Who Can Use MDR's Four-Year Derogation Extension? Notified Bodies Try To Clarify
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.
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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.
One-Third Of SMEs To Change Notified Body; Half Believe EU MDR Deadline Extension Likely, Survey Finds
If the findings of a Swiss survey of smaller companies represent the picture around the EU in general, companies are ill-prepared for the new Medical Device Regulation, confused, and far from convinced of its value.