Switzerland | Medical Device Regulation

What should Dutch medical device exporters know & do?

The Netherlands Embassy in Bern, Task Force Health Care and RVO are organizing a webinar on the 3^rd of February, 2022 from 10:00 – 11:00 to inform the Dutch healthcare sector on the changes in export regulations between EU countries and Switzerland.

As of May 26, 2021, Switzerland has been designated a “third country” by the European Union with regards to medical devices. Up to that date, despite not being an EU member, Switzerland has traditionally traded with the EU under a Mutual Recognition Agreement (MRA), which meant that medical devices were able to be moved in and out of the country freely. The MRA was not renewed after the adoption of the EU Medical Device Regulation (2017/745). This change will impact all medical device companies wanting to export their products or services to Switzerland. Swiss manufacturers will be treated like any other non-EU entities, and non-Swiss manufacturers will have to appoint Swiss Authorized Representatives (ARs) and importers based in Switzerland. This change affects all devices, including so-called “legacy devices,” which rely on the prior Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to maintain their certificates for some time longer. (Emergo, 2021)

In order to inform you about these changes and provide you with actionable handholds to work with, Task Force Health Care, the Netherlands Embassy in Bern and RVO are organizing a webinar.

What to expect?

• Opening
• Introduction
  By Guido Danen, TFHC & Philippe Evers, RVO
• Presentation on the Swiss Medical Device Regulation
  By Andre Breisinger, Expert Medical Device Regulation, Swissmedic (Swiss Agency for Therapeutic Products)
• Q&A with Swissmedic
• Introduction MedEnvoy
  By Edgar Kasteel, Partner & Managing Direction, MedEnvoy
• Q&A
• End