ARTICLE SUMMARY:
The EU adds an extra round to its ongoing “scientific advice” pilot for high-risk devices. Excerpted from Pathways’ Picks April 2: EU Advice Pilot Extends, NTAP Watch, FDA Standards Scheme Starts Small.
The European Commission is extending its ongoing "scientific advice" pilot for high-risk devices to a third phase, according to an update on the Commission’s website. It sets a new June 30 deadline for companies to apply to participate in the program where expert panels provide feedback on clinical study plans to support EU Medical Device Regulation submissions. The Commission has already selected about 10 companies to participate in the first two originally planned phases. The website posting mentions a new potential feature for the third phase, where “applicants can indicate if they would be willing to have an HTA body observe their project.” This would link the effort to the EU’s Health Technology Assessment Regulation, which will implement EU-wide HTA reviews starting in 2025. One organization type that has still not been invited to participate in the pilot is notified bodies. This has grown into a source of frustration as NBs are the ones that ultimately need to review the MDR device data to support certification. (See “Can We Talk? Breaking Down Barriers to Notified Body-Manufacturer Dialogue, ”Market Pathways, December 4, 2023.)
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