EU MDR Standards Delay: MedTech Europe Offers A Pragmatic Way Forward
Standards harmonized under the EU medical device directives may have more longevity than originally expected, given the delay in the readiness of standards that can be used in the context of the forthcoming Medical Device Regulation.
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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.
The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”
The European Commission has at last officially requested that CEN and CENELEC develop and update urgently needed standards to support the MDR and IVDR. The pressure is now on the national European standards bodies to press on with the necessary work.