Pulmonary Valve, Hip Device Under the Microscope in Latest EU Panel Opinions

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ARTICLE SUMMARY:

Two new MDR expert panel opinions were published by the EU this week. It also reposted the first MDR panel opinion that had been placed online and then taken down over the summer. The clinical consultations offer a window into the extra scrutiny that high-risk devices are subject to under the new regulations.

Developers of new high-risk implantable devices or active devices that deliver a medicine now have three EU expert panel consultations to help inform their CE mark clinical evaluation efforts. The European Commission has posted two new Clinical Evaluation Consultation Procedure (CECP) opinions in the past week, and it also reposted one that it previously took offline.

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