In recent weeks, there have been significant developments in the field of medical device regulations in Switzerland. Swissmedic, the Swiss authorization and control authority for therapeutic products, has taken measures to maintain equivalence with EU medical device regulations and ensure the supply of medical devices in the country, due to adjustments in EU regulations.
Adjustments in EU Medical Device Regulation
In March 2023, the EU made adjustments to the EU-MDR 2017/745 and the EU-IVDR 2017/746, among other things, to extend the validity of certificates under the old law until 2027/2028 and to abolish deadlines for commissioning and provision of medical devices on the market. These changes were made to avoid potential supply shortages due to delays with the designated bodies.
Swiss Adaptations to EU Regulations
As a result, the Federal Council decided that Switzerland must also implement these adjustments to avoid a possible supply shortage. Adjustments to the Medical Devices Ordinance (MepV) and the In-vitro Diagnostic Devices Ordinance (IvDV) are planned for the fall of 2023. Until then, Swissmedic will tolerate the placing on the market of products in Switzerland that are covered by a valid certificate according to the MDR and IVDR amendments within the scope of therapeutic product law enforcement.
Additionally, the Federal Council plans to make changes to the MepV and IvDV regulations in the fall of 2023 to tighten requirements for product groups without medical purpose. This primarily concerns products for cosmetic treatment and cognitive ability enhancement.
What Should Medical Device Manufacturers Consider?
For medical device manufacturers, this means that they can continue to offer their products on the Swiss market as long as they have a corresponding certificate in accordance with the EU amendments. This ensures legal certainty during the transition phase and does not create different conditions for market supply between Switzerland and the EU.
Conclusion
Actively engage with the latest changes now to meet regulatory requirements and continue to operate successfully in the market. Information on this can be found on the Swiss Agency for Therapeutic Products
https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/marktzugang/abgelaufene_bescheinigungen.html and the Federal Office of Public Health
https://www.bag.admin.ch/bag/de/home/das-bag/aktuell/medienmitteilungen.msg-id-94011.html.
Our experts are also happy to assist you personally with this issue and support you in the area of medical device regulations. Contact us to learn more about how we can help you successfully navigate the transition phase and ensure that your products continue to meet current requirements. We are also happy to assist you in obtaining approval for your products on the Swiss market.
We look forward to hearing from you!