How One EU Notified Body Transitioned From The Directives To The MDR And What The Change Means For Clients

 
• By Amanda Maxwell

Less than two months after the MDR applied in the EU, GMED’s Tarik Krim explains how his notified body navigated the early phase of the transition from auditing the directives to the regulation, and how the change has impacted its clients and demand for services.

Imagination idea and transition concept as a leaf changing to a butterfly shape as a fantasy travel and amazing inspirational spirit symbol in a 3D illustration style.
Transitioning from the EU directives to the MDR

The run up to the full implementation of the EU Medical Device Regulation was a period of intense activity and change for notified bodies, which, among other things, had to seek designation against the new rules and adjust from testing against the medical device directives to the much stricter requirements of the MDR.

It has been a challenging time, not least because certain aspects of the new regulation, such as standards and the...

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