On 27 February 2023, the EMA launched a program that will allow 10 manufacturers of certain high-risk medical devices and in vitro diagnostic medical devices (“IVDs”) to receive advice on their clinical development strategies from expert panels established in accordance with the Medical Device Regulation (EU) No. 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Device Regulation (EU) No. 2017/746 (“IVDR”). The aim of the program is to support developers of medical devices and IVDs in conformity assessment activities with notified bodies. The pilot phase of the program is intended to permit the EMA to gain the necessary experience to fully operationalize the ad hoc expert panel advice procedure foreseen in Article 61.2 MDR.
Articles 106 MDR and 48.6 IVDR require the European Commission to establish expert panels responsible for providing scientific, technical and clinical support in relation to the development of medical devices and IVDs to a range of stakeholders, including medical device and IVD manufacturers. Article 61.2 MDR allows manufactures of certain high-risk medical devices to seek advice from these expert panels regarding their intended clinical development strategy and proposed clinical investigations. Although this advice is subject to the payment of a fee[1], a related waiver will be provided to the 10 successful applicants participating in the pilot program. This is because the program is fully funded by the EU4Health budget.
Devices that are eligible for expert panel advice during the initial phase of the program are Class III and Class IIb devices that are intended to administer or remove medicinal products from the human body. However, only medical device manufacturers established in the European Economic Area (“EEA”) will be permitted to seek participation in the pilot phase of the program. Priority will be given to applications concerning:
- orphan devices;
- devices intended for paediatric use;
- devices addressing life-threatening medical conditions for which limited alternatives are available; or
- novel devices that have the potential for major clinical impact.
Special consideration will also be given to applications submitted by small and medium enterprises (“SMEs”).
An important factor in the selection process for participation in the pilot program will be the ability of medical device manufacturers to provide evidence in their letters of interest demonstrating that they meet the eligibility criteria. For example, manufacturers of devices intended for small patient population groups (e.g., orphan and pediatric devices) should provide a description and estimated size of their target patient population.
After the selection process has been completed, manufacturers will participate in a pre-submission meeting with the relevant expert panel to discuss their draft submission. A second meeting will follow to ensure that any remaining questions from the expert panel have been addressed by the applicants before the final request for advice is submitted. Successful applicants are expected to submit the final advice request within one month after the pre-submission meeting takes place. The expert panel will require 60 days, on average, to respond to the questions included in the advice request.
While manufacturers are not obliged to request expert panel advice, those that choose to do so must “give due consideration to the views expressed by the expert panel” by taking additional steps to align their clinical development strategies with the expert panel’s advice. Manufacturers must also ensure that the panel’s views are reflected in the clinical evaluation report allowing notified bodies to be aware of the expert panel’s advice and the manner in which manufacturers considered this advice in their clinical development strategies or clinical investigations.
The pilot program will run until the end of Q1 2024 and will include two phases of selection; one in April 2023, and one in September 2023. Medical device manufacturers can submit a letter of interest until the end of August 2023 based on the template published by the EMA.
This blog was authored by Elizabeth Anne Wright and Anastasia Vernikou.
[1] Article 106 MDR. The price of the fee is yet to be determined through an implementing act of the European Commission.
