MRA between Switzerland and EU no longer valid

MRA between Switzerland and EU no longer valid

With the entry into force of MDR 2017/745 on 26.05.2021, the agreement on mutual recognition of medical devices between Switzerland and the EU lost its validity. Thus, Switzerland is now considered a “third country”, which brings significant changes for the medical device industry.

Important details about this development and its consequences can be read in the official press release of the European Union.

Ismail Demiralp

Ismail Demiralp is the Founder and Managing Director of Europe IT Consulting GmbH, based in Basel, Switzerland. He started his career as a software developer, building deep expertise in complex IT systems and regulatory-driven data architectures. Now he is building UDI solutions for MedTech companies.