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Specialist’s insight – How to tackle the changes within the transition periods of regulations?

Manufacturers who have devices CE Marked to the directives MDD, AIMDD or IVDD (i.e., legacy devices) have deadlines for regulatory compliance if they want to keep their devices on the European...

Specialist’s insight – What is the current availability of Notified Bodies?

Ever since the European Commission published the new regulations for medical and in-vitro diagnostic devices, there have been serious concerns regarding the availability of medical devices and how...

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