EMA official reports on scientific advice pilots for high-risk and orphan devices

BARCELONA – A European Medicines Agency (EMA) official provided an update on the agency’s pilot programs aimed delivering scientific advice to manufacturers of high-risk and orphan medical devices to support the clinical development of such products.

Alberto Gañan Jimenez, head of committees and quality assurance department at EMA, provided this update at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 23 October.

Article 61(2) of the Medical Device Regulation allows manufacturers of class III and certain class IIb active devices to consult an expert panel for input on the company’s clinical development plans. In 2022, new EU regulations expanded EMA’s mandate to require that the agency provide support to the expert panels on medical devices.

EMA first announced its pilot program for providing scientific advice to high-risk devices in February 2023, and in August 2024, announced a new pilot to offer such advice to developers or orphan medical devices. The pilot for high-risk devices is currently in its third phase, while the orphan devices pilot is slated to end in in 2025. (RELATED: EMA to launch scientific pilot for high-risk devices in late February, Regulatory Focus 7 February 2023; EMA pilot aims to advise on orphan device development, Regulatory Focus 5 August 2024)

Gañan Jimenez noted that the pilots are being conducted amid increased clinical evidence requirements for high-risk devices under MDR.

Under the pilot for high-risk devices, EMA has received requests for scientific advice for 32 applications for a novel device, 21 applications for devices that address an unmet medical need, and 13 devices addressing a small population. Most of the requests are from manufacturers of circulatory system devices and orthopedic devices. Sixty-seven percent of the companies that participated were small businesses, while 33% were large companies, Gañan Jimenez said.

For the orphan device pilot, Gañan Jimenez said the agency has received four applications. The agency has said it will accept applications through October 2024 and the pilot is expected to enroll four participants.

CECP/PECP update

Gañan Jimenez also provided updated metrics on the Clinical Evaluation Consultation Procedure (CECP) for medical devices and the Performance Evaluation Consultation Procedure (PECP) for IVDs. Notified bodies are required to follow this procedure for certain eligible devices and IVDs under their respective regulations to solicit advice from the expert panels.

Through 30 September 2024, Gañan Jimenez said that 137 CECP applications were screened, resulting in 16 opinions, seven of which were for new devices under MDR, while the remaining nine were given for modified devices that were initially certified under the former directives. Some examples of recent opinions include a transcatheter aortic heart valve, a tricuspid heart valve replacement system, an implantable pulse generator (IPG) for epilepsy, and a shoulder prosthesis.

So far, Gañan Jimenez said the expert panels have screened 21 PECP applications and issued an opinion for 20 IVDs.

Lack of clinical data on high-risk devices

Per Kjaersgaard-Andersen, an orthopedic surgeon and associate professor at South Danish University, and chair of Biomedical Alliance’s Medical Device Task Force, presented the group’s point of view on the clinical evaluation of high-risk implantable devices. Overall, he said there needs to be more information in the scientific literature on high-risk devices.

The Biomedical Alliance is an initiative of 35 European medical societies that include over 400,000 researchers and health professionals.

Kjaersgaard-Andersen cited a recent study of 71 CE-marked cardiovascular devices which found that only 9% of the studies were published before the devices were marketed, and none of the reviewed devices had a randomized trial published before being marketed. In addition, no proposed clinical trial was found for 30% of the devices in the study, and only 19% of all studies were randomized controlled trials.

He said the evidence that is publicly available from these investigations is also “insufficient to enable physicians to make informed recommendations to patients of which devices to use.”

In other areas, Kjaersgaard-Andersen also called for a comprehensive evaluation of MDR to ensure that any changes made are to the benefit of patients rather than implementing short-term legislative measures without first identifying the shortcomings in the current system.

He further recommended a reduction in costs for conformity assessment for orphan devices, pediatric devices, and some legacy medical devices, and called for “additional regulatory capacity” within the European Commission’s health department.

EMA official reports on scientific advice pilots for high-risk and orphan devices

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