The EU has approval to adopt and list standards that will be recognised under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR). The legal basis is now operational for the EU to begin publication in the Official Journal of the European Union of references of harmonised standards in the context of the MDR and IVDR, which are valid on 26 May this and next year, respectively.
The EU standards organisations, CEN and Cenelec, consented to the European Commission’s mandate to revise about 200 existing standards that had been listed under the current medical devices directives and draft 27 new standards to give support to the implementation of the new regulations. This is a crucial step as harmonised standards are an important means to demonstrate conformity with the MDR and IVDR general safety and performance requirements.
Sources: Medtech Insight (an Informa product)