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Open The Champagne! EU Go Ahead For Standards Needed For New Medtech Regulations

 
• By Amanda Maxwell

The EU has the green light to adopt and list standards that will be recognized under the MDR and IVDR. But there will be no escaping the impact of the delays, especially for the IVD sector.

Champagne

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...

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