The European Commission has published in the Official Journal of the European Union (OJEU) the Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council (OJ L 256, 19.7.2021, p. 100). This document contains five references of EN ISO harmonised standards related to the currently applicable regulation on medical devices. In this sense, please note that this list of references is to be regularly enlarged and updated, according to the development of the standardization agencies both at the Internal and European level. Therefore, the new proposals on this field are expected to come from both CEN and CENELEC in about 3 months time.
Additionally, today 20th of July 2021 the Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 258, 20.7.2021, p. 50–52) has been published. This CID states on its Annex four references of EN ISO harmonised standards, similar as the previous CID but excluding of EN ISO 10993-23:2021.
Thus, these harmonised standards are ready to be accessed by you in order to presume conformity to the legal requirements they cover.
Image 1: References to harmonised standards - MDR
Image 2: References to harmonised standards - IVDR
Both implementing regulations are available in our Library – STANDARDS.