¹ Medical devices shall mean all instruments, apparatus, equipment, software, substances, accessories and other medico-technical utensils, used alone or in combination, including software intended to be used specifically For diagnostic or therapeutic purposes, and necessary for the proper functioning of them:

A.

To be applied to the human being;

B.

Whose principal action intended in or on the human body is not obtained by pharmacological, immunological or metabolic means, but whose action can be supported by such means; and

C.

Which serve:

1.

Recognize, prevent, monitor, treat or mitigate diseases,

2.

To recognize, monitor, treat or mitigate injury or disability or to compensate for disabilities,

3.

Analyze or modify the anatomical structure, replace parts of the anatomical structure or analyze, modify or replace a physiological process,

4.

Regulate design or make design-related diagnoses. ¹

² Medical devices are subdivided into:

A.

Conventional medical devices;

B.

In vitro diagnostic medical devices;

C.

Active implantable medical devices.

³ In vitro diagnostic medical devices are all reagents, reagents, calibration materials, control materials, kits, instruments, apparatus, equipment or systems for use in vitro in the examination Samples from the human body, including blood and tissue donations, used solely or primarily for the purpose of providing information:

A.

Concerning physiological or pathological conditions;

B.

Concerning congenital anomalies;

C.

To determine safety and compatibility with potential recipients;

D.

Allowing control of therapeutic measures.

⁴ Active implantable medical devices include all medical devices:

A.

The operation of which depends on an electrical energy source or any other source of energy not directly generated by the human body or gravity;

B.

That are designed to be implanted, in whole or in part, by surgical or medical intervention in the human body or by medical intervention in a natural port; and

C.

Which are intended to remain in place after the intervention.

⁵ Conventional medical devices include all medical devices that are not active implantable medical devices or in vitro diagnostic medical devices.

¹ Custom devices are medical devices that are manufactured for a given patient.

² They must be designed according to the written requirement and under the responsibility of a duly qualified person.

³ The conformity assessment procedure is carried out in accordance with Annex 3.

⁴ Medical devices manufactured in series which must be adapted to meet the specific requirements of the duly qualified person who uses them are not considered to be custom devices.

¹ Conventional medical devices and active implantable medical devices obtained from devitalized human tissue or containing such tissue are subject only to art. 6, para. 3, 26 and 27 and in section 5.

² With respect to conventional medical devices and active implantable medical devices, this order does not apply to:

A. ¹

Human blood, human blood products, human plasma or human blood cells, or devices which, at the time of placing on the market, contain blood, blood products, blood plasma or cells Blood of human origin, unless they are substances which are used separately are considered to be components of medicinal products or as medicinal products derived from human blood or plasma within the meaning of s. 1 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 ² Establishing a Community code relating to medicinal products for human use and which can have an effect on the human body in addition to that of the device;

B. ³

Viable organs, tissues or cells of human origin, or standardized transplants;

C.

Organs, tissues or cells of animal origin, except for medical devices manufactured from devitalized tissues of animal origin or from devitalized products derived from tissues of animal origin.

¹ For the purposes of this order:

A.

Accessory: Any component which, although not a medical device per se, must, according to the job to which the manufacturer is intended, be used with a medical device according to the instructions of the manufacturer of that device;

B. ¹

...

B ^Bis . ²

Medical device manufactured in the facility : a medical device intended for use only in the establishment that manufactured it or in a partner institution integrated into the quality assurance system of the manufacturer;

B ^Ter . ³

System and processing unit Assembly of several conventional medical devices for which the supplier has the corresponding declarations of conformity intended for use by the person responsible for the first placing on the market;

C.

Performance evaluation: Any investigation to establish that an in vitro diagnostic medical device meets the performance requirements under normal conditions of use;

D.

Serious incident: Any event related to the malfunctioning of a medical device or the modification of its essential characteristics, the inadequacy of its labelling or method of use, which has caused or could have led to the death or seriously impair Damage to the health of patients, users or third parties;

E. ⁴

Contracting State : a State which has concluded an international law convention with Switzerland on the mutual recognition of conformity assessments and procedures relating to medical devices;

F. ⁵

Third State: A State which has not concluded an International Law Convention with Switzerland on the mutual recognition of conformity assessments and procedures relating to medical devices.

² A first placing on the market occurs when a new product or product that has been reprocessed or modified in such a way that it no longer serves the intended purpose or provides the intended performance and is handed over or transferred First time in Switzerland for pecuniary interest or not. The use by professionals of a medical device imported directly from a third country or a medical device manufactured in the establishment shall also be regarded as a first placing on the market. ⁶

¹ Essential requirements within the meaning of s. 45, para. 2, LPTh concern:

A.

The conventional medical devices referred to in Annex I to Council Directive 93 /42/EEC of 14 June 1993 ¹ Relating to medical devices (Directive 93 /42/EEC);

B.

In vitro diagnostic medical devices referred to in Annex I to Directive 98 /79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Directive 98 /79/EC) ² ;

C.

The active implantable medical devices referred to in Annex 1 to Council Directive 90 /385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Directive 90 /385/CEE) ³ . ⁴

^1bis Conventional and implantable medical devices which are also machines within the meaning of Directive 2006 /42/EC of the European Parliament and of the Council of 17 May 2006 on machines ⁵ And amending Directive 95 /16/EC (recast) must comply with the essential health and safety requirements set out in Annex I to this Directive, if they are more specific than the essential requirements laid down in para. 1. ⁶

^1ter Conventional medical devices which, in addition to their use of medical devices, are intended for use in accordance with the requirements on personal protective equipment within the meaning of Council Directive 89 /686/EEC of 21 December 1989, concerning the approximation of the laws of the Member States relating to personal protective equipment ⁷ , must also comply with the essential health and safety requirements contained in this Directive. ⁸

² The essential requirements embodied in technical standards ⁹ , common technical specifications ¹⁰ Pharmacopoeial requirements ¹¹ Are presumed to be met if the medical device complies with the said standards, specifications or requirements.

³ The Swiss Institute for Therapeutic Products (institute) sets the common technical standards and technical specifications to fulfil the essential requirements to be met by medical devices; it publishes titles In the Federal Worksheet, with reference to the organizations to which the texts can be obtained.

⁴ The provisions of the Act of 7 October 1983 on the protection of the environment are reserved for the placing on the market of medical devices which are substances or contain organisms. ¹² And the Law of 21 March 2003 on Genetic Engineering ¹³ . ¹⁴

⁵ The classification, packaging and labelling of in vitro diagnostic medical devices and non-invasive conventional medical devices or not directly in physical contact with the body shall be governed by the provisions of the Directive 99 /45/EC of the European Parliament and of the Council of 31 May 1999 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of Dangerous preparations. ^{15 16}

¹ The person in charge of the first placing on the market shall allocate the conventional medical devices to Class I, II A , II B And III according to the risks they may present, taking into account the employment to which they are intended. This classification must comply with the provisions of Annex IX to Directive 93 /42/EEC ² . ^{3 4}

² Any classification already made within the meaning of para. 1 may be resumed for medical devices imported from a Contracting State.

¹ Every person having a seat in Switzerland shall place on the market for the first time, in Switzerland or in a Contracting State, a medical device within the meaning of the let. A to c shall declare to the Institute its name, address and description of the devices concerned, at the latest at the time of placing on the market:

A.

Classical Class I medical devices;

B.

Custom-made devices manufactured from conventional or active implantable medical devices;

C.

Systems and processing units. ²

² Every person who, having its registered office in Switzerland, places on the market for the first time, in Switzerland or in a Contracting State, an in vitro diagnostic medical device shall report to the Institute, at the latest at the time of placing on the market:

A.

Its name and address;

B.

The device intended to be placed on the market, including general indications relating to its technology and its use;

C.

For the devices referred to in Annex II to Directive 98 /79/EC ³ And for self-diagnostic devices: ⁴

1.

The designation of the device,

2.

All data for identifying the device,

3.

Its performance characteristics according to Annex I, section A, c. 3 of Directive 98 /79/EC,

4.

The results of the performance evaluation

5.

Certificates of compliance.

^2bis It is only necessary to declare in vitro diagnostic medical devices manufactured in the facility in the case of medical devices referred to in Annex II to Directive 98 /79/EC. In the case of goods within the meaning of List A of this Annex, the institution is required to attach to the documents referred to in para. 2, let. C, an attestation of its accreditation, authorization or recognition:

A.

If the manufacturer has been designated as a national reference laboratory or is a laboratory with equivalent qualifications; and

B.

If no common technical specification exists for the medical device concerned. ⁵

³ Every person who places on the market in Switzerland a medical device within the meaning of s. 2, para. 1, shall report to the Institute, at the latest at the time of placing on the market:

A.

Its name and address;

B.

The device intended to be placed on the market, including general indications relating to its technology and its use.

⁴ Changes to the data referred to in s. 1 to 3 must be announced as a block at the institute once a year.

¹ Information on the product is governed by:

A.

Conventional medical devices by c. 13 of Annex I to Directive 93 /42/EEC ¹ ;

B.

Implantable medical devices active by c. 14 and 15 of Annex 1 to Directive 90 /385/EEC ² ;

C.

In vitro diagnostic medical devices by c. 8 of Annex I to Directive 98 /79/EC ³ . ⁴

² Information on the product must be in all three official languages. The use of symbols, embodied in harmonised standards, in place of written texts is allowed.

³ Information on the product can be written in less than three official languages, or even in English only. ⁵

A. ⁶

The medical device is intended to be delivered exclusively to professionals or whether it is a custom device or a medical device manufactured in the establishment;

B.

The user has the necessary technical and linguistic skills and is in agreement with the chosen language (s);

C.

The protection of patients, users and third parties is nevertheless assured; and

D.

That this does not affect the efficient and effective use of the device.

⁴ Upon request, users should be able to receive additional information in one of the official languages.

⁵ Where a product is not or not yet intended to be placed on the market as a medical device, but may be confused with such a device, the presentation texts must clearly and legibly indicate that the product is not A medical device and is not suitable for medical purposes.

¹ Medical devices placed on the market in Switzerland shall bear a mark of conformity, in accordance with Annex 1. A foreign conformity mark set out in Annex 2 shall also be permitted.

² No compliance mark is required for:

A.

Custom devices;

B.

Products intended exclusively for demonstrations or exhibitions;

C.

Treatment systems and units;

D.

Products intended for clinical trials;

E.

Products intended for performance evaluation.

³ For in vitro diagnostic medical devices manufactured in the establishment, a mark of conformity is only necessary in the case of medical devices according to Annex II of Directive 98 /79/EC ² No mark of conformity is required for a product listed on list A of this Annex:

A.

Where the manufacturer has been designated as a national reference laboratory or is a laboratory with equivalent qualifications; and

B.

When there is no common technical specification.

⁴ In addition to the conformity mark, medical devices whose conformity is to be assessed by a conformity assessment body according to Annex 3 shall bear the identification number of the conformity assessment body. In the case of foreign conformity marks, the Institute may accept, instead of identification numbers, other indications concerning the conformity assessment body.

⁵ The mark of conformity and, where applicable, the identification number must appear on the medical device itself or, where this is not possible or appropriate, on the packaging and on the instructions for use and, if possible, on the packaging Business. The registration must be clearly visible, easily legible and indelible.

⁶ The Institute may publish the identification numbers or the proxy indications within the meaning of para. 4.

¹ A person who puts a medical device on the market in Switzerland shall, upon request, be able to produce the declaration of conformity to the supervisory authorities in the context of market surveillance.

² A medical device which, having its registered office in Switzerland, places on the market for the first time, in Switzerland or in a Contracting State, must be able to prove that its product complies with the essential requirements and that it is effective And the performance claimed.

³ The Federal Department of the Interior (Department) may, in agreement with the Federal Department of Defence, the protection of the population and sports, grant exemptions for medical devices intended exclusively for use in Movement within the military or in the context of its specific tasks.

⁴ The Institute may, on a case-by-case basis, grant exemptions for non-conforming medical devices:

A.

They serve to avert a mortal danger or to remedy the long-term degradation of a bodily function;

B.

That no conforming medical device is available for the indication considered; and

C.

Their use is limited to individual cases.

¹ The conformity assessment procedure, the certificate of conformity and the declaration of conformity are governed by Annex 3.

² In the event of recourse to a conformity assessment body, all the information necessary for that assessment must be provided to it.

³ Certificates modified, suspended or revoked by a conformity assessment body shall no longer be used in their original form.

¹ Conformity assessment bodies should be:

A. ¹

Accredited by the Swiss Accreditation Service in accordance with the order of 17 June 1996 on accreditation and designation (OAccD) ² And, where an international agreement so provides, designated as such by the Institute; or

B. ³

...

C.

Recognised by Switzerland under an international convention.

^1bis The Institute shall designate only the conformity assessment bodies which fulfil, in addition to the conditions laid down by the OAccD, the conditions set out in Annex 3 A It evaluates the conformity assessment bodies concerned in detail; the evaluation includes an on-the-spot appraisal. ⁴

² The use of foreign bodies not recognised within the meaning of para. 1 is allowed if it can be demonstrated with likelihood to the Institute:

A.

That the procedure for the review or assessment of applied compliance complies with the Swiss requirements; and

B.

That the foreign body has a qualification equivalent to the qualification required in Switzerland.

³ The State Secretariat for the Economy may order, in agreement with the Institute, that the bodies referred to in para. 2 or the certificates they have issued shall not be recognised if the Swiss counterparts or the certificates they have issued are not recognised by the State in which these foreign bodies are established. In so doing, it takes into account not only the interests linked to health policy, but also interests in the national economy and the external economic relations of Switzerland.

¹ The designation shall be granted for a limited period not exceeding five years.

² It may be renewed for periods not exceeding five years each. To do so, an application must be filed before the expiry of its period of validity.

³ The scope of the designation may, upon request, be extended by the Institute.

⁴ The Institute shall carry out the same evaluations, including an on-the-spot appraisal, for renewal and for the extension of the scope of the designation as for the designation. For the renewal of the designation, it can also supervise an audit carried out by the conformity assessment body on the premises of one of its clients.

In the designation procedure, including the renewal and extension of the designation, the Institute shall cooperate with the European Commission and the Member States of the European Union in accordance with Annex 3 B Where an international agreement so provides.

¹ Decisions taken and certificates issued by conformity assessment bodies within the framework of the procedures laid down in Annexes II, III, V and VI to Directive 93 /42/EEC ² In Annexes 2, 3 and 5 to Directive 90 /385/EEC ³ And Annexes III, IV, V and VII to Directive 98 /79/EC ⁴ Are valid for up to five years. Upon request, the duration of the certificates may be extended by five years at most each time.

² The conformity assessment bodies must suspend, revoke or limit any certificate issued by their care if the conditions for granting them are no longer fulfilled.

¹ The conformity assessment bodies shall declare to the Institute all certificates issued, amended, supplemented, suspended, restricted, revoked or refused by their care by indicating the medical devices concerned.

² Conformity assessment bodies shall report to other peer bodies all certificates suspended, revoked or refused by their care by indicating the medical devices concerned. On request, they also provide information on certificates issued, modified or completed, and give them further information on this subject.

¹ The Institute shall monitor conformity assessment bodies according to Art. 32 OAccD ² And Annex 3 C .

² It may at any time:

A.

Conduct on-site assessments, with or without notice;

B.

Supervise audits carried out by conformity assessment bodies on the premises of their clients.

¹ The person responsible for the first placing on the market of a medical device in Switzerland or in a Contracting State shall be required to take the appropriate measures in order to be able, during the specified period of use:

A.

Identify the potential risks associated with the product;

B.

To prevent potential risks;

C.

Trace the product.

² To this end, it establishes an observation system and collects, for each device:

A.

Claims;

B.

Experience in use and effectiveness;

C.

Reports published in the specialized press;

D.

Its own analysis results;

E.

Corrective measures.

³ It must carefully review the product safety claims and, where appropriate, conduct sample checks and take corrective action.

⁴ Any person who subsequently puts a device on the market is required to contribute to compliance with the safety requirements and to participate in the monitoring of the safety of the said device. It collects, for this purpose, the claims and the experiments concerning the use and efficiency of the device and transmits them to the observing system.

¹ If the person responsible for the first placing on the market becomes aware of a serious incident in Switzerland, he is obliged to declare it to the institute. Declarations of serious incidents in a Contracting State must be addressed to the competent authority of the Contracting State concerned.

² Anyone who finds, as a specialist, a serious incident in the use of medical devices must report it to the Institute. The declaration may be made by a professional society.

³ The declaration must be made:

A.

If the incident represents or is likely to represent, clearly and directly, a serious danger to the life or health of many people: without delay, but in any case within two calendar days of the finding;

B.

If the incident resulted in the death of the patient or a serious and unexpected harm to his or her health: without delay, but in any case within ten calendar days of the finding;

C.

In other cases: without delay, but in any case within 30 calendar days of the finding.

⁴ Hospitals shall establish an internal declaration system in accordance with the principles of quality assurance, appoint a competent authority, with appropriate medical or technical training, and inform the institution thereof; Person is responsible for reporting.

Upon request, the Institute may accept that the person in charge of the first placing on the market of a medical device periodically remits summary statements to the Institute if the cause of the incidents is known or if, after the implementation of the withdrawals and Other safety measures referred to in s. 15 C , products with a defect are still on the market.

If the person responsible for the first placing on the market finds, in the context of the observation of the products, a significant increase in the rate of incidents, he must report it to the institute in a trend report and communicate the measures to it Possibly taken.

¹ If the person responsible for the first placing on the market becomes aware of a serious incident involving the use of a medical device, he will adopt the necessary internal measures as well as the safety measures concerning the product placed on the market To reduce the risk, such as withdrawal, exchange, modification, destruction or sending of safety instructions for its use.

² It shall immediately notify the institute of the withdrawal or other safety measures concerning the product placed on the market, if it has been manufactured in Switzerland or if it is marketed. If the product has been manufactured or marketed in a Contracting State, the declaration shall also be addressed to the competent authority of the State concerned.

^2bis In particular, the declaration contains:

A.

All product identification information;

B.

A complete description of the risk posed by the product;

C.

All available information concerning the identity of the person who supplied the product to the person responsible for the first placing on the market, and, unless it has sold it directly to users, the persons to whom it has delivered it. ²

³ It is required to submit to the Institute, within an appropriate time frame, a final report on the measures taken and the effects obtained.

Any person who has placed a medical device on the market shall be required to transmit, in an appropriate manner, to the users concerned and, where appropriate, to patients, information on withdrawals or other safety measures concerning This product.

¹ The Institute provides for the collection, evaluation and, where appropriate, the systematic transmission of declarations.

² It shall inform the cantons and the competent authorities of the Contracting States, as appropriate, of serious incidents. It shall inform them in all cases of the withdrawals made and of the other safety measures concerning the products placed on the market.

³ If necessary, the Institute shall publish in an appropriate manner the withdrawals and other safety measures concerning products placed on the market.

¹ Medical devices for personal use which may endanger human health are subject to medical prescription, even if they are used in the rules of art, as well as medical devices containing medicinal products which are subject to Medical prescription.

² The Institute shall establish by order a list of categories of medical devices subject to medical prescription.

¹ The provision of medical devices must correspond to the intended use and the information provided by the person responsible for the first placing on the market.

² Medical devices subject to medical prescription, medical devices for personal use purchased in self-service and not belonging to Class I, as well as in vitro self-diagnosis medical devices, can be provided only if the Remission point is in a position to guarantee a specialized board and meets the requirements for the operation.

³ The provision to the public of medical devices for the in vitro diagnosis of transmissible human diseases is prohibited. The Institute may grant exemptions in the interest of public health.

⁴ The provision of in vitro diagnostic medical devices manufactured in the facility is prohibited. ¹

¹ Groups of medical devices intended for use by professionals and likely to endanger human health when they are not used in the rules of art are listed in Annex 6.

² The use of the groups of medical devices listed in Annex 6 shall be subject to the conditions laid down in the said Annex with regard to exploitation and professional qualifications.

³ The department has the authority to adapt Annex 6 to technical developments and to add groups of medical devices intended for use by professionals who are likely to endanger human health when they are not Used in the rules of art.

¹ Every professional who uses a medical device on several occasions will ensure, before each reuse, that the device is working properly and that the device has undergone proper reprocessing.

² Any maintenance measures necessary to prepare for the intended use of a used or new medical device, in particular activities such as cleaning, disinfection and sterilization, shall be deemed to be reprocessing.

³ Data on process and validation of sterilization should be recorded.

⁴ Every person who retirements for third-party medical devices is required to prove that she has completed a Schedule 3 conformity assessment procedure for the treatment and sterilization of medical devices.

¹ Every professional who uses a medical device shall ensure that his maintenance and the tests associated with it are carried out in accordance with the legal requirements.

² Maintenance must comply with the principles of quality assurance, be planned within the establishment and be carried out under appropriate conditions; it must be defined according to:

A.

Instructions for maintaining the person responsible for the first placing on the market;

B.

The risks inherent in the device and its use.

³ The results of the maintenance work and the corresponding tests, the defects and malfunctions found and the measures taken to remedy it must be recorded, for the following categories:

A.

Active medical devices;

B.

Medical devices with measurement function that can be calibrated.

⁴ For medical devices with measurement function, the control procedures covered by the order of 15 February 2006 on measuring instruments ¹ Can be scheduled. ²

Any person who modifies or causes to be changed or reintroduced or reintroduced a medical device in a manner that is not in conformity with the intended purpose or in such a way as to modify the performance of the device shall meet the requirements for the first place on the Market.

¹ Advertising for medical devices intended for direct delivery to the public or direct use by the public must be limited exclusively to claims that correspond to the information on the product as regards its use, Its performance and effectiveness.

² Any misleading information about the effectiveness or performance of a medical device is prohibited.

³ No person shall advertise to the public for medical devices:

A.

Subject to medical prescription;

B.

To be used exclusively by professionals.

¹ The Institute may issue an export certificate within the meaning of s. 50, para. 2, LPTh for the export of medical devices to a third country.

² It may issue, on the production of the required documents, an import certificate if a third country requires proof that the medical device under consideration is authorised to be placed on the market in Switzerland.

³ In duly motivated cases, it may link the grant of a certificate to certain conditions.

⁴ It revos a certificate:

A.

It was issued on the basis of false documents;

B.

If the devices concerned no longer benefit from the required declarations of conformity or the corresponding certificates of conformity or if they fall under an import or export ban;

C.

If the medical device concerned presents a danger to the health of users, patients or third parties.

¹ The control within the framework of market surveillance (further control) is intended to ensure that the medical devices placed on the market, the procedures for placing on the market, the observation of products and the use of the Medical devices comply with the provisions of this order. The subsequent control shall also cover medical devices which are placed on the market in a Contracting State by any person having its registered office in Switzerland, as well as on the procedure for placing on the market and the observation of such devices. ¹

² Subsequent monitoring is carried out by taking samples or following serious incidents.

¹ The Institute provides for the further control of medical devices. The jurisdiction of other federal departments or institutions is reserved for certain aspects of this control.

² The cantons are responsible for the following supervision:

A.

In retail outlets and discount points;

B.

The manufacture of custom-made devices, as well as systems and processing units;

C.

The maintenance and reprocessing of medical devices by professionals who use them, except in hospitals. ¹

¹ The Institute may establish a coordinating body. This one:

A.

Coordinates further monitoring and, where appropriate, verification of medical device measurement functions and notification of decisions taken by different authorities;

B.

Acts as an information centre for any question or statement ¹ Relating to medical devices;

C.

Shall communicate to the bodies responsible for subsequent control on a case-by-case basis declarations made in accordance with the procedure laid down in Art. 6.

² The authorities carrying out enforcement tasks in the field of medical devices shall be represented in the coordinating body. The Institute shall take over the Chair and the Secretariat.

³ The other implementing authorities shall inform the Institute of their activities in relation to the subsequent control of medical devices.

In order to verify the conformity of medical devices, the bodies responsible for further monitoring may, on a free basis:

A.

Require the necessary evidence and information;

B.

Taking samples;

C.

Have controls carried out;

D. ¹

Enter, during normal working hours, the commercial premises of persons required to provide information and visit their facilities;

E. ²

Ask to see their documents and require them to be written in one of the official languages or in English.

¹ The competent enforcement bodies shall be empowered to process the personal data they need to perform all the tasks conferred on them by this order. They can also process health data, which are collected as part of official market surveillance (art. 58 and 59 LPTh).

² The processing of personal data is subject to the Federal Law of 19 June 1992 on Data Protection ² .

The person responsible for the first placing on the market of a medical device in Switzerland or in a Contracting State and any person who subsequently puts the product on the market shall be obliged to cooperate at the time of execution. In particular, they must provide all the necessary information to the implementing bodies free of charge, as well as all necessary documents and certificates.

¹ If a medical device does not comply with the legal requirements, the competent authority shall notify the person responsible of its placing on the market of the result of the monitoring procedure and shall give it an opportunity to express its opinion on the matter. The authority may order measures. Where appropriate, it shall give appropriate time for their implementation.

² If there is a suspicion that a medical device, even in accordance with the legal requirements, poses an immediate and serious danger to the health or safety of patients, users or third parties, the implementing bodies concerned shall Immediately the provisions necessary to remove the device from the market, prohibit its placing on the market or bring it into receivership. The Institute shall then take the necessary measures in accordance with Art. 66 LPTh. If the protection of the population so requires, it shall take the measures in the form of a decision of general application. ¹

¹ The Federal Department of the Interior may adapt the Annexes to this Ordinance to the evolution of international standards or technical knowledge.

² It shall make adaptations liable to constitute technical barriers to trade with the agreement of the Federal Department of Economics, Training and Research.

The following legislative acts are repealed:

A.

The order of 24 January 1996 on medical devices ¹ ;

B.

The order of 24 February 1993 concerning in vitro diagnostic kits ² .

¹ Hospitals are putting in place their internal reporting system obeying the principles of quality assurance until 1 ^Er July 2011.

² The cantons carry out checks on the maintenance and reprocessing of medical devices by professionals who use them from 1 ^Er July 2011.

This order shall enter into force on 1 ^Er January 2002.