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Key Changes In Commission’s Latest Draft EU Standards Request To CEN/Cenelec

 
• By Amanda Maxwell

Medtech companies selling in the EU will be keeping their fingers crossed that the European standards bodies will accept this third standards request from the Commission once the document is finalized.

Time for Standards - Image

The medtech sector is going to be waiting for a long time before it has access to updated and new harmonized standards to be cited by manufacturers to demonstrate compliance with the EU’s Medical Device and IVD Regulations.

Missing Cornerstone Of EU MDR and IVDR

EU standards, while not mandatory for the medtech industry, are one of the cornerstones of EU regulation. Manufacturers may cite harmonized standards to argue they have met the Essential Requirements (ERs) of the current Medical Devices Directive. (MDD). But these ERs are being replaced by General Safety and Performance Requirements (GSPR) in the MDR.

This means all existing medical device and IVD standards have to now be updated as well as some new standards drafted and adopted, and that standards currently harmonized under the MDD will lose their harmonized status as of 26 May 2021.

This will leave the industry in a standards limbo, for some up until 2024 when the revised/new standards are due to have been adopted.

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