The Official Journal of the European Union (re-)published the harmonized standard lists for AIMD, MDD and IVD Directives.
Official Journal of the European Union, L 090I, 25 March 2020
Please note Article 3:
[…] The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745 […]
Initiation of the process for harmonization of a standard with the Regulations, requires a standardization request to be agreed between the European Commission and the European Standards organizations – CEN and CENELEC.
A draft of this standardization request for MDR/IVDR was published by the European Commission on June 2019 and is currently in progress.
List of Standards to be harmonized with MDR/IVDR
#Evnia_Tips
- If/When you claim compliance with a Standard, your NB will ask you to justify why you have chosen to use this particular version (i.e. either a MDD/IVD harmonized version or a more recent version that could potentially be non-harmonized to neither MDD/IVD nor MDR/IVDR). The justification will most probably require a gap analysis and cross references to GSPRs of MDR/IVDR.
- Latest version of ISO 14971-Standard on Application of Risk Management to Medical Devices (ISO 14971:2019) is NOT harmonized to MDR. It is considered as State of the Art but relevant publication to the Official Journal of the European Union is still pending! (see Art.8 of MDR)
