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05 February 2020

On 26 May 2020, the new Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices (Medical Device Regulation, "MDR") will become effective. The MDR replaces the previous legal bases valid in the European Union for the marketing and monitoring of medical devices, notably Council Directive 93/42/EEC of 14 June 1993 (Medical Device Directive, "MDD").

Up to now, Swiss medical device manufacturers have enjoyed free access to the European Common Market under the Agreement between the Swiss Confederation and the European Community on Mutual Recognition in Relation to Conformity Assessment of 21 June 1999 (Mutual Recognition Agreement, "MRA"). The prerequisite for this has been that the medical products concerned underwent a recognized conformity assessment under Swiss law. An additional conformity assessment under EU law was not required.

For the time being, there is considerable uncertainty as to the extent to which the MRA still provides free market access for Swiss medical devices after the MDR becomes effective on 26 May 2020. The European Commission presently holds that the MRA has to be revised for this purpose. Otherwise, the Swiss market access procedure could no longer be recognized and Switzerland would become a third country with regard to medical devices.

At the same time, the Commission seems to link the revision of the MRA to the conclusion of a comprehensive institutional agreement between Switzerland and the EU. Accordingly, the talks between the President of the Swiss Confederation Simonetta Sommaruga and Commission President Ursula von der Leyen at this year's WEF in Davos did not produce any concrete results.

If no agreement is reached in the coming weeks, Swiss medical device manufacturers will have to prepare for the fact that they will have to meet the requirements of the MDR for third-country nationals from 26 May 2020. In particular, an authorized representative with a registered place of business in an EU member state must be mandated to ensure that the manufacturer's obligations under EU law are complied with and to serve as a contact person for the competent authorities. According to the MDR, this authorization is to be regulated by means of a written contract, whereby the MDR also specifies the content of the regulation.

VISCHER advises Swiss medical device manufacturers concerning measures that have to be taken as a result of the MDR becoming effective on 26 May 2020.

For questions or further information please contact Stefan Kohler or Ann Sofie Benz.

Topics: MDRMedical DevicesMedical Device RegulationConformity AssessmentMutual Recognition

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