In brief

On 29 March 2023, the Swiss Federal Council, the executive body of Switzerland, announced its decision to implement an extension of the transitional periods for the certification of medical devices under the Swiss Medical Device Ordinance (“MedDO“) and the Ordinance on In Vitro Diagnostic Medical Devices (“IvDO“), in line with the amendment of transitional provisions in the European Union under Regulation (EU) 2023/607.

The implementation of these amended transitional provisions requires the formal amendment of the MedDO and the IvDO. These amendments are expected to be adopted in autumn 2023.

As a provisional measure, Swissmedic (the Swiss Agency for Therapeutic Products), which is responsible for the enforcement of Swiss medical device law, has in the meantime announced that until such time the amendments to the MedDO and the IvDO enter into force, Swissmedic will tolerate the placing of medical devices that are covered by a valid certificate pursuant to Regulations (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) on the Swiss market. This measure is aimed at preventing discrepancies in market supply conditions between Switzerland and the EU and to safeguard medical device supply in Switzerland.

Key takeaways

• The Federal Council has announced the further alignment of Swiss medical device law with EU medical device law, by way of extension of transitional periods for the certification of medical devices under the MedDO and IvDO in line with an extension implemented in the EU by way of the Regulation (EU) 2023/607. It is expected that the necessary amendments of the MedDO and IvDO will be adopted in the fall of 2023.
• Swissmedic has announced that until these amendments are adopted, it will tolerate the placing of medical devices which are covered by a valid certificate pursuant to MDR and IVDR on the Swiss market to prevent discrepancies in market supply conditions between Switzerland and the EU.

Extension of transitional periods and further alignment with EU medical device law

With the implementation of the revised MedDO of 1 July 2020 and the IvDO of 4 May 2022, Swiss medical device law was comprehensively revised following the model of the revised medical device law of the European Union under the MDR and IVDR. As a result, even after the lapse of the Mutual Recognitions Agreement between the EU and Switzerland (MDR) as of 26 May 2021, Swiss medical device law remains largely aligned with EU medical device law. 

In response to the realization that it would not be possible to achieve the necessary certification of medical devices by the expiration of the deadlines originally set out in the MDR and IVDR, the European Parliament and the Council enacted Regulation (EU) 2023/607 on 15 March 2023 with immediate effect to extend the original transitional periods and to abolish sell-off deadlines for legacy devices.

For Switzerland, too, it has become apparent that the current transition periods of the MedDO and the IvDO do not provide sufficient time to carry out the necessary certifications. The MedDO’s and IvDO’s transitional provisions stipulate the following on the validity of certificates issued under the old legislation:

Pursuant to Art. 100 of MedDO: “Certificates issued under the old legislation prior to 25 May 2017 retain their validity until the expiry date stated therein, but no longer than 26 May 2022 (para. 1),” and “certificates issued under the old legislation since 25 May 2017 retain their validity until the expiry date stipulated therein, but no longer than 26 May 2024 (para. 2).” Similarly, Art. 81 of the IvDO states: “Certificates issued under the old legislation retain their validity until the expiry date stated therein, but no longer than 26 May 2025.”

To guarantee the supply of medical devices for patients in Switzerland and to achieve further alignment with the EU medical device legislation, the Federal Council has therefore decided to adopt the provisions of Regulation (EU) 2023/607 and to amend the MedDO and IvDO accordingly. It is expected that the necessary amendments to the two ordinances will be adopted in the fall of 2023. It remains to be seen how the extension of the transition periods will ultimately be structured.

In the meantime, Swissmedic has announced that until the amendments to the MedDO and the IvDO enter into force, the placing of medical devices that are covered by a valid certificate under MDR and IVDR on the Swiss market will be tolerated by Swissmedic. This transitional measure is aimed at preventing discrepancies in market supply conditions between Switzerland and the EU until the amended transitional periods have been formally adopted.