The latest announcement of the European Commission aims to alleviate some of the legal uncertainty surrounding EU market access of Swiss medical devices after the date of application of the MDR in May 2021. To mitigate supply disruptions on the EU market, the EU proposes a limited modification to the current Mutual Recognition Agreement, which would grant certificates issued by a Swiss NB the same grace period the MDR grants to certificates issued in the EU.
Once accepted by both parties, this amendment could enter into force on 26 May 2021. The detailed wording of the amendment is not known yet, and the impact has to be analysed once the amendment is available. But the EU Commission emphasizes that this amendment does not include new certificates issued under the MDR. The MRA will only be updated to include the MDR once substantial progress is made on the Swiss side towards signing the Institutional Framework Agreement.
This proposed amendment to the MRA does not change the condition that third country requirements will apply as of 26 May 2021. Swiss manufacturers should continue their preparation to comply with third country requirements for products to be placed on the EU market, namely appoint an authorized representative in the EU or EEA and accordingly adapt the labelling of the products.