EMA to launch scientific advice pilot for high-risk devices in late February

Regulatory NewsRegulatory News | 07 February 2023 |  By 

The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by the end of February. The pilot is part of the agency’s efforts to transition medical devices to the EU Medical Device Regulations (MDR) and streamline the path to market for such products.
EMA tentatively plans to launch an online portal on 27 February for manufacturers who want to submit letters of interest and volunteer for the scientific advice pilot program. The agency said it hopes the pilot will show how early interactions with their expert panels can help manufacturers develop better device development strategies.
“The pilot project on scientific advice to manufacturers is a very important non-legislative measure undertaken in close cooperation with the EMA Secretariat of the expert panels for medical devices, with a focus on orphan devices and [Small and Medium Enterprises] Pilot entirely funded from the EU4Health budget,” EMA said.
Under Article 61 of the MDR, manufacturers of class III and certain class IIb devices can consult with an expert panel to review their development strategy and clinical investigation proposal before they are implemented. Advice from the panel may help the manufacturer better understand what regulators require of them.
The pilot program will run through the first quarter of 2024 and will accept two batches of five applicants during that time, for a total of 10 devices. For now, the agency will not require applicants to pay a fee to participate in the pilot.
“As per Article 61(2) of Regulation (EU) 2017/745 on medical devices, the expert panels may give scientific advice to manufacturers of some high-risk medical devices on their intended clinical development strategies and proposals for clinical investigations,” EMA said. “This advice covers class III medical devices and class IIb active medical devices intended to administer or remove medicinal products from the body.”
EMA held a meeting on 25 January detailing its plans for the pilot program launch with nearly 400 remote participants. The agency noted that its expert panels have already been active in helping transition to the MDR by launching mandatory consultation procedures, including the Clinical Evaluation Consultation Procedure (CECP) in April 2021 and the Performance Evaluation Consultation Procedure (PECP) in September 2021.
With a limited number of spots available in the pilot, EMA said that the number of volunteers may exceed the expert panel's capacity. With that in mind, the panel plans to select volunteers to cover a broad spectrum of applicants, and will consider a variety of device types, medical areas, and whether the manufacturer is an SME.
EMA said it plans to announce the first round of pilot participants in April and the second round of participants in September. While companies can file letters of interest for multiple products, they will only be allowed to have one product in the pilot, and those who don't make it through the first round will automatically be qualified for the second round.
EMA also said that devices intended to benefit small groups of patients, those to address unmet medical needs and novel devices with possible major clinical or health benefits will be prioritized for the pilot program.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you