Delegated Acts of the European Commission based on the EU-MDR

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; version binding for the EU member states) applicable to Switzerland as well.

In the area of medical devices, 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), the Federal Council has declared the following legal acts of the European Commission to be directly applicable to Switzerland. The European Commission has not yet passed any delegated acts. As soon as it has done so, links will be provided on this page.

Implementing acts can be accessed via the following link:

Links for the implementing acts to Annex 4 (Art. 19 para. 1 let. c MedDO, Art. 42 para. 13 EU-MDR) on product codes are shown in the following table (only one so far).

Subject matter Passed by the European Commission based on the EU-MDR
Art. 4 para. 2 MedDO Delegated act in accordance with Art. 3 EU-MDR
Art. 17 para. 4 MedDO Delegated act in accordance with Art. 27 para. 10 EU-MDR
Art. 19, para. 1 let. c MedDO Delegated act in accordance with Art. 42 para. 13 EU-MDR
Art. 20 para. 1 MedDO Delegated act in accordance with Art. 18 para. 3 EU-MDR
Art. 23 MedDO Delegated act in accordance with Art. 52 para. 5 EU-MDR
Art. 25 para. 3 MedDO Delegated act in accordance with Art. 56 para. 6 EU-MDR
Art. 29 para. 2 MedDO Delegated act in accordance with Art. 19 para. 4 EU-MDR
Art. 45 para. 2 MedDO Delegated act in accordance with Art. 44 para. 11 EU-MDR
Art. 46 para. 3 MedDO Delegated act in accordance with Art. 61 para. 8 EU-MDR
Art. 47 para. 1 MedDO Delegated act in accordance with Art. 10 para. 4 EU-MDR
Art. 98 para. 2 let. b MedDO Delegated act in accordance with Art. 106 para. 15 EU-MDR