Tuttlingen – On what basis will economic relations between the EU and Switzerland stand in the future? A decision is expected before the end of this month, which will also and especially have far-reaching consequences for the medical technology industry. At an online MedTalk as part of the Med Alliance BW on May 31, Dr. Daniel Delfosse (Swiss Medtech) and Beni Hirt (Decomplix AG) the current developments and prospects.
Brussels and Bern have been struggling for a long time to reach an agreement that includes updating the Mutual Recognition Agreement (MRA) and thus the mutual recognition of conformity assessments. The current status is that no agreement has been reached and Switzerland will become a third country from May 26th, with the binding application of the EU MDR - with all the resulting requirements for the movement of goods. The regulatory framework to be expected is presented by Dr. Daniel Delfosse, Head of Regulatory Affairs at the Swiss Medtech industry association. Both the requirements for Swiss companies in the EU internal market and the challenges for companies from the EU in the federal economic area are explained. What applies to both sides in the “worst case”: Medical technology companies need an authorized representative in their target markets. Beni Hirt from Decomplix AG shows which requirements have to be met by manufacturers exporting to Switzerland and which specifications have to be observed - be it in the case of their own branches, subsidiaries or the commissioning of a service provider.
With the Med Alliance BW, MedicalMountains GmbH is building a nationwide expert initiative for the joint implementation of regulatory requirements in medical technology. The approach is that the companies involved exchange ideas on an equal footing, identify common issues with regulations, standards and laws and work out solutions together - based on their own practical experience for direct practical use. A working group has also been formed on the topics of "Switzerland/EU" and Brexit in order to design pragmatic support offers and provide assistance.
