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. As soon as it has done so, links will be provided on this page.

Implementing acts can be accessed via the following link:

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.
 
Art. 17 para. 4 MedDO Delegated act in accordance with Art. 27 para. 10 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.)
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.)