Applicable EU legal acts, harmonised standards and common specifications
EU legal acts can be adopted in Switzerland via different mechanisms.
Publication in the Federal Gazette:
Common specifications and harmonised standards become applicable in Switzerland after they have been designated by Swissmedic, and their references are published in the Federal Gazette - see also Standards and common specifications.
Adoption by the Federal Department of Home Affairs (FDHA):
The FDHA may amend Annexes 1-3 and 5-6 of the MedDO (Art. 93 MedDO) and Annexes 1, 2 and 4 of the IvDO (Art. 74 IvDO) following international or technical developments. This includes changes in connection with the classification according to Art. 15 MedDO by the adoption of corresponding implementing acts in Annex 5a MedDO.
Link to Fedlex for MedDO (812.213) and for IvDO (812.219)
Declaration by the Federal Council (for legislative acts with a regulatory character):
Annex 4 MedDO and Annex 3 IvDO list the EU Commission provisions under which delegated and implementing acts may be adopted; those acts, in the versions binding for EU Member States, can be declared applicable in Switzerland under Art. 82 para. 3 Therapeutic Products Act (TPA; SR 812.21). The Federal Council may declare such future implementing and delegated acts under Regulation (EU) 2017/745 on medical devices (EU-MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU-IVDR) applicable in Switzerland. The Annexes therefore need to be updated only if the underlying EU regulations are amended.
Information on the direct application of technical or administrative acts:
The implementing and delegated acts of the European Commission, which are declared by the Federal Council as directly applicable, relate to technical or administrative details that are regulated on an ongoing basis and generally amended on short notice. A total of sixteen delegated act provisions and one implementing act provision referenced in the MedDO and IvDO are thus directly applicable in Switzerland through this mechanism.
Swissmedic publishes these acts on its website in accordance with Art. 94 MedDO and Art. 75 IvDO.
Acts of the European Commission based on the EU-MDR
Subject matter |
Passed by the European Commission based on the EU-MDR |
References to directly applicable legal acts |
Art. 4 para. 2 MedDO |
Delegated act in accordance with Art. 3 - Amendment of certain definitions: nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 |
No act issued. |
Art. 17 para. 4 MedDO |
Delegated acts in accordance with Art. 27 para. 10 - Unique Device Identification: a) list of information set out in Part B of Annex VI b) amending Annex VI |
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses, last amended by Commission Delegated Regulation (EU) 2025/788, OJ L, 2025/788, 28.7.2025 Commission Delegated Regulation (EU) 2025/1920 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles |
Art. 19, para. 1 let. c MedDO |
Implementing acts in accordance with Art. 42 para. 13 - Designation and notification procedure: a list of codes and corresponding types of devices |
Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council |
Art. 20 para. 1 MedDO |
Delegated act in accordance with Art. 18 para. 3 - Implant card and information to be supplied to the patient with an implanted device |
No act issued. |
Art. 23 MedDO |
Delegated act in accordance with Art. 52 para. 5 - Conformity assessment procedures: to amend the list of well-established technologies by adding other types of class IIb implantable devices to that list or removing devices therefrom |
|
Art. 25 para. 3 MedDO |
Delegated act in accordance with Art. 56 para. 6 - Certificates of conformity: amending the minimum content of the certificates set out in Annex XII |
No act issued. |
Art. 29 para. 2 MedDO |
Delegated act in accordance with Art. 19 para. 4 - EU declaration of conformity: amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress |
No act issued. |
Art. 45 para. 2 MedDO |
Delegated act in accordance with Art. 44 para. 11 - Monitoring and re-assessment of notified bodies: to modify the frequency at which the complete re-assessment is to be carried out. |
Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies |
Art. 46 para. 3 MedDO |
Delegated act in accordance with Art. 61 para. 8 - Clinical evaluation: to amend the list of exempted devices referred to in the second subparagraph of Article 52(4) and in point (b) of paragraph 6 of this Article [Art. 61] |
No act issued. |
Art. 47 para. 1 MedDO |
Delegated act in accordance with Art. 10 para. 4 - General obligations of manufacturers – amending the Annexes II and III, in the light of technical progress |
No act issued. |
| Art. 98 para. 2 let. b MedDO |
Delegated act in accordance with Art. 106 para. 15: Provision of scientific, technical and clinical opinions and advice: - tasks of expert panels and expert laboratories |
No act issued. |
Delegated Acts of the European Commission based on the EU-IVDR
Subject matter |
Passed by the European Commission based on the EU-IVDR |
References to directly applicable legal acts |
Art. 16 para. 4 IvDO |
Delegated act in accordance with Article 24 paragraph 10 - Unique Device Identification system: a) list of information set out in Part B of Annex VI b) amending Annex VI |
No act issued. |
Art. 21 para. 3 IvDO |
Delegated act in accordance with Art. 51 para. 6 - Certificates of conformity: amending the minimum content of the certificates set out in Annex XII |
No act issued. |
Art. 25 para. 2 IvDO |
Delegated act in accordance with Art. 17 para. 4 - EU declaration of conformity: amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress |
No act issued. |
Art. 38 para. 2 IvDO |
Delegated act in accordance with Art. 40 para. 11 - Monitoring and re-assessment of notified bodies: to modify the frequency at which the complete re-assessment is to be carried out. |
Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies |
Art. 40 para. 1 IvDO |
Delegated act in accordance with Art. 10 para. 4 - General obligations of manufacturers: amending, in the light of technical progress, the Annexes II and III |
No act issued. |
Art. 58 IvDO |
Implementing act in accordance with Art. 24 para. 11 let. a – Unique Device Identification system: a) determining the devices, categories or groups of devices to which the obligation to store and keep the UDI for devices which they have supplied or with which they have been supplied is to apply. |
No act issued. |
Commission delegated acts can be accessed via the following links:
Non-legislative acts:
By contrast, implementing acts that do not have a legislative character are considered in the context of enforcement (Art. 95 paragraph 1 MedDO and Art. 76 IvDO).
Implementing acts adopted by the EU Commission can be accessed via the following links:
The regulations (EU) 207/2012 and 722/2012, adopted under the MDD, continue to apply in the versions listed in Annex 3 MedDO, pursuant to Article 95 paragraph 2 MedDO, until they are repealed by implementing acts adopted by the EU Commission on the basis of the EU-MDR.
