EU regulatory authorities are starting to take action to prevent hundreds of products from being unnecessarily withdrawn from the EU market following the exit of notified bodies from the medtech sector. But will this practical solution mean some CE-marked products will be floating freely around Europe with no notified body backstop?
An increasing number of EU notified bodies are ceasing operations or having their scope restricted in the medtech space due to either a lack of resources to manage the increasingly tight requirements, or because they have failed assessments and have been "denotified."
But what is happening to the products for which these notified bodies have granted certificates? Are they allowed to remain...
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