EMA Launches Pilot Program For Expert Panel Scientific Advice In Relation To Certain High-risk Devices

• Jurisdiction: European Union
• Law Firm: Cooley LLP
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Author: Ms Elizabeth ann Wright and Anastasia Vernikou
• Published date: 13 March 2023

Ten medical device and IVD developers will receive free advice on their clinical development strategies from medical device expert panels. The pilot program aims to help EMA with the implementation of the expert panel advice procedure established in MDR and IVDR.

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 fee¹, 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...