Ordinance on the setting up, operation and application of medical devices (Medical Devices Operator Regulation-MPBetreibV)

Unofficial table of contents

MPBetreibV

Date of completion: 29.06.1998

Full quote:

" Medical Devices-Operator Regulation as amended by the Notice dated 21 August 2002 (BGBl. 3396), as last amended by Article 3 of the Regulation of 11 December 2014 (BGBl I). 2010).

Status:	New by Bek. v. 21.8.2002 I 3396;
	Last amended by Art. 3 V v. 11.12.2014 I 2010

For more details, please refer to the menu under Notes
The obligations laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the provisions relating to the services of The Information Society (OJ C EC No 37), as amended by Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998 (OJ L 136, 31.5.1998, p. EC No 18), have been observed.

Footnote

(+ + + Text evidence from: 7.7.1998 + + +) 
(+ + + Official notes of the norm provider on EC law: 
 Consideration of 
 EWGRL 189/83 (CELEX Nr: 383L0189) 
 Consideration of 
 ERL 34/98 (CELEX Nr: 398L0034)  Bek.  v. 21.8.2002 
 I 3396 + + +) 

  

Section 1
Scope and general provisions

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§ 1 Scope

(1) This Regulation shall apply to the setting up, operation, application and maintenance of medical devices according to § 3 of the Medical Devices Act, with the exception of medical devices for clinical examination or performance assessment. (2) This Regulation does not apply to medical devices which do not serve commercial or economic purposes, and which do not employ workers in the area of danger. Unofficial table of contents

§ 2 General requirements

(1) Medical devices may only be constructed, operated, applied and used in accordance with the provisions of this Regulation, the generally accepted rules of technology and occupational safety and accident prevention regulations, in accordance with the provisions of this Regulation. (2) Medical devices may only be constructed, operated, applied and kept in a state which has the necessary training or knowledge and experience. (3) Medical products associated with each other, as well as with accessories, including software or with other objects Medical devices may only be operated and applied if they are suitable for this purpose, taking into account the intended purpose and the safety of patients, users, employees or third parties. (4) The operator shall only be allowed to use (5) Before applying a medical device, the user shall be responsible for the functioning of the medical device and the condition of the medical device. to convince the medical product and the instructions for use as well as the other Attached safety-related information and maintenance instructions. The first sentence shall be applicable to medical devices connected with the medical device and accessories, including software and other objects. (6) Medical devices of Appendix 2 may only be operated and applied if: comply with the error limits according to § 11 (2). (7) If medical devices are constructed, operated or used in areas where the atmosphere can be explosive due to local or operational conditions, the Regulation on electrical installations in potentially explosive atmospheres in the Version of the notice of 13 December 1996 (BGBl. (8) The provisions relating to the recurrent tests of medical devices in accordance with the accident prevention regulations shall remain unaffected, unless the scope of the test is to be found in the safety-related controls according to § 6. Unofficial table of contents

§ 3 Maintenance of medical devices

(1) The maintenance of medical devices includes, in particular, maintenance measures and repair. Maintenance measures are, in particular, inspections and maintenance required to ensure the safe and proper operation of the medical devices. The maintenance measures shall be carried out in the light of the information supplied by the manufacturer to which this information shall be attached to the medical device. The repair includes, in particular, the repair for the restoration of the functionality. (2) The operator shall only be responsible for the maintenance of the maintenance of persons, establishments or facilities which have been installed.

1.

have the necessary expertise due to their training and practical work; and

2.

have the necessary resources, in particular spaces, equipment and other means of work, to ensure that this task is properly carried out;

(3) After the maintenance referred to in paragraph 1, the essential constructional elements for the safety and operation of the medical devices must be: (4) The persons, establishments or bodies responsible for carrying out the tests referred to in paragraph 3 shall be subject to the conditions laid down in paragraph 2. , and in carrying out and evaluating the tests in their Be independent of an expert assessment. Unofficial table of contents

§ 4 Processing of medical devices

(1) The preparation of medicinal products intended for use in accordance with germarm or sterile conditions shall be carried out, taking into account the information supplied by the manufacturer, with appropriate validated procedures, in such a way as to ensure that the success of these procedures is guaranteed in a comprehensible way and the safety and health of patients, users or third parties is not endangered. This also applies to medical devices disinfected or sterilized prior to the first application. (2) A proper preparation as referred to in the first sentence of paragraph 1 is presumed if the Commission's joint recommendation for hospital hygiene and Prevention of infection at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices to meet the requirements of hygiene in the preparation of medical devices. The site is published by the Federal Ministry of Health in the Federal Gazette (Bundesanzeiger). (3) For the preparation of medical devices with particularly high requirements for preparation ("Critical C") according to the recommendation referred to in paragraph 2, the Certification of the quality management system by a body recognised by the competent authority in accordance with the third section of the law on medical devices. (4) § 3 (2) shall apply accordingly.

Footnote

§ 4 (3) italic pressure: occurs gem. Art. 6 para. 2 V v. 25.7.2014 I 1227 mWv 1.10.2015 in force Unofficial table of contents

§ 4a Quality Assurance in Medical Laboratories

(1) Anyone who carries out laboratory medical examinations shall have a quality assurance system in accordance with the generally accepted state of medical science and technology in order to maintain the required quality, safety and performance to establish the use of in vitro diagnostics and to ensure the reliability of the results obtained. Proper quality assurance in medical laboratories is presumed if Parts A and B1 of the Directive of the Federal Medical Association for Quality Assurance Laboratory Medical examinations of 23 November 2007 (Deutsches Ärzteblatt) (2) Those who carry out quantitative laboratory medical examinations in the field of medicine, with the exception of dentistry, shall be required to comply with the provisions of Annex 1 to the Directive of the Federal Medical Association. Quality assurance of quantitative laboratory medical examinations of the 24. August 2001 (Deutsches Ärzteblatt 98, S. A 2747), which was last amended by decision of the Executive Board of the Federal Medical Association of 14 November 2003 (Deutsches Ärzteblatt 100, S. A 3335), or the one in Table B1 of the Directive of Federal Medical Association for Quality Assurance Laboratory Medical Investigations of 23 November 2007 (German Medical Gazan 105, pp. A 341 to 355), the measurement results are the results of checks (internal quality assurance) and by participating in a comparative study per unit of measurement per quarter (ring trials- (3) As from 1 April 2010, the internal and external quality assurance referred to in paragraph 2 shall be carried out only in accordance with the Directive referred to in the second sentence of paragraph 1. (4) The documents relating to the established The quality system, the control tests carried out and the certificates of participation in the ring trials and the certificates of EQS granted shall be kept for a period of five years, provided that other Regulations are not required for a longer retention period. The documents shall be submitted to the competent authority upon request.

Section 2
Specific rules for active medical devices

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§ 5 Operating and applying

(1) The operator may only operate a medical product listed in Appendix 1 if the manufacturer or a person authorised to do so, who is acting in agreement with the manufacturer, has previously been authorised to do so.

1.

the medical device has undergone a functional test at the place of operation, and

2.

the person instructed by the operator, on the basis of the instructions for use and the accompanying safety-related information and maintenance instructions, into the correct handling, application and operation of the medical device as well as into the permissible Connection with other medical devices, objects and accessories has been admitted.

A referral under point 2 is not required if it has already been carried out for a medical device. (2) Medical devices listed in Appendix 1 may only be used by persons who are subject to the conditions laid down in § 2 para. 2 and which have been instructed by the manufacturer or by a person commissioned by the operator in accordance with paragraph 1 (2), taking into account the instructions for use, into the appropriate handling of this medical device. (3) The implementation the function test referred to in paragraph 1, point 1, and the designation of the operator by the operator (4) Paragraph 2 shall not apply to medical devices listed in Appendix 1 which, according to the labelling, instructions for use or advertising materials, by the group of persons referred to in Article 3 (15) of the Medical Devices Act is intended for use by laymen. Obligations under other provisions shall not be affected by this. Unofficial table of contents

Section 6 Safety and security checks

(1) In the case of medical devices for which the manufacturer has prescribed safety checks, the operator shall have the following information, in accordance with the manufacturer ' s specifications and the generally accepted technical rules, and in the manufacturer ' s specifications, as specified by the manufacturer. Deadlines for carrying out or having to be carried out. To the extent that the manufacturer does not require safety checks for the medical devices listed in Appendix 1 and has not expressly excluded them, the operator has to carry out safety checks in accordance with the general rules of the to carry out or have carried out, in such time-limits, the recognised rules of technology with which it is possible to identify in good time the relevant deficiencies which have to be expected on the basis of experience. However, the checks referred to in the second sentence shall be carried out at least every two years. The safety controls include the measurement functions. In the case of other medical devices, accessories, software and other objects which the operator uses in the case of medical devices according to sentences 1 and 2, the rates 1 to 4 shall apply. (2) The competent authority may, in individual cases, be subject to the deadlines for: (1), first and third sentences, at the request of the operator, in justified cases, to the extent that security is ensured in other ways. (3) The security control shall be subject to a protocol which shall be the date of implementation and the date of the application. Results of the safety-related control, indicating the determined Measurement values, measurement methods and other assessment results. The protocol must be kept by the operator at least until the next safety-related control. (4) Safety-related control must be carried out only if:

1.

provide assurance, on the basis of its training, knowledge and practical experience, for the proper implementation of safety checks;

2.

is not subject to instruction in respect of control activities; and

3.

has suitable measuring and testing equipment.

The conditions laid down in the first sentence must be proved by the person carrying out safety checks at the request of the competent authority. (5) The operator shall only be able to carry out safety checks on persons , who fulfil the conditions laid down in the first sentence of paragraph 4. Unofficial table of contents

§ 7 Medical Product Book

(1) For the medical devices listed in Annexes 1 and 2, the operator shall have a medical product book containing the information referred to in the first sentence of paragraph 2. All data carriers shall be permitted for the medical product book, provided that the information referred to in the first sentence of paragraph 2 is available for the duration of the retention period. A medical device book in accordance with the first sentence is not to be used for electronic fever thermometers as compact thermometers and blood pressure gauges with mercury or aneroid manometers for non-invasive measurement. (2) The medical product book is the following: To enter information on the relevant medical device:

1.

Name and other information on the identification of the medical device,

2.

Receipt of the function test and instruction in accordance with § 5 (1),

3.

the name of the person appointed pursuant to section 5 (1) (2), the date of the instruction and the names of the persons who have been admitted,

4.

the time-limits and the date of implementation, as well as the result of the prescribed safety and metrological checks and the date of maintenance, and the name of the person responsible or of the firm which carried out this measure,

5.

where there are contracts with persons or institutions for the implementation of security or metrological checks or maintenance measures, their name or company name and address,

6.

the date, nature and consequences of malfunctions and repeated similar operating errors;

7.

Notifications of incidents to authorities and manufacturers.

In the case of the information referred to in point 1, the name should be used in accordance with the nomenclature for medical devices published by the German Institute for Medical Documentation and Information (DIMDI). The Federal Ministry of Health is aware of the reference source of the relevant nomenclature for medical devices in the Federal Gazette (Bundesanzeiger). (3) At the request of the place of business, the competent authority shall at any time be aware of the medical product books. . Unofficial table of contents

§ 8 Inventory list

(1) The operator shall keep an inventory of all active non-implantable medical devices in the respective establishment as referred to in the first sentence of paragraph 2. Inclusion in a list which is based on other provisions shall be permitted. (2) For each medical device referred to in paragraph 1, the following information shall be entered in the inventory:

1.

Name, type and type, lot code or serial number, purchase year of the medical device,

2.

name or company and the address of the person responsible for the relevant medical device according to § 5 of the Medical Devices Act,

3.

the identification number of the notified body added to the CE marking, to the extent that it is specified in accordance with the provisions of the Medical Devices Act,

4.

where available, company identification number,

5.

location and operational allocation,

6.

the time limit specified by the manufacturer for the safety-related control according to § 6 (1) sentence 1 or the time limit for the safety-related control specified by the operator pursuant to section 6 (1) sentence 2.

In the case of the information referred to in point 1, the name should also be used in accordance with the nomenclature for medical devices published by the German Institute for Medical Documentation and Information (DIMDI). Article 7 (2) sentence 3 applies accordingly. (3) The competent authority may release operators from the obligation to maintain a list of stocks or from the inclusion of certain medical devices in the inventory. The operator must give a detailed explanation of the need for exemption. (4) All data carriers shall be admissible for the inventory list, provided that the information referred to in the first sentence of paragraph 2 can be made legible within a reasonable period of time. (5) The At the request of the operator, the competent authority shall at all times be granted access to the inventory list. Unofficial table of contents

§ 9 Retenation of the Instructions for Use and Medical Product Books

(1) The instructions for use and the instructions attached to the medical device must be kept in such a way that the information required for the application of the medical device is accessible to the user at all times. (2) The medical product book is so to keep the information available to the user during working hours. After the withdrawal of the medical device, the medical device book is to be kept for another five years. Unofficial table of contents

§ 10 Patient information for active implantable medical devices

(1) The person responsible for the implantation has to hand in written information to the patient who has been implanted an active medical device after the completion of the implantation, in which the person responsible for the safety of the patient after the implantation has been completed. Implantation necessary behavioural instructions are contained in a generally understandable way. In addition, this information must contain details of the measures to be taken in the event of an incident with the medical device and in which cases the patient should consult a doctor. (2) The medicine used for the implantation of an active medical device responsible person shall record the following data and shall accompany the patient information referred to in paragraph 1:

1.

the name of the patient,

2.

Name, type and type, lot code or serial number of the medical device,

3.

name or company of the manufacturer of the medical device,

4.

Date of implantation,

5.

the name of the responsible person who performed the implantation,

6.

Date of subsequent control tests.

The essential results of the control tests should be noted in the patient information.

Section 3
Medical devices with measuring function

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§ 11 Measurement and control checks

(1) The operator shall carry out measurement checks

1.

for the medical devices listed in Appendix 2,

2.

for medical devices not listed in Appendix 2, but for which the manufacturer has provided for such controls,

under the conditions laid down in paragraphs 3 and 4, on the basis of the recognised rules of technology, or to have them carried out. Metrological controls can also be carried out in the form of comparative measurements provided that they are provided for in Appendix 2 for certain medical devices. (2) The metrological controls determine whether the medical device is the Maximum permissible measurement deviations (error limits) according to sentence 2 are maintained. In the case of metrological checks, the fault limits specified by the manufacturer in his use instructions shall be used. If a user instruction does not contain any indication of error limits, it is necessary to comply with specified fault limits in harmonised standards. In the absence of harmonised standards, the state of the art shall be deemed to be based. (3) In the case of metrological controls, provided that no comparison measurements are carried out in accordance with the second sentence of paragraph 1, only metrological standards shall be used which: be connected traceably to a national or international standard, and comply with sufficiently small error limits and measurement uncertainties. The error limits shall be considered to be sufficiently small if they do not exceed one third of the fault limits of the medical product to be tested. (4) The metrological controls of the medical devices referred to in the first sentence of paragraph 1 shall be as far as the manufacturer not otherwise indicated, within the time limits laid down in Annex 2 and in the medical devices referred to in the first sentence of paragraph 1, to be carried out in accordance with the time limits set by the manufacturer. In so far as the manufacturer has not specified any time limits for the medical devices referred to in the first sentence of paragraph 1, point 2, the operator shall carry out or have carried out metrological checks in such time-limits with which such checks shall be carried out on: The reason for the experience must be expected in time, but at least every two years. The same deadlines apply for the repetitions of the metrological checks. The deadlines will begin at the end of the year in which the medical product was put into service or the last metrological control was carried out. A metrological control shall be carried out without delay if:

1.

indications are that the medical device does not comply with the fault limits referred to in paragraph 2; or

2.

the technical characteristics of the medical device may have been affected by an intervention or in some other way.

(5) Metrological checks may only be carried out

1.

competent authorities responsible for metrology, or

2.

Persons who meet the requirements of Section 6 (4) in accordance with metrological controls.

Persons carrying out metrological checks shall, before commencing their duties, notify the competent authority and, at their request, demonstrate the existence of the conditions set out in the first sentence of the first sentence. (6) The operator shall be entitled to: Implementation of metrological checks only authorities or persons who fulfil the conditions laid down in the first sentence of paragraph 5. (7) The person who carries out metrological checks shall have the results of the metrological checks carried out under the control of the Indication of the measured values, the measurement procedures and other To immediately register assessment results in the Medical Product Book, to the extent that this is to be carried out in accordance with § 7 (1). (8) The medical device, which carries out metrological checks, has a successful metrological control with a Characters to be marked. The year of the next metrological control and the authority or person who carried out metrological control must be clear and traceable from the latter.

Section 4
Regulations for the Bundeswehr

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§ 12 Medical Devices of the German Armed Forces

(1) For medical devices in the field of the Bundeswehr, the powers pursuant to § 6 (2) and § 8 (3) as well as the supervision of the implementation of this Regulation are the responsibility of the Federal Ministry of Defense or the competent bodies designated by it. (2) The Federal Ministry of Defence may grant exemptions from the provisions of this Regulation for medical devices in the field of the Bundeswehr, if:

1.

this is justified in order to carry out the specific tasks, or

2.

the particularities of incorporated medical devices so require, or

3.

the fulfilment of intergovernmental obligations of the Federal Republic of Germany so require

and security, including measurement security, is ensured in other ways.

Section 5
Irregularities

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§ 13 Administrative Offences

Contrary to the provisions of Section 42 (2) (16) of the Medical Devices Act, those who intentionally or negligently act

1.

, contrary to § 2 (6), operates or applies a medical device,

2.

in accordance with § 3 (2), also in connection with Section 4 (4), a person, an establishment or a facility,

2a.

Contrary to the first sentence of Article 4 (1), the processing of a medical device mentioned therein is not carried out properly,

3.

without the certification according to § 4 (3), a medical device referred to there,

3a.

Contrary to § 4a, paragraph 2, measurement results are not or not prescribed in a prescribed manner,

3b.

, contrary to Article 4a (4), second sentence, a document shall not be presented in due time, or

4.

, contrary to § 5 (1) sentence 1 or (2) or § 15 (5) sentence 1, a medical device operates or applies a medical device,

5.

Contrary to § 6 (1) sentence 1, 2, 3 or 4, in connection with sentence 5, or § 11 (1) sentence 1 or § 15 no. 6, a check is not carried out, is not carried out correctly or not in time, and cannot be carried out in good time,

6.

Contrary to Section 6 (3) sentence 2, a protocol is not kept until the next security-related control,

7.

, contrary to § 6 (4) sentence 1 or section 11 (5) sentence 1 no. 2,

8.

, contrary to Section 6 (5) or § 11 (6), a person is assigned a control,

9.

contrary to § 7 (1) sentence 1 or § 8 (1) sentence 1, in connection with § 15 No. 8, a medical product book or an inventory according to § 8 (2) sentence 1 does not lead, not correctly or not completely,

10.

Contrary to Section 10 (1), information is not provided, not correct, not complete or not to be handed out in good time,

11.

Contrary to Section 11 (5) sentence 2, the inclusion of the activity shall not be indicated by the competent authority,

12.

Contrary to Section 11 (7), registration is not, not correct, not complete or not in good time,

13.

Contrary to Section 11 (8) of the Medical Devices Act, it is not correct or not fully marked, or

14.

contrary to § 15 Nos. 1 or 2 sentence 1, also in conjunction with sentence 2, a medical device operates or continues to operate.

Footnote

Section 13 No. 3 italic print: kick in. Art. 6 para. 2 V v. 25.7.2014 I 1227 mWv 1.10.2015 in force

Section 6
Transitional and final provisions

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Section 14 Transitional provisions

(1) Insofar as a medical product which has been placed on the market or put into service pursuant to § § 8, 10, 11 (1) or § 12 (1) of the Medical Devices Act, has been operated or applied before 7 July 1998,

1.

the function test and instruction in accordance with § 5 (1),

2.

the safety checks in accordance with § 6 (1),

3.

the Medical Product Book according to § 7 (1) and the inventory according to § 8 (1) and

4.

the metrological controls according to § 11 (1)

by 1 January 1999 at the latest of this Regulation, or established. Sentence 1 shall apply to points 2 and 4 in so far as the time limits laid down in this Regulation have expired until 7 July 1998. (2) Insofar as an operator before 7 July 1998, an instrument book according to § 13 of the Medizingeräteverordnung of 14 January 1985 (BGBl. 93), as last amended by Article 12 (56) of the Law of 14 September 1994 (BGBl I). 2). (3) For the medical measuring instruments listed in Appendix 2, which are based on the requirements of § § 1, 2 and 77 (3) of the Eichordnung of the German-language 12 August 1988 (BGBl. 1657), as last amended by the Regulation of 21 June 1994 (BGBl I, p. 1293), which had to be calibrated or serviced on 31 December 1994, or for which compliance with the authorisation had to be certified in accordance with these provisions, shall be valid from 14 June 1998 § 11 with the proviso that the Metrological controls shall be carried out in accordance with the requirements of Appendix 15 or Annex 23, Section 4 of the Verification Ordination, in the above-mentioned version. Unofficial table of contents

Section 15 Special provisions

For medical devices which may be placed on the market in accordance with the provisions of the Medizingeräteverordnung, the provisions of this Regulation shall apply with the following measures:

1.

Medical devices according to § 2 no. 1 of the Medizingeräteverordnung (Medizingeräteverordnung) may only be operated in the cases of § 5 (10) of the Medizingeräteverordnung (Medizingeräteverordnung) if they are approved of the type of medical equipment.

2.

If the type-approval has been withdrawn or revoked, medical devices which have been put into service in the Federal Gazette prior to the publication of the withdrawal or revocation may only be continued if they have been withdrawn or withdrawn from the Federal Gazette. It is not established in the notice pursuant to Article 5 (9) of the Medizingeräteverordnung (Medizingeräteäteverordnung) that risks to patients, employees or third parties are to be feared. This also applies if a type approval is granted pursuant to Section 5 (8) (2) of the Medizingeräteverordnung (Medizingeräteverordnung).

3.

Medical devices, for which an exception has been granted to the operator before the entry into force of the Medical Devices Act, pursuant to § 8 (1) of the Medizingeräteverordnung (Medizingeräteverordnung), may continue to be carried out in accordance with the measures laid down in the exemption authorisation.

4.

The operator of a medical product which, according to Article 8 (2) of the Medizingeräteverordnung, was allowed to deviate from the generally accepted rules of technology, insofar as they relate to the operation of the medical product, may this medical device in the continue to take the form so far as it is as effective as possible. At the request of the competent authority, the operator shall demonstrate that the other measure is equally effective.

5.

Medical devices according to § 2 no. 1 and 3 of the Medizingeräteverordnung may only be used by persons who have been admitted to the appropriate handling on the medical device, taking into consideration the instructions for use. If such medical devices are extended by means of additional devices to combinations of devices, it is necessary to extend the reference to the combination and its special features. Only those persons who are suitable for the instruction and handling of these medical devices on the basis of their knowledge and practical experience must be able to have such persons.

6.

The operator of a medical device according to § 2 no. 1 of the Medizingeräteverordnung (Medizingeräteverordnung) has to carry out or have carried out the safety checks laid down in the type approval in the prescribed extent within the prescribed time limit. In the case of dialysis machines, which are connected to stationary supply and treatment devices, the safety-related control is also to be extended to these devices.

7.

In the case of medical devices according to § 2 no. 1 of the Medizingeräteverordnung (Medizingeräteverordnung), for which type approvals were not required pursuant to § 28 (1) of the Medizingeräteverordnung (Medizingeräteverordnung) or which may be operated pursuant to Section 28 (2) of the Medizingeräteverordnung (Medizingerordin The scope and time limits of the safety inspections are the information in the examination certificates according to § 28 (1) or (2) of the Medizingeräteverordnung (Medizingeräteverordnung).

8.

Inventories and equipment books in accordance with § § 12 and 13 of the Medizingeräteverordnung (Medizingeräteverordnung) may be continued and shall be considered as inventory and medical product book in accordance with § § 8 and 7 of this Regulation.

9.

Without prejudice to the fact that medical devices meet the requirements of § 6 (1) sentence 1 of the Medizingeräteverordnung in individual cases, medical devices may continue to be operated if they

a)

, before the date of entry into force of the accession, the territory referred to in Article 3 of the Agreement has been lawfully operated;

b)

have been erected and put into service until 31 December 1991 and are in accordance with the provisions which have been applied on the day before the date of entry into force of the accession in the territory referred to in Article 3 of the Agreement on the integration of the Community.

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§ § 16 and 17 (amendment of other provisions)

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§ 18

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Annex 1 (to § 5 (1) and (2), § 6 (1) and (7) (1))

Source of the original text: BGBl. I 2002, 3403

1

Non-implantable active medical devices

1.1

Generation and application of electrical energy to directly influence the function of nerves and/or muscles and/or cardiac activity, including defibrillators,

1.2

Intracardial measurement of electrical quantities or measurements of other quantities using electrically operated measuring probes in blood vessels or exposed blood vessels,

1.3

Generation and use of any energy for direct coagulation, tissue destruction or destruction of depositions in organs,

1.4

Direct introduction of substances and liquids into the bloodstream under potential pressure buildup, whereby the substances and liquids can also be prepared or specially treated body's own, the introduction of which can be carried out with a the extraction function is directly coupled,

1.5

mechanical ventilation with or without anaesthesia,

1.6

Diagnosis using imaging techniques according to the principle of nuclear magnetic resonance imaging,

1.7

Therapy with pressure chambers,

1.8

Therapy by means of hypothermia

and

2

Infant incubators and

3

External active components of active implants.

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Annex 2 (to section 11 (1))

(Fundstelle des Originaltextes: BGBl. I 2002, 3404; individual changes, see Footnote)

1	Medical devices subject to metrological controls according to § 11 para. 1 sentence 1 no. 1
R			Review rists in years
1.1	Medical devices for the determination of hearing ability (sound and speech audiometer)		1
1.2	Medical devices for the determination of body temperatures (with the exception of mercury glass thermometers with maximum device)
1.2.1	-	medical electrothermometers	2
1.2.2	-	with replaceable temperature sensors	2
1.2.3	-	Infrared radiation thermometer	1
1.3	Measuring instruments for non-invasive blood pressure measurement		2
1.4	Medical products for the determination of the intraocular pressure (Augentonometer):
1.4.1	-	General	2
1.4.2	-	on the limit value test	5
1.5	Therapy dosimeter in the treatment of patients from outside
1.5.1	with photon radiation in the energy range up to 1.33 MeV
	-	General	2
	-	with a suitable control device, if the operator carries out at least half-yearly control measurements in each measuring range of the dosimeter, records its results and meets the existing requirements	6
1.5.2	with photon radiation in the energy range from 1.33 MeV and with electron beams from accelerators with metrological control in the form of comparison measurements		2
1.5.3	With photon radiation from Co-60 irradiation systems optionally in accordance with 1.5.1 or 1.5.2
1.6	Diagnostic dosimeters for carrying out measuring and testing tasks, provided that they are not subject to the measurement and calibration law in accordance with § 34 (3) of the X-ray Ordinance		5
1.7	Tremble ergometer for the defined physical and reproducible loading of patients		2

2

Exceptions to metrological control deviation from point 1.5.1 shall not be subject to metrological control of therapy dosimeters, which shall be subject to any influence which may affect the accuracy of the measurement, and at least every two years in the the measurement ranges used are calibrated and the results are recorded. The calibration must be carried out by qualified persons, who are determined by the operator, with a therapy dosimeter, the correctness of which has been ensured in accordance with § 11 para. 2 and that in the case of the therapy carrying out the therapy is always available.

3

Metrological controls in the form of comparative measurements in accordance with 1.5.2 shall be carried out by a measuring point authorised by the competent authority.