The agreement between the EU and Switzerland on mutual recognition in relation to conformity assessment and on removal of barriers to trade in the state-regulated sector (the Mutual Recognition Agreement, or MRA) has not been updated.
This will have serious consequences for the medical device industry: in the absence of an updated MRA, the rules governing the development, manufacture and distribution of medical devices are no longer the same in EU member states and Switzerland ever since the EU Medical Device Regulation (MDR) took effect on 26 May 2021. Swiss medical device manufacturers fall under the rules for third countries from the viewpoint of EU member states, so that Swiss-made medical devices will have to be “imported” into the EU in the future, and the statutory requirements for importers will apply in accordance with Article 14 of the MDR. Swiss manufacturers will have to appoint an authorized representative in order to distribute their products in the EU. This EU authorized representative must have available a competent person with the necessary expertise in EU medical device law. Moreover, the imported products must be labelled as required in the MDR. Medical devices which are approved by the Swiss conformity assessment body will require additional testing and approval before they can be imported into the European market.
The applicable statute in Switzerland as of 26 May 2021 is the Medical Devices Ordinance (MedDO). EU manufacturers (still) planning to distribute their products in Switzerland will require an authorized representative in Switzerland (or CH-REP). In accordance with Article 104a of the MedDO, Swiss Reps must be appointed by a certain deadline, depending on the product: for manufacturers of Class III devices, implantable Class IIb devices and active implantable medical devices, the appointment has to be made by 31 December 2021. For manufacturers of non-implantable Class IIb devices and Class IIa devices, the appointment deadline is 31 March 2022, and manufacturers of Class I devices have to appoint a Swiss Rep by 31 July 2022.
Swiss Reps and Swiss-based importers are required to register with the Swiss Agency for Therapeutic Products, Swissmedic. After their statements are checked, applicants receive a unique Swiss ID number (CHRN = Swiss Single Registration Number). This registration must be completed within three months after the product is first placed on the market in Switzerland. Manufacturers or their Swiss Reps and importers which have placed their products on the market in Switzerland prior to 26 May 2021 are required to register with Swissmedic by 26 November 2021 in accordance with Article 104b of the MedDO.
Registration of the actual medical devices imported into Switzerland is not planned until later.
Turkey, on the other hand, is no longer considered to be a third country with regard to the MDR as of 25 May 2021, since the EU has extended its customs union with Turkey to include medical devices. At the same time, Turkey has adopted the provisions of the MDR into its national law, so that manufacturers of medical devices and importers engaged in exporting medical devices to or from Turkey will not be required to meet any requirements other than those of the MDR.
Recommendation:
Under these new conditions, European distributors of medical devices which are manufactured in Switzerland may become importers (against their will) and will therefore have to adhere to the legal requirements for importers of medical devices. European manufacturers of medical devices which distribute their products in Switzerland should make sure to find and mandate a Swiss Rep before the applicable appointment deadline. At the same time, Swiss medical device manufacturers are required to have an EU authorized representative as of 26 May 2021 insofar as they distribute their products in the EU.
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