on the European Economic Area, by a State Party to the Agreement on the European Economic Area.
21.
Medical devices from their own production are medical devices including accessories that are manufactured and applied in a health facility without placing them in the market or in accordance with the requirements of a special production in accordance with point 8.
22.
In vitro diagnostic medical devices are in-vitro diagnostics, which are available in laboratories are manufactured by health facilities and are used in these laboratories or in rooms in close proximity to them, without being placed on the market. For in vitro diagnostic devices manufactured on an industrial scale, the rules on self-production are not applicable. Sentences 1 and 2 shall apply mutaly to in vitro diagnostic medical devices manufactured in blood establishments which are used for the examination of blood preparations, provided that they are authorised in the context of the authorisation of the medicinal product by the competent authorities to the examination of the blood. the federal authority.
23.
Sponsor is a natural or legal person who is responsible for the instigation, organization and financing of a clinical trial in humans or a performance assessment test of in vitro diagnostic medical devices.
24.
Reviewer is usually a member responsible for the implementation of the clinical examination in the case of humans in a laboratory responsible for the treatment of human beings, or in justified exceptional cases, another person whose profession, due to his scientific requirements and his experience in the exercise of his/her duties, is in the Patient care is qualified to carry out research on the human being. If a test is carried out in a test site by a number of examiners, the head of the group of principal examiners shall be the responsible manager. If a test is carried out in a number of test sites, the sponsor shall appoint an auditor as the head of the clinical trial. The rates 1 to 3 shall apply to performance assessment tests of in vitro diagnostic medical devices subject to approval.
25.
Clinical data are security or safety data. Benefits that result from the use of a medical device. Clinical data comes from the following sources:
a)
a clinical trial of the relevant Medicinal product or
b)
Clinical trials or other studies in the scientific literature on a similar product, (c
published or unpublished reports on other clinical trials, including the following: Experience either with the medical device concerned or with a similar product, the similarity of which can be demonstrated with the medical device concerned
26.
Importer within the meaning of this law is any natural or legal person established in the European Union who is a medical device from a third country in the European Union in traffic.

Second section
Requirements for medical devices and their operation

unofficial table of contents

§ 4 prohibitions on the protection of patients, users and third parties

(1) It is prohibited to place medical devices on the market, to install, to operate, to operate or apply when
1.
is suspected of having the security and the Health of patients, users or third parties in the case of appropriate use, maintenance and their intended use of appropriate use beyond a measure acceptable according to the findings of the medical sciences, directly or indirectly endanger, or
2.
the date has expired, until it is verifiably possible to use a safe application.
(2) It is also prohibited to to place medical devices on the market if they are provided with a misleading description, indication or presentation. In particular, misguidance occurs when
1.
Medical Devices is provided with a performance that is they do not have,
2.
wrongly the impression is raised that a success can be expected with certainty or that after intended or longer use no harmful effects occur,
3.
appropriate names for the deception of the product characteristics as defined in the basic requirements of § 7, Any information or arrangements that may be used for the evaluation of the medical device.
Non-official contents of the table of contents

§ 5 Responsible for the initial placing on the market

Responsible for the first placing on the market of medical devices is the manufacturer or his authorised representative. If medical devices are not introduced into the European Economic Area under the responsibility of the authorised representative, the importer shall be responsible. The name or company name and address of the person responsible shall be included in the labelling or instructions for use of the medical device. Non-official table of contents

§ 6 Prerequisites for placing on the market and putting into service

(1) Medical products, except for Special products, medical devices from own production, medical devices according to § 11 para. 1 as well as medical devices which are intended for clinical testing or in-vitro diagnostics intended for performance evaluation purposes may only be used in Germany. Transport shall be carried out or put into service if it is accompanied by a CE marking in accordance with the first sentence of paragraph 2 and the first sentence of paragraph 3. Provisions beyond the requirements of the procurement which relate to the operation or the application of medical devices shall remain unaffected.(2) Medical devices may only be labelled with the CE marking if the basic requirements of § 7, which are applicable to them in the light of their intended purpose, are met and a medical device for the relevant medical device is fulfilled. The prescribed conformity assessment procedure has been carried out in accordance with the provisions of Section 37 (1) of the German Law. Intermediate products, which are specifically designated by the manufacturer as a component for custom-made products, may be marked with the CE marking if the conditions set out in the first sentence are met. If the manufacturer is not established in the European Economic Area, the medical device may, in addition to the first sentence, be marked with the CE marking only if the manufacturer is responsible for a single medical device. Authorised representative in the European Economic Area.(3) If the medical device is in addition to other legislation other than that which is confirmed by the CE marking, the manufacturer may only provide the medical device with the CE marking, if: these other pieces of legislation have been complied with. If, on the basis of one or more other legislation, the manufacturer is free to choose the applicable rules during a transitional period, he shall indicate, by means of the CE marking, that this medicinal product shall be applied only to the Legislation. In this case, the manufacturer shall indicate in the documents, instructions or instructions accompanying the medical device the numbers of the directives adopted by the legislation in question, under which they shall be published in the Official Journal of the European Union be published. In the case of sterile medical devices, these documents, instructions or instructions must be accessible without destroying the packaging, by means of which the sterility of the medical device is guaranteed.(4) The implementation of conformity assessment procedures shall be without prejudice to the civil and criminal responsibility of the person responsible in accordance with § 5. Non-official table of contents

§ 7 Basic Requirements

(1) The basic requirements are for active implantable medical devices. Requirements set out in Annex 1 to Council Directive 90 /385/EEC of 20 June 2000. 1 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 327, 28. 17), which was last amended by Article 1 of Directive 2007 /47/EC (OJ L 189, 20.7.2007, p. 21), the requirements set out in Annex I to Directive 98 /79/EC for in vitro diagnostic medical devices and the requirements of Annex I to Council Directive 93 /42/EEC of 14 December 2007 for the other medical devices are amended. June 1993 on medical devices (OJ L 196, 27.7.1993 1), as last amended by Article 2 of Directive 2007 /47/EC (OJ L 378, 27.12.2007, p. 21) has been amended, in the relevant versions.(2) If there is a relevant risk, medical devices which also include machinery within the meaning of Article 2 (a) of Directive 2006 /42/EC of the European Parliament and of the Council of 17 May 2006, 1 May 2006 on machinery (OJ L 327, 28. 24) also comply with the essential health and safety requirements laid down in Annex I to that Directive, provided that these basic health and safety requirements are more specific than those laid down in Annex I to the Directive. Basic requirements set out in Annex I to Directive 93 /42/EEC or in accordance with Annex 1 to Directive 90 /385/EEC.(3) In the case of products intended for use by the manufacturer not only as a medical device but also for use in accordance with the provisions relating to personal protective equipment of Directive 89 /686/EEC, the relevant basic products must also be: Health and safety requirements of this Directive are met. Non-official table of contents

§ 8 Harmonized standards, common technical specifications

(1) voices medical devices with harmonized standards or monographs of the European Pharmacopoeia or Common Technical Specifications relating to the medical device concerned shall be presumed to comply with the provisions of this Act.(2) The common technical specifications shall be complied with as a general rule. If, in duly substantiated cases, the manufacturer does not meet these specifications, he/she shall choose solutions which are at least equivalent to the level of the specifications. Non-official table of contents

§ 9 CE Marking

(1) The CE marking is for active implantable medical devices in accordance with Annex 9 of the Directive 90 /385/EEC, in the case of in vitro diagnostic medical devices referred to in Annex X to Directive 98 /79/EC and for other medical devices referred to in Annex XII to Directive 93 /42/EEC. Signs or inscriptions likely to mislead third parties with regard to the meaning or graphic design of the CE marking must not be affixed. All other signs may be affixed to the medical device, the packaging or the instructions for use of the medical device, provided that they do not impair the visibility, legibility and meaning of the CE marking.(2) The CE marking must be affixed by the person designated for this purpose in the provisions relating to conformity assessment procedures in accordance with the provisions of Section 37 (1) of the Regulation.(3) The CE marking referred to in the first sentence of paragraph 1 shall be clearly visible, legible and permanently affixed to the medical device and, if present, to the trade pack and to the instructions for use. The CE marking must not be affixed to the medical device if it is too small, its nature does not allow it, or it is not appropriate. The CE marking must be added to the identification number of the notified body responsible for carrying out the conformity assessment procedure laid down in Annexes 2, 4 and 5 to Directive 90 /385/EEC, Annexes II, IV, V and VI to Directive 93 /42/EEC and to Annexes III, IV, VI and VII to Directive 98 /79/EC, which has led to the authorisation to affix the CE marking. In the case of medical devices which have to bear the CE marking and are placed on the market in a sterile condition, the CE marking must be affixed to the sterile packaging and, where appropriate, to the trade pack. Where a medical device requires a conformity assessment procedure which does not have to be carried out by a notified body, the CE marking must not be added to a designation number of a notified body. Non-official table of contents

§ 10 Prerequisites for the initial placing on the market and the putting into service of systems and treatment units as well as for the sterilisation of medical devices

(1) medical devices which carry a CE marking and which, in accordance with their intended purpose, are assembled within the limits of application provided by the manufacturer, in the form of a To be placed on the market for the first time in a system or a treatment unit, no conformity assessment procedures shall be applied. If you are responsible for the composition of the system or the treatment unit, you must make a statement in this case in accordance with the legal regulation pursuant to § 37 (1).(2) The system or the treatment unit shall contain medical devices or other products which do not bear the CE marking in accordance with this Act, or the chosen combination of medical devices shall not be the same as their original The system or the treatment unit must be subject to a conformity assessment procedure in accordance with the provisions of Article 37 (1) of the Law.(3) Any system or treatment unit referred to in paragraph 1 or 2 or any other medical device bearing a CE marking, for which the manufacturer has provided for sterilisation prior to use, shall be sterilised for the first placing on the market; shall carry out a conformity assessment procedure and make a statement in accordance with the provisions of Article 37 (1) of this Regulation. This shall apply if medical devices which are used in a sterile manner are prepared after the first placing on the market and are delivered to others.(4) Medical devices, systems and treatment units referred to in paragraphs 1 and 3 shall not be marked with an additional CE marking. Those who make up or sterilize systems or units of treatment referred to in paragraph 1 and sterilize medical devices referred to in paragraph 3 shall, in accordance with paragraph 7, have the medical device referred to in points 11 to 15 of Annex 1 to Directive 90 /385/EEC, in accordance with Points 13.1, 13.3, 13.4 and 13.6 of Annex I to Directive 93 /42/EEC or points 8.1, 8.3 to 8.5 and 8.7 of Annex I to Directive 98 /79/EC shall be accompanied by the information required by the manufacturer of the products referred to in that Directive: The system or the treatment unit has to be included in the instructions provided. Non-official table of contents

§ 11 Special provisions for placing on the market and putting into service

(1) By way of derogation from the provisions of section 6 (1) and 2, the competent federal authority may, on a reasoned request, first place the medicinal product on the market or put into service individual medical devices in respect of which the proceedings have not been carried out in accordance with the provisions of Article 37 (1) in accordance with the provisions of the legal regulation, in Allow Germany to apply for a limited period if its application is in the interests of health protection. The authorisation may be extended on a duly substantiated request.(2) Medical devices may only be delivered to the user if the information intended for him is written in German. In justified cases, another language which is easy to understand for the user of the medical device can be provided, or the information of the user can be guaranteed by other measures. However, the security-related information must be available in the German language or in the language of the user.(3) Rules relating to the prescription of medical devices may be made by means of a legal regulation pursuant to Section 37 (2), regulations on the distribution channels of medical devices by means of a legal regulation pursuant to § 37 (3).(3a) In vitro diagnostics for the detection of HIV infections may only be given to
1.
Doctors,
2.
outpatient and inpatient healthcare facilities, wholesalers and pharmacies,
3.
Health authorities of the federal, state, local and community associations
.(4) By means of a legal regulation in accordance with Section 37 (4), regulations may be issued for establishments and facilities that place or store medical devices in Germany. Non-official table of contents

§ 12 Special orders, medical devices from own production, medical devices for clinical trial, or for

(1) Special orders may be placed on the market or put into service only if the basic requirements of Section 7 applicable to them, taking into account their intended purpose, apply to them , and the conformity assessment procedure provided for them has been carried out in accordance with the provisions of Article 37 (1) of the Regulation. The responsible person in accordance with § 5 shall be obliged to submit to the competent authority, on request, a list of the special orders. The provisions of sentence 1 shall apply to the putting into service of medical devices from the production of their own in accordance with § 3 (21) and (22).(2) Medical devices intended for clinical examination may be submitted to doctors, dentists or other persons authorised to carry out such tests on the basis of their professional qualifications, only if: active implantable medical devices meet the requirements of point 3.2, first and second sentences of Annex 6 to Directive 90 /385/EEC, and in the case of other medical devices, the requirements of point 3.2 of Annex VIII to Directive 93 /42/EEC. The sponsor of the clinical trial shall at least 15 years and the documentation referred to in point 3.2 of Annex VIII to Directive 93 /42/EEC, at least five years and in the case of shall keep implantable products at least 15 years after the end of the test.(3) In-vitro diagnostics for performance assessment tests may, for this purpose, be submitted to doctors, dentists or other persons empowered to carry out such tests on the basis of their professional qualifications only if the The requirements of point 3 of Annex VIII to Directive 98 /79/EC are met. The sponsor of the performance assessment test shall keep the documentation referred to in point 3 of Annex VIII to Directive 98 /79/EC at least five years after the end of the examination.(4) Medical products which do not meet the requirements of § 6 (1) and (2) or § 10 may only be issued if a visible sign clearly indicates that they do not meet the requirements and are only acquired if the match is established. In the case of presentations, the necessary precautions must be taken to protect persons. In vitro diagnostic medical devices issued in accordance with the first sentence may not be applied to samples taken by a visitor to the exhibition. Non-official table of contents

§ 13 Classification of medical devices, delimitation to other products

(1) Medical products except for the In vitro diagnostics and the active implantable medical devices are assigned to classes. Classification shall be carried out in accordance with the classification rules laid down in Annex IX to Directive 93 /42/EEC.(2) In the event of disagreement between the manufacturer and a notified body on the application of the above rules, the notified body of the competent federal authority shall submit the matter to the competent authority for a decision.(3) The competent federal authority shall also decide, at the request of a competent authority or of the manufacturer, on the classification of individual medical devices or on the delimitation of medical devices to other products.(4) The competent authority shall forward all decisions concerning the classification of medical devices and the delimitation of medical devices to other products to the German Institute for Medical Documentation and Information on the Central Processing and use according to § 33 (1) sentence 1. This shall apply in accordance with decisions taken by the competent authority of the Federal Government in accordance with paragraphs 2 and 3. Non-official table of contents

§ 14 Reeration, operation, application and maintenance of medical devices

Medical devices may only be used in accordance with the Ordinance pursuant to Section 37 (5) of this Regulation shall be established, operated, applied and kept in stand. They must not be operated and applied if they have defects that may endanger patients, employees or third parties.

Third section
Named posts and certificates

unofficial table of contents

§ 15 Naming and monitoring of bodies, recognition and appointment of test laboratories

(1) Federal Ministry of Health shall inform the Federal Ministry of Economics and Technology of the tasks of the competent authority for the performance of tasks related to conformity assessment in accordance with the provisions of Article 37 (1) of the Law , notified bodies and their areas of responsibility, which shall be forwarded by the latter to the European Commission and to the other States Parties to the Agreement on the European Economic Area. A request for designation may be submitted to the competent authority as a notified body. The nomination shall be subject to the qualification of the body responsible for carrying out its tasks and compliance with the criteria set out in Annex 8 to Directive 90 /385/EEC, Annex XI to Directive 93 /42/EEC or Annex IX to the Directive. 98 /79/EC, in accordance with the procedures for which it is to be designated, by the competent authority in a designation procedure. The bodies which meet the criteria laid down in the national standards adopted for the implementation of the relevant harmonised standards shall be adopted in accordance with the relevant criteria. The designation may be granted subject to conditions and may be limited to a limited period. The Federal Ministry of Health shall immediately notify the Federal Ministry of Health of the appointment, expiry, withdrawal, revocation and erasure of the designation.2. The competent authority shall monitor compliance with the obligations and requirements set out in paragraph 1 for notified bodies. It shall take the necessary measures to remedy the shortcomings identified or to prevent future infringements. The monitoring of the notified bodies involved in the implementation of conformity assessment procedures for medical devices which produce ionizing radiation or containing radioactive substances shall be carried out on behalf of the Federal Republic of Germany by the Countries running. The competent authority may require the notified body and its staff responsible for managing and carrying out technical tasks to provide the necessary information and other assistance in order to carry out its monitoring tasks; it shall: authorized to accompany the notified body in the event of verifications. Their representatives shall be authorised to enter and inspect land and business premises, as well as test laboratories, at the operating and business hours, and shall submit documents, in particular on the issuing of certificates and proof of proof of their use. the fulfilment of the requirements of the second sentence of paragraph 1. The right of access also extends to the base of the manufacturer, as far as the monitoring takes place there. Section 26 (4) and (5) shall apply accordingly.(3) The bodies set up by the European Commission and the other Member States of the European Union by a State Party to the Agreement on the European Economic Area under the terms of a Council act or the European Commission , the notified bodies referred to in paragraph 1 shall be treated as equivalent.(4) The German notified bodies shall be made known by the competent authority on their website with their respective tasks and their identification number.(5) Where a notified body is responsible for carrying out its duties, it shall ensure that these laboratories comply with the criteria set out in Annex 8 to Directive 90 /385/EEC, Annex XI to Directive 93 /42/EEC or Annex IX to the Directive 98 /79/EC in accordance with the procedures for which they are to be mandated. The fulfilment of the minimum criteria shall be established by the competent authority in a recognition procedure. Non-official table of contents

§ 15a Appointment and monitoring of conformity assessment bodies for third countries

(1) Conformity assessment body for third countries is a natural or legal person or a legally competent civil society empowered to carry out conformity assessment tasks in the field of medical devices for the third country or third countries referred to in To carry out the framework of the respective agreement of the European Community or of the European Union with third States or organisations in accordance with Article 216 of the Treaty on the Functioning of the European Union. Section 15 (1) and (2) shall apply accordingly.(2) The designation as a conformity assessment body for third countries shall be based on a designation procedure, carried out by the competent authority, which shall be used to empower the body to carry out its tasks in accordance with the relevant sectoral sectoral rules. The requirements of the respective agreements are established.(3) The designation as a conformity assessment body for third countries may be granted subject to conditions and may be limited to a limited period. The issuing, expiry, withdrawal, revocation and expiry of the designation shall be notified immediately to the Federal Ministry of Health and to the institutions mentioned in the respective agreements. Unofficial table of contents

§ 16 Erdeleting, revocation, revocation and revocation of the name

(1) The designation is extinguished by means of the expiry date, with the Adjustment of the operation of the notified body or by renunciation. The competent authority shall immediately inform the competent authority of the suspension or renunciation.(2) The competent authority shall withdraw the designation to the extent that it is subsequently known that a notified body has not fulfilled the conditions for a designation in the case of the appointment; it shall revoke the appointment, in so far as the conditions for a nomination for a designation of Nominations have subsequently been omitted. In place of the revocation, the call may be ordered.(3) In the cases referred to in paragraphs 1 and 2, the former notified body shall be obliged to provide all relevant information and documents of the notified body with which the manufacturer must continue the conformity assessment procedures. agreed.(4) The competent authority shall forthwith inform the Federal Ministry of Health and the other competent authorities in Germany of the erasure, withdrawal and revocation, stating the reasons and the measures deemed necessary. The Federal Ministry of Health shall immediately inform the Federal Ministry of Economics and Technology, which shall immediately inform the European Commission and the other Contracting States of the Agreement on the European Economic Area is informed. Erasing, withdrawal and revocation of a designation shall be made known by the competent authority on its website.(5) Paragraphs 1, 2 and 4 shall apply in accordance with conformity assessment bodies for third countries. Non-official table of contents

§ 17 Duration of certificates of the notified bodies.

(1) Insofar as they are appointed by a notified body within the framework of a The application of conformity assessment procedures in accordance with the provisions of Article 37 (1) of the Regulation has a limited period of validity, the period of validity may be extended on application by a maximum of five years. Should this notified body no longer exist or if other reasons require the change of the notified body, the application may be made to another notified body.(2) A report containing information on whether and to what extent the assessment characteristics for conformity assessment have been amended since the issue or extension of the certificate of conformity, shall be submitted with the request for renewal. . Unless otherwise agreed with the notified body, the application shall be submitted no later than six months before the expiry of the period of validity. Non-official table of contents

§ 18 Restriction, suspension and withdrawal of certificates, teaching duties

(1) Presents a user Where it is established that the conditions for issuing a certificate from the manufacturer are not or are no longer fulfilled, or that the certificate should not have been issued, it shall restrict it, taking into account the principle of In the event of a proportionality, the certificate issued, shall suspend or withdraw the certificate, unless the person responsible shall ensure compliance with the conditions by means of appropriate remedial measures. The notified body shall take the necessary measures without delay.(2) Before deciding on a measure referred to in paragraph 1, the manufacturer shall be consulted by the notified body, unless such a hearing is not possible in view of the urgency of the decision to be taken.(3) The notified body shall inform
1.
without delay the German Institute for Medical Documentation and information on all issued, amended, amended and, with indication of the reasons, on all rejected, restricted, withdrawn, suspended and re-established certificates; § 25 (5) and (6) applies as appropriate,
2.
immediately the competent authority of the competent authority in cases where the intervention of the competent authority proves necessary ,
3.
on request, the other notified bodies or the competent authorities on their certificates and shall provide additional information to the extent necessary to:
4.
On request, third parties are provided with information in certificates issued, modified, supplemented, suspended or revoked.
(4) The German Institute In the case of medical documentation and information, the competent authority responsible for the responsible person in accordance with Section 5 shall electronically inform the competent authority of restricted, refused, suspended, re-established and withdrawn certificates. The Federal Government, the European Commission, the other States Parties to the Agreement on the European Economic Area, and shall grant the notified bodies an access to this information.

Fourth
Clinical Evaluation, Performance Evaluation, Clinical Review, Performance Evaluation Review

Non-Official Table of Contents

§ 19 Clinical evaluation, performance evaluation

(1) The suitability of medical devices for the intended use is to be demonstrated by a clinical evaluation based on clinical data in accordance with § 3, point 25, unless justified in substantiated form. Exceptions to other data are sufficient. The clinical evaluation shall include the assessment of adverse effects as well as the acceptability of the benefit/risk ratio as referred to in the basic requirements of Directives 90 /385/EEC and 93 /42/EEC. The clinical evaluation shall be carried out in accordance with a defined and methodically sound procedure and shall, where appropriate, take into account relevant harmonized standards.(2) The suitability of in vitro diagnostic agents for the intended use shall be demonstrated by a performance assessment on the basis of appropriate data. The performance rating is to be supported on
1.
Data from the scientific literature, which is the the application of the medical device and the techniques used in the process, as well as a written report containing a critical assessment of the data, or
2.
the results of all performance assessment tests or other appropriate checks.
Non-official table of contents

§ 20 General requirements for clinical trial

(1) The clinical examination of a medical device may only begin in Germany if the clinical trial of a medical device is not possible. The competent Ethics Committee assesses them in accordance with § 22 and has approved the competent authority in accordance with § 22a. In the case of clinical trials of medical devices with a low safety risk, the competent authority of the Federal Republic of Germany may depart from a permit. The details of this procedure are laid down in a legal regulation in accordance with § 37 (2a). The clinical examination of a medical device may only be performed in humans, if and as long as
1.
The risks associated with it for the person at which it is to be carried out, as measured by the probable significance of the medical device for the medical certificate
1a.
is a sponsor or a representative of the sponsor who is based in one of the Member States of the European Union or in another Member State. State Party of the Agreement on the European Economic Area,
2.
the person in which it is to be carried out has given his consent to the Agreement after: It has been informed by a doctor, in the case of medical devices intended for dentistry, also by a dentist, about the nature, significance and scope of the clinical trial and, with this consent, at the same time, declares that it has been used in the Clinical examination framework for the recording of health data and acceptance for examination purposes by the commissioner or the competent authority,
3.
The person to be performed on is not held in a court or government order in an institution,
4.
carried out in a suitable facility and by a suitably qualified examiner, and by a suitably qualified and specialized doctor, for the Dentistry is also led by a dentist, or any other suitably qualified and authorized person who has at least a two-year experience in the clinical testing of medical devices. ,
5.
where necessary, a biological safety check corresponding to the state of the scientific findings, or any other biological safety assessment for the ,
6.
as far as necessary, the safety safety of the medical device for the purpose of the medical device, the safety and safety of the medical device, the safety and the safety of the medical device Application of the medical device, taking into account the state of the art as well as the occupational safety and accident prevention regulations,
7.
the examiners have been informed of the results of the biological safety assessment and the testing of the safety and the risks associated with the clinical trials,
8.
a test plan corresponding to the state of the scientific findings, and
9.
in case a person is killed or the body or the health of a person is injured or compromised during the conduct of the clinical trial, insurance in accordance with the provisions of paragraph 3, which shall also provide benefits if no other person is liable for the damage.
(2) The consent referred to in paragraph 1 (2) shall be effective only if the person who gives it is
1.
Capable and capable of being, nature, risks, meaning, and scope of clinical trial and to determine their will hereafter, and
2.
has given the consent itself and in writing.
A consent can be revoked at any time.(3) The insurance referred to in paragraph 1 (9) shall be taken in favour of the person concerned by the clinical trial in the case of a insurer authorised to operate in Germany. Its scope shall be proportionate to the risks associated with the clinical trial and shall be determined on the basis of the risk assessment in such a way as to ensure that, in any event, the death or invalidity of the invalidity of any of the risks arising from the clinical trial must be assessed in such a way as to be proportionate the person concerned is at least 500 000 euro available to the clinical trial. As far as the insurance is provided, a claim for damages shall be issued.(4) In the case of a clinical trial in the case of minors, paragraphs 1 to 3 shall apply with the following conditions:
1.
The medical device must be designed to detect or prevent disease among minors.
2.
The application of the medical device must be indicated according to the findings of medical science in order to identify diseases in the minor or to prevent them from diseases.
3.
The clinical trial in adults must not expect sufficient test results according to the findings of medical science
4.
The consent is given by the legal representative or caregiver. It is effective only if the latter has been informed by a doctor, in the case of medical devices intended for dentistry, also by a dentist, on the nature, significance and scope of the clinical trial. If the minor is able to see the nature, significance and scope of the clinical trial and to determine his will, his/her written consent is also required.
(5) A clinical trial in pregnant women or breast-feeding, paragraphs 1 to 4 shall apply, subject to the following conditions: clinical trial may only be performed if
1.
the medical device is intended to prevent, detect, heal or to cure in pregnant or breast-feeding women or in an unborn child 2.
2.
the application of the medical device according to the findings of medical science is indicated to the pregnant or breastfeeding woman or to detect diseases or their course, cure or alleviate diseases, or to protect the pregnant or breast-feeding woman or the unborn child from disease,
3.
According to medical science findings, the conduct of the clinical trial for the unborn child does not expect any unrealistic risks and
4.
The clinical examination according to the findings of medical science can only be expected if it is available to pregnant or breast-feeding women.
(6) (omitted) (7) (omitted) (8) (omitted) Non-official table of contents

§ 21 Special requirements for clinical Examination

§ 20 (1) to (3) shall apply to a clinical trial in the case of a person suffering from a disease to which the medical device to be tested is to be applied, subject to the following conditions: style="font-weight:normal; font-style:normal; text-decoration:none; ">
1.
The clinical trial may only be performed if the application of the medical device to be tested is according to the findings of medical science, to save the life of the sick, to restore his health or to facilitate his suffering.
2.
The clinical trial may also be carried out with a person who is incapacitated or limited in business capacity. They shall require the consent of the legal representative. In addition, it also requires the consent of the representative if he is able to see the nature, significance and scope of the clinical trial and to determine his will.
3.
The consent of the legal representative is only effective if this by a doctor, with medical devices intended for dentistry, also by a dentist, by nature, The importance and scope of the clinical trial has been elucted. Section 20 (2) sentence 2 shall apply to the revocation. The consent of the legal representative shall not be required for as long as a treatment without delay is necessary in order to save the life of the patient, to restore his or her health or to facilitate his suffering, and to make a statement on the
of the patient or of the legal representative is also effective if it is oral to the person who is responsible for the In the case of medical devices intended for dentistry, the doctor treating the dentist is also given a witness in the presence of a witness, who was also involved in the information of the person concerned. The witness shall not be a person employed by the test office and not a member of the test group. Oral consent is to be documented, dated and signed by the witness. Non-official Table of contents

§ 22 Procedure with the Ethics Committee

(1) The evaluation of the Ethics Committee required pursuant to § 20 (1) sentence 1 shall be independent of the sponsor in the case of the independent independent auditor responsible for the auditor under the national law. To apply for an interdisciplinary Ethics Committee. If the clinical trial is carried out by a number of examiners, the application shall be submitted to the independent Ethics Committee responsible for the principal auditor or head of the clinical trial. In the case of multicentre clinical trials, a vote is sufficient. The information on the education, composition and funding of the Ethics Committee is determined by national law. The sponsor shall submit to the Ethics Committee all the particulars and documents required for evaluation. In order to evaluate the documents, the Ethics Committee may use its own scientific findings, provide expert advice or request expert opinions. It shall consult experts or request expert opinions if it is a clinical trial in the case of minors and does not have their own expertise in the field of paediatrics, including ethical and psychosocial Questions of paediatrics. The details of the procedure will be laid down in a legal regulation pursuant to § 37 (2a).(2) The Ethics Committee has the task of advising and examining the test plan and the necessary documents, in particular according to ethical and legal aspects, whether the conditions set out in Article 20 (1) sentence 4 (1) to (4) and (7) to (9) are met. , as well as paragraphs 4 and 5 and in accordance with § 21.(3) The additional evaluation may only be denied if
1.
the submitted documents also after expiration a reasonable time limit set by the sponsor is incomplete,
2.
the documents submitted, including the audit plan, the audit information and the Modalities for the selection of subjects shall not be in accordance with the state of scientific knowledge, and in particular the clinical trial shall be unsuitable for providing evidence of the safety, performance or effect of the medical device; or
3.
which is not satisfied in § 20 (1) sentence 4 (1) to (4) and (7) to (9), as well as (4) and (5), and the requirements referred to in § 21.
(4) The Ethics Committee shall forward a decision on the application referred to in paragraph 1 within 60 days of receipt of the necessary documents. It shall also inform the competent federal authority of the decision. Non-official table of contents

§ 22a Approval procedure for the federal authority

(1) The required approval pursuant to Section 20 (1) sentence 1 is from the Apply for sponsor to the competent federal authority. The application must, with the exception of the opinion of the Ethics Committee concerned, in the case of active implantable medical devices, the information referred to in point 2.2 of Annex 6 to Directive 90 /385/EEC and, in the case of other medical devices, the information referred to in Point 2.2 of Annex VIII to Directive 93 /42/EEC. In addition, the sponsor has to submit all the information and documents required by the competent federal authority for evaluation. The opinion of the Ethics Committee is to be followed up. The details of the procedure will be laid down in a legal regulation pursuant to § 37 (2a).(2) The competent federal authority shall have the task of examining the test plan and the necessary documents, in particular according to scientific and technical aspects, whether the conditions set out in Article 20 (1) sentence 4 (1), (5), (6) and (8) will be met.(3) The authorisation may only be denied if
1.
the submitted documents also after the expiry of a The appropriate deadline for supplementing it is incomplete,
2.
the medical device or the submitted documents, in particular the information on the test plan. , including the test information, not in accordance with the state of scientific knowledge, in particular the clinical trial is not appropriate to provide evidence of the safety, performance or effect of the medical device, or
3.
the requirements specified in § 20 (1) sentence 4 (1), (5), (6) and (8) are not fulfilled.
(4) The approval shall be deemed to have been granted if the competent authority Federal authority shall not transmit any reasoned objection to the sponsor within 30 days of receipt of the application documents. If the sponsor has not amended the application for a reasoned objection within a period of 90 days, the application shall be deemed to have been rejected.(5) Following a decision of the competent federal authority on the application for authorisation or after the expiry of the period referred to in the second sentence of paragraph 4, the submission of documents relating to the removal of defects shall be excluded.(6) The competent federal authority shall inform the competent authorities of approved and rejected clinical trials and evaluations carried out by the Ethics Committee and shall inform the competent authorities of the other Contracting States of the European Union Economic Area and the European Commission on rejected clinical trials. Information is automatically provided via the information system of the German Institute for Medical Documentation and Information. Section 25 (5) and (6) shall apply accordingly.(7) The competent ethics committee for the approval of a clinical trial shall inform the competent Ethics Committee, provided that it has received information on other clinical trials, which are available for the evaluation of the ethics committee of the Ethics Committee. shall be subject to peer review, in particular for information on aborted or prematurely completed exams. The transfer of personal data shall not be subject to the provisions of this Directive, and business and business secrets shall also be respected. The second and third sentences of paragraph 6 shall apply accordingly. Unofficial table of contents

§ 22b Revocation, revocation and revocation of the approval or approval rating

(1) The approval according to § 22a is , if it is known that a reason for the failure to grant has been provided for in accordance with Section 22a (3). It shall be revoked if facts subsequently arise which would justify the failure to act in accordance with Section 22a (3) (2) or (3). In the cases of sentence 1, the rest of the permit may also be arranged for a limited period of time.(2) The competent federal authority may revoke the authorisation if the circumstances of the clinical trial do not comply with the information in the request for authorisation or if facts give rise to doubts about the safety or the safety of the patient. the scientific basis of the clinical trial. In this case, the rest of the permit may also be arranged on a temporary basis.(3) Before a decision pursuant to paragraphs 1 and 2, the sponsor shall be given the opportunity to comment within a period of one week. Section 28 (2) (1) of the Administrative Procedure Law applies accordingly. If the competent federal authority orders the revocation, the withdrawal or the revocation of the authorisation with immediate effect, it shall immediately forward this order to the sponsor. Contradiction and challenge have no suspensive effect.(4) If the approval of a clinical trial is withdrawn or revoked or is resting, the clinical trial shall not be allowed to continue.(5) The evaluation by the relevant Ethics Committee shall be withdrawn if the Ethics Committee has subsequently become aware that a reason for failure has been established in accordance with Article 22 (3); it shall be revoked if the Ethics Committee it is subsequently known that
1.
meets the requirements for the suitability of the tester and the test site not given,
2.
does not have proper professional insurance,
3.
Modalities for the selection of the test participants are not in accordance with the state of the medical findings, in particular the clinical trial is not suitable for the detection of the safety, performance or effect of the medical device
4.
The conditions for the inclusion of persons pursuant to § 20 (4) and (5) or (§ 21) are not fulfilled.
paragraphs 3 and 4 apply accordingly. The competent Ethics Committee shall immediately inform the competent authority of the Federal Republic of Germany and the other authorities responsible for the monitoring, stating the reasons.(6) Where the approval of a clinical trial is withdrawn, revoked or the rest of the authorisation is ordered, the competent national authority shall inform the competent authorities and the authorities of the other Member States concerned of the European Economic Area on the action taken and the reasons for it. The second sentence of Article 22a (6) and the second sentence shall apply accordingly. Non-official table of contents

§ 22c Changes after approval of clinical trials

(1) The sponsor shows any change to the documentation of the competent federal authority.(2) If, after approval of the clinical trial, the sponsor intends to make a substantial change, it shall request, indicating the content and reasons of the change,
1.
at the competent federal authority a review and
2.
at the relevant Ethics Committee Review
of the changes that are displayed.(3) In particular, changes that affect
1.
affect the safety of the subjects are considered essential.
2.
can influence the interpretation of the documents on which the conduct of the clinical trial is supported, or
3.
affect the other requirements assessed by the Ethics Commission.
(4) The Ethics Committee takes 30 days after the date of receipt of the amendment Position. The second sentence of Article 22 (4) shall apply accordingly.(5) If the Ethics Committee agrees to the application and does not object to the competent authority within 30 days after the date of receipt of the amendment, the sponsor may carry out the clinical trial in accordance with the amended test plan. In the case of conditions, the sponsor must observe these and adjust the documentation accordingly or withdraw his amendment. Section 22a (6) shall apply accordingly. § 22b shall apply for the withdrawal, revocation and revocation of the approval of the Federal Supreme Authority pursuant to the first sentence of sentence 1.(6) Where significant changes are made to a clinical trial on the basis of measures taken by the competent federal authority, the competent federal authority shall inform the competent authorities and the competent authorities of the other concerned. States Parties to the Agreement on the European Economic Area on the action taken and the reasons for it. The second sentence of Article 22a (6) and the second sentence shall apply accordingly. Non-official table of contents

§ 23 Implementation of the clinical trial

In addition to § § 20 to 22c, the clinical trials of clinical trials are subject to active implantable medical devices, including the provisions of point 2.3 of Annex 7 to Directive 90 /385/EEC and for the conduct of clinical trials of other medical devices, the provisions of point 2.3 of Annex X to Directive 93 /42/EEC. unofficial table of contents

§ 23a reports on cessation or discontinuation of clinical trials

(1) Within 90 days of termination of a clinical trial, The sponsor of the competent federal authority shall report the termination of the clinical trial to the competent authority.(2) In the event of cancellation of the clinical trial, this period shall be reduced to 15 days. All reasons for the cancellation must be reported in the message.(3) The sponsor shall submit the final report to the competent federal authority within twelve months of the termination or conclusion of the clinical trial.(4) In the event of a breach of the clinical trial for safety reasons, the competent federal authority shall inform all the competent authorities, the authorities of the Member States of the European Economic Area and the European Commission. The second sentence of Article 22a (6) and the second sentence shall apply accordingly. Non-official table of contents

§ 23b Exceptions to clinical trial

§ § 20 to 23a are not to be applied if a clinical trial is conducted with Medicinal products which may bear the CE marking in accordance with § § 6 and 10 shall be carried out unless this test has a different intended purpose for the medical product or it is additionally subject to invasive or other stressable conditions. Investigations carried out. Non-official table of contents

§ 24 Performance Evaluation Review

Performance assessment tests of in-vitro diagnostic medical devices are § § 20 to 23b as appropriate, if
1.
is an invasive sampling exclusively or in significant additional quantity for the purpose of assessing the performance of an in-vitro diagnostic tool or
2.
in the context of the performance assessment test additionally invasive or other Incriminating tests are carried out or
3.
the results obtained in the performance assessment should be used for diagnostics without the need for: can be confirmed with established procedures.
In the other cases, the consent of the person from which the samples are taken is required to the extent that the personal right or commercial interests of that person are affected

Fifth section
Surveillance and Protection against Risks

Non-tamded table of contents

§ 25 General Display obligation

(1) Who, as the person responsible for the purposes of § 5, Sentence 1 and 2, has its registered office in Germany and brings medical devices to the market for the first time, with the exception of those pursuant to § 3 No. 8, has this prior to the commencend of the activity , indicating the address of the competent authority, which shall apply exclusively to other establishments and establishments which use medicinal products which are intended to be used in accordance with the conditions of germarm or sterile conditions.(2) Those who make up systems or treatment units according to § 10 para. 1 or sterilize these and medical devices according to § 10 para. 3 and have their registered office in Germany shall have the competent authority, indicating their address before commenced operations indicate the description of the medical devices in question, as well as in the case of systems or treatment units.(3) Anyone who has its registered office in Germany as the person responsible in accordance with § 5 sentence 1 and 2 and brings in in vitro diagnostic medical devices for the first time shall indicate to the competent authority, stating his address, before commence of the activity:
1.
the reagents related to the common technological features and analytes, Medical devices with reagents and calibration and control materials as well as in other in vitro diagnostic medical devices, the appropriate data,
2.
in the case of In vitro diagnostic medical devices, in accordance with Annex II to Directive 98 /79/EC and in vitro diagnostic medical devices, all information enabling the identification of these in vitro diagnostic devices, the analytical and, where appropriate, diagnostic performance data pursuant to Annex I, Section A, point 3 of Directive 98 /79/EC, the results of the performance assessment and the results of certificates,
3.
in the case of a " new In-vitro diagnostic aid "within the meaning of Section 3 (6), additionally stating that it is a" new in vitro diagnostic agent ".
(4) Nightful changes to the particulars referred to in paragraphs 1 to 3 and a cessation of placing on the market shall be made. without delay.(5) The competent authority shall transmit the data in accordance with paragraphs 1 to 4 to the German Institute for Medical Documentation and Information on the central processing and use according to § 33. It shall, on request, inform the European Commission and the other States Parties to the Agreement on the European Economic Area concerning indications referred to in paragraphs 1 to 4.(6) More details on paragraphs 1 to 5 shall be governed by the legal regulation pursuant to § 37 (8). Non-official table of contents

§ 26 Implementation of monitoring

(1) Holds and facilities based in Germany where medical devices are used. prepared, clinically tested, subjected to a performance assessment test, packaged, issued, placed on the market, constructed, operated, used or medicinal products intended for use in accordance with germarm or sterile conditions, prepared , shall be subject to supervision by the competent authorities. This also applies to sponsors and persons who carry out the activities mentioned in the first sentence, as well as to persons and persons ' associations collecting medical devices for others.(2) The competent authority shall be satisfied that the provisions relating to medical devices and advertising in the field of medical care are complied with. It shall examine to an appropriate extent, with particular regard to possible risks, whether the conditions for placing on the market, for putting into service, for setting up, operating and applying are met. The second sentence shall apply in accordance with the monitoring of clinical trials and performance assessment tests, as well as for the monitoring of the preparation of medical devices which are intended to be used in accordance with the conditions of germarm or sterile conditions. The competent authority shall take the necessary measures to eliminate the infringements identified and to prevent future infringements. It may, if there are sufficient indications of an unlawful CE marking or a risk posed by the medical device, require the controller to have the medical device checked by an expert within the meaning of § 5. In the case of an in vitro diagnostic agent in accordance with Section 3 (6), it may, at any time within two years after notification in accordance with Article 25 (3), and thereafter in justified cases, submit a report on the findings of the new experience with the new Require an in vitro diagnostic agent after its first placing on the market.(2a) The competent authorities must have the human and factual equipment necessary to carry out their duties, and the regular training of the general state of science and technology in accordance with the general state of play of the Monitoring staff.(2b) The details of paragraphs 1 to 2a, in particular for the implementation and quality assurance of supervision, shall be governed by a general administrative provision according to Article 37a.(3) The persons responsible for monitoring are authorized to
1.
Land, Business premises, Operating rooms, means of transport and, in order to prevent the risk of public safety and public order, also to enter and visit housing spaces at the usual business hours in which an activity referred to in paragraph 1 is exercised; The fundamental right of the inviolability of the apartment (Article 13 of the Basic Law) is restricted to this extent,
2.
Medical products to be tested, in particular for this purpose in operation , as well as samples taken free of charge,
3.
Documents on development, manufacture, testing, clinical trial, performance assessment test, or The purchase, preparation, storage, packaging, placing on the market and other whereabouts of the medical devices, as well as the advertising material on the market, and, in duly substantiated cases, shall be subject to copies or diversion ,
4.
require all necessary information, in particular the operations referred to in point 3.
(4) Those who follow the supervision referred to in paragraph 1 , shall be subject to the measures referred to in the first sentence of paragraph 3 (1) to (3) and shall assist the persons responsible, as well as the other persons involved in the monitoring, in the performance of their duties. This includes, in particular, the obligation to make medical devices available to these persons, to allow necessary tests, to provide necessary staff and tools, to provide information and to provide documents.(5) In the context of the monitoring of information, the person may refuse to provide information on such questions, the answer to which he or she himself or one of his relatives of the danger referred to in § 383 (1) (1) to (3) of the Code of Civil Procedure criminal prosecution or proceedings under the Law on Administrative Offences.(6) Experts who examine in the context of paragraph 2 shall have the expertise necessary to do so. A certificate issued by a body accredited by the competent authority may also provide evidence of the expertise.7. The competent authority shall, on request, inform the Federal Ministry of Health and the competent authorities of the other States Parties to the Agreement on the European Economic Area on the reviews carried out, their results and the measures taken. Unofficial table of contents

§ 27 Procedure in the event of unlawful and inadmissible affixing of the CE marking

(1) The competent authority shall determine: that the CE marking has been unlawfully affixed to a medical device, the controller is obliged, in accordance with § 5, to fulfil the conditions for the lawful affixing of the CE marking according to the instructions of the competent authority. If these conditions are not met, the competent authority shall restrict the placing on the market of this medicinal product, subject to compliance with certain conditions, to prohibit or to cause the medicinal product to be subject to compliance with certain conditions. from the market. It shall inform the other competent authorities in Germany and the Federal Ministry of Health thereof, which shall inform the European Commission and the other Contracting States of the Agreement on the European Economic Area.(2) If a product unlawfully bears the CE marking as a medical device, the competent authority shall take the necessary measures in accordance with the second sentence of paragraph 1. The third sentence of paragraph 1 shall apply accordingly. Non-official table of contents

§ 28 Procedure for protection against risks

(1) The authority responsible under this law shall take all necessary measures on the protection of the health and safety of patients, users and third parties against dangers arising from medical devices, unless the Atomic Energy Act or a legal regulation based on it for medical devices which produce ionizing radiation or radioactive substances for which the competent authority provides appropriate powers.2. The competent authority shall, in particular, be empowered to take orders, including the closure of the establishment or establishment, in so far as it is necessary to avert an imminent threat to public health, safety or order. It may prohibit, restrict or prohibit the placing on the market, putting into service, operation, use of medical devices and the commencement or further conduct of clinical trials or performance assessment tests. of certain conditions, or order the recall or the assurance of medical devices. It shall inform the other competent authorities in Germany, the competent federal authority, and the Federal Ministry of Health.(3) If the competent authority finds that CE-labelled medical devices or custom-made products may endanger the health or safety of patients, users or third parties or their property, even if installed properly, the competent authority shall: Where it is maintained or used in accordance with its intended purpose, it shall, therefore, take measures with a view to taking the medicinal product off the market or prohibiting or restricting the placing on the market or putting into service, it shall The Commission shall immediately inform the Federal Ministry of Health to initiate a safeguard clause procedure in accordance with Article 7 of Directive 90 /385/EEC, Article 8 of Directive 93 /42/EEC or Article 8 of Directive 98 /79/EC, immediately. In particular, it is necessary to indicate whether the non-compliance with the provisions of this law is due to
1.
non-compliance with the basic requirements,
2.
a failure to apply harmonized Standards or Common Technical Specifications, if their application is claimed, or
3.
a lack of harmonized standards or common technical specifications Specifications themselves.
(4) The competent authority may arrange for all those who may be exposed to a risk posed by a medical device to be referred to this risk in a timely manner. A public warning shall be admissible if, in the event of a risk of default, other equally effective measures cannot be taken or cannot be taken in good time.(5) Measures pursuant to Article 14b of Directive 93 /42/EEC and Article 13 of Directive 98 /79/EC shall be taken by the Federal Ministry of Health pursuant to Article 37 (6) of this Regulation. Non-official table of contents

§ 29 Medical products-Observation and reporting system

(1) The competent federal authority has, if not a top The Federal Office is responsible for the enforcement of the Atomic Energy Act or of the legal regulations issued pursuant to this Act, in order to prevent the health or safety of patients, users or third parties from endangering the health or safety of patients, users or third parties who are involved in the application or use of medical devices risks, in particular side effects, mutual influence with other substances or products, counter-indications, falsification, functional errors, malfunctions and technical defects centrally to be recorded, to evaluate and evaluate. It shall coordinate the measures to be taken, in particular where they affect all serious adverse events during clinical trials or performance assessment tests of in vitro diagnostic medical devices or the following incidents:
1.
any malfunction, failure, or any change in the characteristics or performance of a Medicinal product, as well as any inaccurate nature of the marking or instructions for use, directly or indirectly, for the death or serious deterioration of the state of health of a patient or of a user or of any other person
2.
any reason of a technical or medical nature which, on the basis of the causes referred to in point 1, has the characteristics and the characteristics of the As a result, the manufacturer has led to the systematic recall of medical devices of the same type by the manufacturer.
§ 26 (2) sentence 3 shall apply. The competent federal authority shall communicate the result of the evaluation to the competent authority which decides on the necessary measures. The competent federal authority transmits data from the observation, collection, evaluation and evaluation of risks in connection with medical devices to the German Institute for Medical Documentation and Information on Central Processing and use according to § 33. More details are laid down in Section 37 (8) of the Law.(2) In so far as this is necessary for the performance of the tasks referred to in paragraph 1, the competent authorities may also transmit the name, address and birth date of patients, users or third parties. The competent authority referred to in paragraph 1 may, upon request, inform the competent authority of the competent authority in respect of the cases it has reported and the findings in relation to personal data. In the case of cooperation under paragraph 3, no personal data may be transmitted to patients. Sentence 3 shall also apply to the transmission of data to the information system in accordance with § 33.3. The Authority referred to in paragraph 1 shall act in the performance of the tasks referred to therein with the services of the other States Parties to the Agreement on the European Economic Area and the European Commission, the World Health Organization, the competent authorities of other States responsible for health and safety at work, the authorities responsible for health, occupational safety and health, radiation protection and measuring and calibration, and the other competent authorities in the field of health and safety Federal authorities, notified bodies in Germany, the competent institutions of the statutory accident insurance, the Medical Service of the Federal Association of the Health Insurance Funds, the relevant specialist companies, the manufacturers and distributors as well as with other bodies which, when carrying out their tasks, cover the risks of medical devices. If there is a suspicion that an incident has been caused by the electromagnetic action of a device other than a medical device, the Federal Office of Postal and Telecommunications is to be involved.(4) Details of the performance of the tasks in accordance with § 29 shall be governed by the safety plan in accordance with § 37 (7). Non-official table of contents

§ 30 Security Officer for Medical Devices

(1) Who, as the person in charge, is based in accordance with § 5 sentence 1 and 2 Germany shall, immediately after taking up the activity, determine a person with the expertise required to carry out its duties and the reliability required as a safety officer for medical devices.(2) The person responsible pursuant to § 5 sentence 1 and 2 shall, in so far as he does not exclusively place medical devices on the market for the first time in accordance with § 3 No. 8, notify the competent authority of the security officer as well as any change in the person immediately. The competent authority shall send the data in accordance with the first sentence to the German Institute for Medical Documentation and Information on the central processing and use according to § 33.(3) The proof of the necessary expertise as a safety officer for medical devices is provided by
1.
the certificate of completed natural science, medical or technical college education, or
2.
another education capable of performing the tasks referred to in paragraph 4,
and a minimum of two years of professional experience. The expertise shall be established at the request of the competent authority.(4) The Safety Officer for Medical Devices has made known reports of risks to medical devices, to assess them and to coordinate the necessary measures. He is responsible for the fulfillment of notification obligations, insofar as they concern medical product risks.(5) The safety officer for medical devices shall not be penalised because of the performance of the tasks assigned to him. Non-official table of contents

§ 31 Medical Product Adviser

(1) Who professionally informs professionals or professionals in the appropriate handling of the Medical devices (medical device consultants) may only carry out this activity if they have the expertise and experience required for the relevant medical devices for the information and, where necessary, for the training of the medical devices. Handling of the respective medical devices has. This also applies to the distance oral information.(2) The expertise of who
1.
has an education in a scientific, medical, or has successfully completed a technical profession and has been trained on the relevant medical devices, or
2.
through a minimum of one year's activity, which In justified cases it may also be shorter, experience gained in the information about the respective medical devices and, where necessary, in the instruction in the handling thereof.
(3) The medical device consultant has the competent authority the authority, on request, to demonstrate its expertise. He has the latest knowledge about the respective medical devices in order to be able to advise in a knowledgeable way. The client has to ensure regular training of the medical device consultant.(4) The medical device consultant has written messages from members of the professional circles about side effects, mutual influences, malfunctions, technical defects, contraindications, falsifications or other risks in the case of medical devices to be recorded immediately and in writing to the person responsible pursuant to § 5 sentence 1 and 2 or to his safety officer for medical devices.

Sixth Section
Responsible authorities, Legal Regulations, Other Provisions

Non-official Table of Contents

§ 32 Tasks and responsibilities of the Federal Supreme Authorities in the Medical Product Range

(1) The Federal Institute for Drugs and Medical Devices is in charge of
1.
the tasks according to § 29 (1) and (3),
2.
the technical and medical evaluation Requirements and safety of medical devices, unless this law prescries otherwise or other federal authorities are competent,
3.
Approvals of clinical trials and performance assessment tests in accordance with § § 22a and 24,
4.
Decisions on the delimitation and classification of medical devices according to § 13 Paragraphs 2 and 3,
5.
Special authorisations according to § 11 (1) and
6.
() The Paul-Ehrlich-Institut is responsible for the tasks referred to in paragraph 1, in so far as it is defined in Annex II to Directive 98 /79/EC. In vitro diagnostic medical devices are used to test the safety or tolerability of blood or tissue donations or which relate to infectious diseases. At the Paul-Ehrlich-Institut, a subject-independent test laboratory can be set up, which can work together with notified bodies and other organisations.(3) The Physikalisch-Technische Bundesanstalt (Physikalisch-Technische Bundesanstalt) is responsible for ensuring the uniformity of metrology in medicine and has
1.
Evaluate medical devices with a measurement function and, if designated in accordance with § 15, to carry out type tests,
2.
Develop a reference measurement method, normal measuring instruments and test aids, and check it on request and
3.
scientifically advising the competent authorities and notified bodies.
Table of contents

§ 33 Database-based information system, European database

(1) The German Institute for Medical Documentation and Information sets up an information system on medical devices to support the implementation of the law. of this law and provides the necessary information to the authorities of the federal and state governments responsible for medical devices. It shall make available the necessary data for the European database within the meaning of Article 10b of Directive 90 /385/EEC, Article 14a of Directive 93 /42/EEC and Article 12 of Directive 98 /79/EC. The provision of this information for non-public bodies is permitted, insofar as this is provided for in the legal regulation pursuant to § 37 (8). It may require charges for its services. These are set out in a catalogue of fees, which requires the approval of the Federal Ministry of Health.(2) For the purposes of paragraph 1, the institution referred to in paragraph 1 shall, in particular, have the following tasks:
1.
Processing and use of information pursuant to § 25 (5), also in connection with § 18 para. 3, § § 22a to 23a and 24,
2.
Central processing and use of Basic information on the medical devices placed on the market,
3.
Central processing and use of data from the observation, collection, evaluation and evaluation of Risks related to medical devices,
4.
Information gathering and transmission of data to databases of other Member States and institutions of the European Union Union and other States Parties to the Agreement on the European Economic Area, in particular in relation to the detection and defence of risks associated with medical devices,
5.
Construction and maintenance of access to databases related to medical devices.
(3) The institution referred to in paragraph 1 shall take the necessary measures to ensure that: Data are transmitted only to authorized persons or are given access to these data. Non-official table of contents

§ 34 Export

(1) At the request of a manufacturer or authorised representative, the competent authority shall provide an export Certificate of the traffic capacity of the medical device in Germany.(2) Medical devices subject to a prohibition in accordance with Article 4 (1) may only be carried out if the competent authority of the country of destination has approved the import after they have been approved by the competent authority of the respective prohibitions. has been informed. Unofficial Table Of Contents

§ 35 Fees and Deposits

For individually attributable public services under this Act and the public services to be carried out This law shall be subject to fees and levies in accordance with the provisions of Section 37 (9) of the Regulation. Non-official table of contents

Section 36 Cooperation between the authorities and the notified bodies in the European Economic Area and the European Commission

Competent authorities and notified bodies responsible for carrying out the medical device law shall cooperate with the competent authorities and notified bodies of the other States Parties to the Agreement on the European Economic Area and the European Economic Area. the Commission shall provide each other with the information necessary to ensure uniform application of the provisions adopted for the implementation of Directives 90 /385/EEC, 93 /42/EEC and 98 /79/EC. Non-official table of contents

§ 37 Regulation authorisations

(1) The Federal Ministry of Health is empowered to implement acts of the European Community or the European Union by means of a regulation on the conditions for the issue of certificates of conformity, the implementation of the conformity assessment procedures and their assignment to classes of medical devices as well as special procedures for systems and treatment units.(2) The Federal Ministry of Health is authorized, by means of a legal regulation for medical devices, which is
1.
The health of humans can also be directly or indirectly endangled when used without medical or dental supervision, even if used in accordance with the intended use, or
2.
is often not used to a significant extent in accordance with its intended purpose, if it endangers the health of humans directly or indirectly
is to prescribe the prescription. The legal regulation in accordance with the first sentence may continue to be subject to discharge restrictions.(2a) The Federal Ministry of Health is empowered to establish, by means of a regulation, regulations for the proper conduct of the clinical trial and for the assessment of the performance assessment required for approval and for the achievement of the scientific Knowledge of appropriate documents to be made. In particular, regulations can be made in the legal regulation via
1.
Tasks and the responsibilities of the sponsor, the auditor or other persons performing or controlling clinical trials, including display, documentation and reporting obligations, in particular serious adverse events; that may occur during the examination and may affect the safety of the study participants or the conduct of the study,
2.
Tasks and procedures at Ethics committees, including the documents to be submitted, including information on the appropriate participation of women and men as participants in the examination, the interruption, renewal or reduction of the Period of processing and the special requirements for ethics committees in the case of clinical trials in accordance with § 20 (4) and (5) and § 21,
3.
the tasks of competent authorities and the regulatory approval procedure, including the documents to be submitted, including information on the appropriate participation of women and men as participants in the examination and the interruption of the proceedings or the extension or shortening of the period of processing, the procedure for the verification of documents in establishments and facilities, the conditions and the procedure for the withdrawal, withdrawal and revocation of the authorisation or subjection of a clinical trial,
4.
the requirements for testing equipment, and the keeping and keeping of evidence,
5.
the transfer of the name and seat of the sponsor and the responsible auditor and non-personal clinical examination information from the competent authority to a European database,
6.
the way in which documents are forwarded and the decisions taken by the competent authorities, and those for the examiners, competent ethics committees,
7.
Special regulations for medical devices with a low safety risk.
(3) The Federal Ministry of Health shall be authorised to prescribe distribution channels for medical devices by means of a regulation in so far as it is necessary to obtain the required quality of the medical device or to obtain the necessary quality in the delivery or use of medical devices. Requirements for the safety of the patient, user or third party.(4) The Federal Ministry of Health is empowered to adopt, by means of law, regulations for establishments or facilities (operating regulations) which place or store medical devices in Germany, in so far as it is necessary to: ensure proper operation and the necessary quality, safety and performance of medical devices, and do not endanger the safety and health of patients, users and third parties. The Regulation may, in particular, provide for the storage, purchase, distribution, information and consultation, as well as the instruction in the establishment, including the function test after installation and the application of the Medical devices. The rules may also be applied to persons who carry out the above-mentioned activities in a professional manner.(5) The Federal Ministry of Health is authorized to comply with the provisions of the law
1.
Requirements for the To set up, operate, apply and maintain medical devices, to establish rules on the introduction of operators and users, safety controls, functional tests, reporting requirements and details of the Reporting requirements for incidents and risks, the inventory and the medical device book, as well as other requirements, to the extent that this is necessary for safe operation and safe use or proper maintenance
1a.
To establish requirements for the safe treatment of medicinal products intended for use in accordance with germarm or sterile conditions, and to make arrangements
a)
Additional requirements for conditiers, medical devices with particularly high requirements preparing to dress up,
b)
Certification of conditers according to point (a),
c)
the requirements for the compliance assessment bodies recognized by the competent authority that make certifications as referred to in point (b
2.
a)
Requests to the Quality assurance system when operating and applying in-vitro diagnostics,
b)
Rules to be taken over
aa)
the determination and application of quality assurance standards, the procedures used to create Guidelines and recommendations, the areas of application, content and responsibilities, the involvement of the parties concerned, and
bb)
Scope, frequency and procedures of the control, as well as the requirements for the authorities responsible for the control and the procedure of their order
c)
to determine that the standards, Guidelines and recommendations or their findings are published by the Federal Ministry of Health in the Federal Gazette
Bundesanzeiger)
3.
to ensure the Measurement safety of medical devices with measuring function to determine those medical devices with measuring function subject to metrological controls, and to determine that the operator, a suitable body or the competent authority to carry out metrological checks and to lay down rules on the scope, frequency and procedure of metrological checks, the conditions, the scope and the procedure for the recognition and supervision with the To carry out metrological inspections and to carry out the duties of the operator of a medical device with a measuring function in the case of metrological controls.
(6) The Federal Ministry of Health is authorized to carry out (a) a specific medical device or a group of medical devices for health and safety reasons or in the interest of public health in accordance with Article 36 of the Treaty on the Functioning of the To prohibit or restrict the provision of such a Union or to impose special conditions on it.(7) The Federal Ministry of Health is authorized to draw up a safety plan for medical devices by means of a regulation on the implementation of the tasks related to the medical device observation and reporting system in accordance with § 29. This shall in particular include the tasks and cooperation of the authorities and bodies involved and the inclusion of the manufacturers and agents, importer, placing on the market and other distributors, users and operators, of the The European Commission and the other States Parties to the Agreement on the European Economic Area shall determine the measures to be taken and the measures to be taken. The safety plan may also provide details of the risk assessment and its implementation, duty of involvement of those responsible pursuant to § 5 Sentence 1 and 2, other traders, users, operators and maintenance personnel, details of the notification procedure and their publication, reporting, reporting, recording and storage obligations, audits and production monitors, details of the implementation of risk-prevention measures and their monitoring, as well as information requirements, means, and -routes are regulated. In addition, the safety plan may be used to regulate personal data, insofar as these are recorded, processed and used in the context of the risk prevention.(8) The Federal Ministry of Health is authorized to regulate, in order to ensure the proper collection, processing and use of data in accordance with § 33 (1) and (2) by means of a legal regulation, also with regard to the nature, scope and the Requirements for data. This legal regulation may also determine the fees for acts of this institute.(9) The Federal Ministry of Health is authorized to determine the chargeable facts in accordance with § 35 for the area of the Federal Administration by means of a decree-law and to provide fixed rates or framework rates in the process. The rates shall be calculated in such a way as to cover the personnel and material costs associated with the public services which are individually attributable to the public. It may be determined in the regulation that a fee may also be levied on a service which has not been brought to an end, if the reasons for this are to be found by the person who has led the performance.(10) The Federal Ministry of Health is authorized by means of a regulation to fulfil obligations arising from intergovernmental agreements or for the implementation of legal acts of the Council or of the European Commission, which shall: The subject matter of this Act concerns, in particular, the safety and medical requirements, the manufacture and other conditions of placing on the market, the operating system, the application, the exhibition, in particular tests, production monitoring, certification, labelling, storage and notification obligations, official measures and requirements for the designation and supervision of notified bodies.(11) The legal regulations referred to in paragraphs 1 to 10 shall be adopted with the consent of the Federal Council and in agreement with the Federal Ministry of Economics and Technology. In agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, they shall be responsible for the production of radioactive substances or ionizing radiation, in so far as radiation protection is concerned or is a medical device. , and in agreement with the Federal Ministry of Labour and Social Affairs, to the extent that occupational health and safety is affected and in agreement with the Federal Ministry of the Interior, insofar as data protection is concerned.(12) The legal regulations referred to in paragraphs 6 and 10 do not require the approval of the Bundesrat at the risk of delay or, if it does not enter into force, for the implementation of acts of the European Community or of the European Union is required. The legal regulations referred to in paragraphs 1 to 3 may be adopted without the consent of the Federal Council, if unforeseen health hazards so require. Insofar as the legal regulation in accordance with paragraph 9 concerns charges and levies by federal authorities, it does not require the approval of the Federal Council. The legal regulations according to sentences 1 and 2 do not require the agreement with the respective federal ministries involved. They shall not enter into force no later than six months after their entry into force. Your period of validity can only be extended with the approval of the Federal Council. As far as radiation protection is concerned, paragraph 11 remains unaffected. Non-official table of contents

§ 37a General administrative provisions

The Federal Government, with the consent of the Federal Council, shall adopt the implementing measures this law requires general administrative provisions, in particular for the implementation and quality assurance of the supervision, the expertise of the persons responsible for monitoring, the equipment, the exchange of information and the Collaboration between authorities.

Seventh Section
Special Rules for the Bundeswehr Area

Non-official table of contents

§ 38 Application and enforcement of the law

(1) This law applies to institutions serving the Bundeswehr with medical devices, corresponding to the Application.(2) In the area of the Bundeswehr, the enforcement of this law and the supervision shall be the responsibility of the respective competent authorities and experts of the Bundeswehr. Non-official table of contents

§ 39 Exceptions

(1) Write the basic requirements in accordance with § 7 the indication of the decay date, this can be done at Medical devices that are delivered to the Bundeswehr. The Federal Ministry of Defence ensures that the quality, performance and safety of medical devices are guaranteed. The first sentence shall apply to medical devices submitted to the competent federal or state authorities for the purpose of civil protection and civil protection. The competent authorities shall ensure that the quality, performance and safety of medical devices are guaranteed.(2) The Federal Ministry of Defence may, in agreement with the Federal Ministry of Health and, insofar as occupational health and safety is concerned, in agreement with the Federal Ministry of Labour and Social Affairs, in agreement with the Federal Ministry of Labour and Social Affairs, in accordance with Exceptions to this Act and legal regulations adopted pursuant to this Act, where acts of the European Community or of the European Union do not preclude them and do so in order to implement the special provisions of this law.

Achter Section
Criminal and Penal Regulations

unofficial table of contents

§ 40 criminal rules

(1) imprisonment of up to three years or a fine is punishable by a person who is
1.
contrary to § 4 para. 1 no. 1, a medical device is placed on the market, constructed, operating, operating
2.
contrary to the first sentence of Article 6 (1), a medical device subject to the provisions of the Radiation Protection Regulation or the X-ray Ordinance, or in the case of which: Production of ionizing radiation was used, placed on the market or put into service,
3.
contrary to § 6 para. 2 sentence 1 in conjunction with a legal regulation in accordance with Article 37 (1), a medical device which is subject to the provisions of the Radiation Protection Regulation or the X-ray Regulation or which has been used to produce ionizing radiation, is marked with the CE marking or
4.
contrary to § 14 sentence 2, a medical device operates or applies a medical device.
(2) The attempt is punishable.(3) In particularly serious cases, the penalty shall be a term of imprisonment of one year to five years. A particularly serious case is usually present when the offender is through one of the actions referred to in paragraph 1
1.
the health of a large number of people at risk,
2.
another in the danger of death or of serious injury to body or health, or
3.
obtained from gross self-interest for itself or another asset advantage of a large scale.
(4) If the offender acts negligently in the cases referred to in paragraph 1, the penalty shall be a custodial sentence of up to one year or a fine. Non-official table of contents

§ 41 Penal rules

Imprisonment of up to one year or a fine is punishable by a person who is
1.
contrary to § 4 para. 2 sentence 1 in conjunction with sentence 2, a medical device in the traffic
2.
contrary to § 6 (1) sentence 1, a medical device which is not subject to the provisions of the Radiation Protection Ordinance or the X-ray Ordinance or in the case of which Production of ionizing radiation is not used, placed on the market or put into service,
3.
contrary to § 6 para. 2 sentence 1 in conjunction with a Regulation pursuant to Section 37 (1) of a medical device which is not subject to the provisions of the Radiation Protection Ordinance or the X-ray Ordinance or which did not use ionizing radiation during its production, with the CE marking
4.
contrary to § 20 (1) sentence 1 or sentence 4 (1) to (6) or (9), also in connection with § 20 (4) or (5) or § 21 (1) or (21), respectively, or In contrast to § 22b, paragraph 4, the clinical trial begins, a clinical trial is conducted or a clinical trial is continued,
5.
contrary to § 24 sentence 1 in A connection with § 20 (1) sentence 1 or sentence 4 (1) to (6) or (9), also in connection with § 20 (4) or (5), or contrary to § 24 sentence 1 in conjunction with Section 22b (4), begins with a performance assessment test, a Performing a performance assessment test or continuing a performance assessment test or
6.
is contrary to a legal regulation pursuant to § 37 (2) sentence 2, insofar as it applies to: referred to this penalty.
Non-official table of contents

§ 42 Penal rules

(1) who is negligent in taking any of the acts referred to in § 41.(2) The offence is unlawful, who intentionally or negligently
1.
contrary to § 4 (1) no. 2 Medical product on the market brings, builds, operates, operates, operates or applies it,
2.
contrary to § 9 para. 3 sentence 1, a CE marking is not correct or not in of the prescribed manner,
3.
contrary to § 10 (1) sentence 2 or paragraph 3 sentence 1, also in conjunction with sentence 2, in connection with a legal regulation in each case 4.
4.
contrary to § 10 para. 4 sentence 2 of a medical device, a medical device is not a right, not complete or not in good time, a
Information not included,
5.
in violation of § 11, paragraph 2, sentence 1, or paragraph 3a, a medical device,
6.
contrary to § 12 para. 1 sentence 1 in conjunction with a legal regulation pursuant to § 37 para. 1 a special production is placed on the market or put into service,
7.
contrary to § 12 para. 2 sentence 1 or para. 3 sentence 1 a medical device,
8.
contrary to § 12 para. 4 sentence 1 a medical device,
9.
applying an in vitro diagnostic test against § 12 para. 4 sentence 3,
10.
contrary to § 20 para. 1 sentence 4 no. 7 or 8, also in conjunction with § 21 No. 1, a clinical trial,
11.
contrary to § 25 para. 1 sentence 1, para. 2, 3 or 4 or § 30 para. 2 sentence 1 an advertisement not, not correct, not fully or not reimbursed in time,
12.
contrary to § 26 para. 4 sentence 1 a measure not tolerated or a person not supported,
13.
§ 30 para. 1 a security officer not or not in time determined,
14.
contrary to § 31 (1) sentence 1, also in conjunction with sentence 2, an activity ,
15.
contrary to § 31 (4), a notice is not, not correct, not complete or not in the prescribed manner, or not, or not, or not
16.
of a legal regulation pursuant to § 37 (1), (2a), (3), (4) sentence 1 or 3, (5) (1), (1a), (2) (a) or (b) double-letter (bb) or (3), Paragraph 7 or 8, sentence 1 or of a enforceable order shall be contrary to such a decree, in so far as the legal regulation refers to that fine for a particular offence.
(3) The administrative offence may be is punishable by a fine of up to twenty-five thousand euros. Non-official table of contents

§ 43 confiscation

Items to which an offence is committed pursuant to § 40 or § 41 or an administrative offence pursuant to § 42 , can be drafted. Section 74a of the Criminal Code and § 23 of the Code of Administrative Offences shall apply.

Neunter Section
Transitional provisions

unofficial table of contents

§ 44 transitional provisions

(1) medical devices with expiry date that are before the 30. June 2007 for the purpose of civil protection and civil protection to the competent authorities of the federal or state governments or to carry out their special tasks to the Bundeswehr, may also be applied after expiry of the expiry date. The competent authorities shall ensure that the quality, performance and safety of medical devices are guaranteed.(2) Medical devices within the meaning of § 3 No. 3 shall be subject to the provisions of this Act as from 13. 1 June 2002. Medical devices according to § 3 no. 3 may still be used until 13. December 2005, after the Germany will be placed on the market for the first time in Germany in December 2000. The further placing on the market and the commissioning of the medical devices placed on the market for the first time is up to the 13th. December 2007.(3) The provisions of § 14 as well as the legal regulation pursuant to § 37 (5) shall apply irrespective of the regulations according to which the medical devices have been placed on the market for the first time.(4) For clinical trials in accordance with § 20 and performance assessment tests in accordance with § 24 of the Medical Devices Act, with those before the 20. § § 19 to 24 of the Medical Devices Act (Medical Devices Act) in the version of the notice of 7 March 2010 was initiated. August 2002 (BGBl. 3146), as last amended by Article 1 of the Law of 14. June 2007 (BGBl. 1066), it has been amended to continue to apply.(5) For clinical trials and performance assessment tests as referred to in paragraph 4, the following shall apply from the 21. March 2010, the Medical Devices Safety Planning Ordinance of 24 March 2010 June 2002 (BGBl. 2131), as last amended by Article 3 of the Law of 14. June 2007 (BGBl. 1066), as amended by Article 3 of the Law of 29 June 2003, which is amended by Article 3 of the Law of the European Union (OJ L 327, 29.10.2003, p. July 2009 (BGBl. I p. 2326).

Related Laws