New Reasons Not To Use EU MDR's Four-Year Extension, But Comply Earlier Or Retire Products Instead
The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.
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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.
It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.