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Termination of the medical devices chapter of the Agreement on Mutual Recognition between the European Union and Switzerland


On 26 May 2021, in connection with the entry into force of the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, as amended ("MDR"), the European Commission announced the termination of the chapter on medical devices Mutual recognition agreements between the European Union and Switzerland (Mutual Recognition Agreement, (MRA)).

Swiss manufacturers are treated like any other third country manufacturer intending to place devices on the EU market. Existing certificates issued under the MRA by notified bodies in Switzerland are no longer recognised as valid as of 26 May 2021 and economic operators (affected EU manufacturers, authorised representatives, importers and distributors) as well as EU market surveillance authorities and customs authorities in the Member States are obliged to act in accordance with the MDR.