eu mdr

Borderline products remain one of the trickiest challenges under the EU Medical Device Regulation (EU) MDR 2017/745 and the In Vitro Diagnostic Regulation (EU) IVDR 2017/746.

This blog discusses the current status of the role of the PRRC sharing key takeaways from a free webinar Comply Guru ran and is available on demand on our website.

While the EU Medical Device Regulation (MDR) brings numerous improvements, it also poses several challenges that need to be addressed. In this blog, I discuss five of the challenges under the European Medical Device Regulation.