This updated guidance provides comprehensive insights into the standards in the medical devices sector, aligning with EU legislation requirements such as Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It explains how harmonized European standards, when referenced in the Official Journal of the EU (OJEU), offer a presumption of conformity with legal requirements, and details the development process for these standards, including assessment by Harmonized Standards (HAS) consultants and publication in the Official Journal of the European Union (OJEU). 

The document elaborates on the concept of “state of the art” in relation to standards, discusses relevant rulings by the Court of Justice of the EU on standardization issues, and highlights the role of European Pharmacopoeia monographs and common specifications within the regulatory framework. It describes the governance structure for standards in the medical devices sector, including the MDCG Subgroup on Standards and the CEN-CENELEC Sector Forum on Healthcare Standards, emphasizing that the use of standards is generally voluntary, with some exceptions.

Additionally, it provides numerous references and sources of information on medical device regulations and standardization. Overall, this guidance aims to clarify the intricate relationship between standards, regulations, and conformity assessment in the EU’s medical device sector.

What does it means to you?

MDCG 2021-05 Revision 1 covers comprehensive insights into various standardization aspects within the medical devices sector.