Author: Medical Device Coordination Group
Publication date: April 2021
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745.
The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.
Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
The document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities.
The contents of the document:
1. EU legislation on medical devices within the “New Approach” and the “New Legislative Framework”
2. The general framework for harmonised European standards
2.1. Main references
2.2. Voluntary use of standards
2.3. The relationship between harmonised European standards and EU legislation: the “Annex Z”
3. Harmonised European standards in support of the EU legislation on medical devices
3.1. Legal references, European standardisation organisations and standardisation mandates or requests
3.2. Development of harmonised European standards for medical devices and assessment by the HAS consultants
3.3. Publication in the OJEU of references to harmonised European standards to confer presumption of conformity
3.4. International aspects of standardisation
3.5. The concept of “state of the art”, European standardisation and conformity assessment for medical devices 4. Governance structure for standards in the medical devices sector
4.1. The MDCG Subgroup on Standards
4.2. The CEN-Cenelec Advisory Board of Healthcare Standards (ABHS)