The European Commission has released a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards it will seek to have revised or drafted in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
The Commission made its standardization request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) in 2021, calling on the two standards bodies to revise or draft more than 200 harmonized standards over the course of three years. (RELATED: MDR/IVDR: Commission adopts new standardization request, Regulatory Focus 16 April 2021)
The development of harmonized European standards is a major component of the new device and IVD regulations, as products developed in conformity with harmonized standards referenced in the Official Journal of the European Union (OJEU) are presumed to be in conformity with the corresponding legal requirements laid out in the MDR and IVDR…
