Applicable EU legal acts

EU legal acts can be applied in Switzerland in different ways.

After approval by the FDHA:

The Federal Department of Home Affairs (FDHA) can adapt Annexes 1-3 and 5-6 of the MedDO to international or technical developments, e.g. in connection with the classification according to Art. 15 MedDO by the adoption of corresponding implementing acts in Annex 5a MedDO.

By publication in the Federal Gazette:

Common specifications become legally valid in Switzerland only after they have been designated by Swissmedic and published in the Federal Gazette. – see also

Direct application of acts of a technical/administrative nature:

Art. 82 para. 3 of the Federal Act on Medicinal Products and Medical Devices (TPA; SR 812.21) allows the Federal Council to declare future implementing legislation (the “implementing and delegated acts”) of the European Commission in respect of Regulation (EU) 2017/745 on medical devices (EU-MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the version currently binding for the EU member states as being applicable to Switzerland as well.

In the area of medical devices (including in vitro diagnostics), the Federal Council can only declare the implementing and delegated acts of the European Commission as directly applicable if they relate to technical or administrative details that are regulated on an ongoing basis and generally at short notice.

In Annex 4 of the Medical Devices Ordinance (MedDO, SR 812.213) and Annex 3 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), the Federal Council has declared the following legal acts of the European Commission to be directly applicable to Switzerland. As soon as it has done so, links will be provided on this page.

Implementing acts can be accessed via the following link: