The initial transition periods foreseen by the Medical Devices Regulation (MDR) for legacy devices were proved to be too short for the industry’s preparedness. To avoid a shortage of medical devices in the EU and give manufacturers more time to prepare, the Council and the European Commission spoke in favour of a longer transition period and extended certificates’ validity according to a risk-based approach. After the Proposal’s adoption and the European Parliament’s vote, the Council of the European Union approved the new transitional provisions on 7 March 2023.
Switzerland to align with new transitional provisions
Like many other countries, Switzerland is not able to independently manufacture the full range of medical products it requires. Thus, it is crucial to facilitate the import of non-Swiss medical devices into the country.
In this context, the Federal Council stated that they aim to ensure the continuous supply of medical devices and maintain equivalence between the Swiss and EU legislation. The Swiss Federal Office of Public Health has recently stated that Switzerland will adapt the Medical Devices Ordinance (MedDO) in autumn 2023 to align with the new EU extensions upon Federal Council’s adoption.
Following the newly officialised transitional provisions in the EU, the Swiss Authority might publish news on the transitional period’s implementation within March 2023.
Common approach towards certification gaps
In December 2022, the Medical Device Coordination Group published MDCG 2022-18, a guidance document on a common approach to grant derogations in case of expired certificates. Specifically, the MDCG Guidance describes how Competent Authorities could proceed to grant derogations under Art. 97 to devices whose certificates issued under the Directives expire before the new MDR certificate.
In January 2023, Swissmedic, the Swiss Agency for Therapeutic Products, published a paper on the application of MDCG 2022-18 in Switzerland. To avoid potential shortages of medical devices, Switzerland will recognize the written communication issued by a EU Competent Authority granting a period of grace under MDCG 2022-18. In case there is no written communication from an EU Competent Authority, the request for a derogation to the Swiss Competent Authority should follow the MDCG 2022-18 Guidance.
Simona Varrella
Publications Department
13/03/2023
Are you interested in selling your medical devices in Switzerland? Obelis can act as your Swiss Authorised Representative and turn your Swiss journey into a success story! Contact us today.
References:
Federal Office of Public Health. (2023). Medical devices legislation. Retrieved on 13/03/2023.
The information contained on obelis.ch is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.