Pathways' Pick of the Week: EMA Launches Advice Pilot For Firms Seeking MDR Approval

ARTICLE SUMMARY:

Voluntary advice pilot aimed at facilitating MDR assessment. Excerpted from Pathways’ Picks, EU Experts, CMS Contract, FDA-Apple Meeting, and More.

The European Medicines Agency will launch a year-long pilot next month to give 10 makers of innovative devices the opportunity to receive early scientific feedback from EU expert panels on clinical trial planning.

The goal is to facilitate the EU Medical Device Regulation assessment process for novel, high-risk devices, with some priority for small medtech firms.

EU officials discussed the pilot during a January 25 session and companies will be able to start submitting letters of interest to participate in the European Medicines Agency scientific advice?pilot, on February 27.

The pilot will be conducted in two phases through the first quarter of 2024, with the hope that it will provide a foundation for launching a full program sometime later that year.

It will leverage the 10?clinical specialty-focused expert panels?that have already been established as part of implementation of the MDR. The regulation requires the panels to provide opinions on notified body conformity assessments for select high-risk, novel devices, but the MDR also stipulates the panels should be used to provide early advice to developers of innovative devices to help avoid challenges later in the CE marking process. The new EMA pilot is the first step to getting those efforts off the ground.

In the pilot, the advice would typically be provided before a firm initiates a clinical study. The feedback will be based off of a series of freeform questions and proposed answers that the company submits about its clinical development plans.

Importantly, the manufacturer will not be locked into to following the advice and a notified body will not be committed to relying on the recommendations in its conformity assessment. But companies will be expected to disclose the advice in documentation submitted to the notified body.

Devices will be accepted into the pilot based on a letter of interest; the manufacturer will then participate in a pre-submissions meeting with the relevant expert panel to help formulate detailed questions and answers to be included in a full application.

The panel will then take approximately 60 days to generate the advice and will engage in another meeting with the company to make any last clarifications before delivering its final report.

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