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BIVDA attends MedTech Europe’s Regulatory Affairs Committee

By June 17, 2022No Comments

The meeting covered a number of topics, with of course a lot of discussion on the EU IVDR which had its date of application on 26 May. Attendees were keen to celebrate such a momentous milestone for the industry as we considered the key concerns we still have going forward. This includes a major gap in information and guidance around some areas, and the obvious lack of notified bodies designated under the EU IVDR.

The new IVD priorities for MedTech Europe were agreed, which are consistent with areas BIVDA continues to work on.

It was also a chance to thank Volker Franzen (Qiagen), who has been Chair of the committee for a number of years, as he steps down from this role. Kira Meyerovich (BD) and Anna Hallersten (Roche) have now taken over as co-Chairs.

Natalie Creaney