EU: Initial report from an expert committee within the context of the consultation procedure for clinical evaluation

As part of the consultation procedure in accordance with Article 54 MDR for specific products in Class III and IIb, the EU has published the first scientific report from an expert committee.

The process stipulates that, for implantable Class III products and active Class IIb products that deliver medicinal products or remove medicinal products from the body, the notified body must present its report on the assessment of the clinical evaluation to an expert committee. This expert committee can then decide whether to create its own independents scientific report, which must then be taken into consideration by the notified body accordingly. In a specific case – a Class III bone implant – the expert committee considers the clinical data to be insufficient, partly simply because the follow-up periods were too short, and partly because clinical investigations had not been performed.