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Why does an Importer/Distributor need to appoint a Notified Body?
Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR.
This provided some surprises. So now in certain circumstances, some importers or distributors will need a Notified Body for their products.
Erik Vollebregt from Axon Lawyers will explain to us those cases and why this is important that importers and distributors are becoming on the scope of the authorities. If you have more questions on the topic, please send us a message as there are maybe some situations we didn’t discuss in this episode.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and…
The skinny
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