Regulatory Focus™ > News Articles > Questions Linger With Swiss-EU MRA and Device Regulation

Questions Linger With Swiss-EU MRA and Device Regulation

Posted 13 December 2019 | By Zachary Brennan 

Questions Linger With Swiss-EU MRA and Device Regulation

The medical device association in Switzerland and two attorneys at Sidley Austin are raising questions about the mutual recognition agreement (MRA) between the EU and Switzerland and its impact on the trade of medical devices.

Following the changes coming with the EU’s Medical Devices Regulation (MDR), Switzerland is revising its own regulations.

On 26 May 2020, MDR will take effect and according to the regulator Swissmedic, the EU regulation is currently being transposed into Swiss law and “will be applicable in Switzerland through the revised Medical Devices Ordinance (MedDO) as of spring 2020.”

The changes mean that the EU and Switzerland must revise their MRA. And the EU is trying to link the completion of another agreement’s negotiations, which would streamline the harmonization of Swiss law with EU law, with its willingness to revise the MRA.

Nicolas Lockhart and Andreas Balsiger Betts, lawyers at Sidley Austin, warned of the potential consequences of the EU’s decision regarding the EU-Switzerland MRA, “as it may entail a violation of WTO law and also constrain its ability to negotiate MRAs in the medical devices sector with other WTO Members, such as Turkey and the United Kingdom (after Brexit).”

Members of the European Commission, Swiss Medtech also wrote this week, are increasingly supporting a scenario where no devices will be covered under the MRA from May 2020.

In terms of the four years of relief provided to up-classified devices that would now need notified bodies under MDR, as part of a proposed second corrigendum, Swiss Medtech said the corrigendum “does not alleviate the situation regarding third country requirements.”

Meeting third country requirements to export products to the EU in accordance with MDR would mean designating a representative in the EU and adapting product labels. “Notified Bodies are already demanding that Swiss manufacturers prove compliance with third countries requirements,” the group said. Last summer, a Swiss notified body decided against pursuing designation under MDR.

Moving forward, Swiss Medtech said it foresees three potential scenarios for the MRA: “(1) all medical devices are covered (best case), (2) MDR products are not covered, (3) no medical devices are covered; including both MDR products as well as products with a certificate issued under the old MDD regulation (worst case).”

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