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:
Passed by the European Commission based on the EU-MDR
Passed by the European Commission based on the EU-IVDR
| Subject matter | Passed by the European Commission based on the EU-MDR | MDR Article | Delegated acts |
|---|---|---|---|
| Art. 4 para. 2 MedDO | Delegated act in accordance with Art. 3 EU-MDR | Article 3 - Amendment of certain definitions The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level. |
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| Art. 17 para. 4 MedDO | Delegated act in accordance with Art. 27 para. 10 EU-MDR
Delegated act in accordance with Art. 27 para. 10, point (b), EU-MDR |
Article 27 - Unique Device Identification system (10) The Commission is empowered to adopt delegated acts in accordance with Article 115: (a) amending the list of information set out in Part B of Annex VI in the light of technical progress; and (b) amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification. |
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (Text with EEA relevance.) 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 |
| Art. 19, para. 1 let. c MedDO |
Delegated act in accordance with Art. 42 para. 13 EU-MDR | Article 42 - Designation and notification procedure (13) The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 48. |
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 (Text with EEA relevance. ) |
| Art. 20 para. 1 MedDO | Delegated act in accordance with Art. 18 para. 3 EU-MDR | Article 18 - Implant card and information to be supplied to the patient with an implanted device (3) The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom. |
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| Art. 23 MedDO | Delegated act in accordance with Art. 52 para. 5 EU-MDR | Article 52 - Conformity assessment procedures (5) Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom. |
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| Art. 25 para. 3 MedDO | Delegated act in accordance with Art. 56 para. 6 EU-MDR | Article 56 - Certificates of conformity (6) In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the certificates set out in Annex XII. |
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| Art. 29 para. 2 MedDO |
Delegated act in accordance with Art. 19 para. 4 EU-MDR | Article 19 - EU declaration of conformity (4) The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress. |
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| Art. 45 para. 2 MedDO | Delegated act in accordance with Art. 44 para. 11 EU-MDR | Article 44 - Monitoring and re-assessment of notified bodies (11) The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph 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 (Text with EEA relevance) |
| Art. 46 para. 3 MedDO | Delegated act in accordance with Art. 61 para. 8 EU-MDR | Article 61 - Clinical evaluation (8) Where justified in view of well-established technologies, similar to those used in the exempted devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 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, by adding other types of implantable or class III devices to that list or removing devices therefrom. |
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| Art. 47 para. 1 MedDO | Delegated act in accordance with Art. 10 para. 4 EU-MDR | Article 10 - General obligations of manufacturers (4) Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III. |
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| Art. 98 para. 2 let. b MedDO | Delegated act in accordance with Art. 106 para. 15 EU-MDR | Article 106 - Provision of scientific, technical and clinical opinions and advice (15) The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the tasks of expert panels and expert laboratories referred to in paragraph 10 of this Article. |
Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices (Text with EEA relevance.) |
| Subject matter |
Passed by the European Commission based on the EU-IVDR | IVDR article wording | Implementing acts |
|---|---|---|---|
| Art. 16 para. 4 IvDO | Delegated act in accordance with Article 24 paragraph 10 EU-IVDR | Article 24 Unique Device Identification system (10) The Commission is empowered to adopt delegated acts in accordance with Article 108: a) amending the list of information set out in Part B of Annex VI in the light of technical progress; and b) amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification. |
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers in the field of medical devices (Text with EEA relevance.) |
| Art. 21 para. 3 IvDO | Delegated act in accordance with Art. 51 para. 6 EU-IVDR | Article 51 Certificates of conformity (6) In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the certificates set out in Annex XII. |
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| Art. 25 para. 2 IvDO | Delegated act in accordance with Art. 17 para. 4 EU-IVDR | Article 17 Declaration of conformity (4) The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress. |
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| Art. 38 para. 2 IvDO | Delegated act in accordance with Art. 40 para. 11 EU-IVDR | Article 40 Monitoring and re-assessment of notified bodies (11) The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that paragraph 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 (Text with EEA relevance) |
| Art. 40 para. 1 IvDO | Delegated act in accordance with Art. 10 para. 4 EU-IVDR | Article 10 General obligations of manufacturers (4) … The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress, the Annexes II and III. |
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| Art. 58 IvDO | Implementing act in accordance with Art. 24 para. 11 let. a EU-IVDR | Article 24 Unique Device Identification system (11) The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following: a) determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply [Store and keep the UDI for devices which they have supplied or with which they have been supplied….] |