New Reasons Not To Use EU MDR's Four-Year Extension, But Comply Earlier Or Retire Products Instead
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With the current regulatory uncertainty in the EU, some companies are having trouble moving forward. Planning has become a nightmare and many don't know what to do for certain, says notified body veteran Gert Bos in the second of a two-part Q&A.
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.
In responding to industry’s plea for more time to comply with the EU’s MDR, the European Commission’s proposed one-year delay may also create some unwelcome repercussions for manufacturers and notified bodies.