The legal basis is now in force for the EU to start publication in the Official Journal of the European Union of references of harmonized standards in the context of the Medical Device and IVD Regulations (MDR and IVDR) which apply on 26 May this year and next year respectively.
The news follows the EU standards organizations, CEN and Cenelec, accepting the European Commission’s mandate to revise some 200 existing standards that had been listed under the current medical device...