active implantable medical devices

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EU Regulation on e-Labeling of Medical Devices expected to enter into force end this year

On 8 June the European Commission published¬†a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities. Up to now, e-labelling was problematic and regulated in a fragmented way….

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Eudamed enters into full force

The European Database on Medical Devices (Eudamed)¬†is now finally upon us. As per article 6 of the Commission Decision establishing the Eudamed database, EU member states must apply the decision as of…

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