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First Harmonized Standards Published For Both MDR And IVDR

 
• By Amanda Maxwell

After a long delay, the EU’s first harmonized standards under the MDR and IVDR are trickling through ̶ but the standards situation is still far from ideal.

Standards

The first publication in the Official Journal of the EU of references of harmonized standards in the context of the Medical Device Regulation took place on 19 July, and those in the context of the IVD Regulation, on 20 July. They were published by means of European Commission implementing decisions.

If a standard is harmonized, then it can be used by manufacturers to demonstrate compliance with the General Safety and Performance Requirements in the new regulations.

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