Stop The Clock: MedTech Europe Says IVDR, MDR Deadlines Won't Work
Given the slow progress in implementing the new EU medtech regulations, industry group MedTech Europe is seeking urgent talks with the EU institutions and affected stakeholders to delay deadlines.
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Industry has been speculating on what exactly the European Commission intended with the various deadlines it set in the EU Medical Device and IVD Regulations. In new documents, the Commission explains what manufacturers can do and when.
New survey results suggest there could be a drop of about 40% in the number of EU notified bodies testing medical devices. A rough calculation points to an even bigger potential drop in the number that will be ready in time, when the Medical Device Regulation fully applies in 2020. A close look at newly available data signals the prospect for a serious bottleneck.
Many companies are pinning hopes on being able to use the EU Medical Device Regulation's four-year extension period for products CE marked under the current directives. But with a lack of clarity from the policymakers so far, TEAM-NB has stepped in.