The agreement 0.946.526.81 on the mutual recognition of conformity assessment (MRA) has made easier, in the last 22 years, the free exchange of goods between the Swiss Confederation and the European Community. Such agreement also covers medical devices.
For this category of products, on 26 May 2021 Regulation 2017/745 EU repealed Directive 93/42/EEC. The European Union and Switzerland have never reached an agreement allowing the update of the mutual recognition agreement within the new legislative framework. Basically, the European Commission subordinates the MRA update to the progress in the institutional agreements, whose negotiation is still going on. The European Commission is only available to negotiate the transitory provisions for medical devices according to the old legislation. Such circumstance implies, thus far, the following consequences:
- For all new devices, companies with legal office in Switzerland intending to market medical devices in a country of the European Union shall comply with the requirements of regulation 2017/745 EU as a third country.
- The existing certificates issued according to Directive 93/42/EEC by Swiss Conformity Assessment Bodies are not valid anymore.
- For the existing certificates issued according to the MRA by Conformity Assessment Bodies established in the EU, Swiss manufacturers as well as those from third countries whose authorised representative was previously established in Switzerland shall appoint an authorised representative established in the EU.
Besides, the Swiss Federal Council has updated the ordinance regarding the medical devices (ODmed) 812.213. Its text regulates the market of medical devices within the confederation.
Among other things, the update includes the acknowledgment of the existing certificates issued according to the MRA by Conformity Assessment Bodies established in the EU as well as the transient timetables for the designation of a representative in Switzerland for EU/EEA medical device manufacturers.
In particular, if the manufacturer is located in an EU or EEA (European Economic Area) State or has given its mandate to a person located in an EU or EEA State, this should appoint an authorised representative for all devices that were marketed after 26 May 2021 within the following deadlines:
- 31 December 2021 for class III medical devices, class IIb implantable devices, and active implantable medical devices;
- 31 March 2022 for class IIb non implantable devices, and class IIa devices;
- 31 July 2022 for class I medical devices.
For systems and procedure kits, the appointment of an authorised representative shall occur within 31 July 2022.
Written by: Antonio Ciriello