EMA’s advice pilot welcomed by high-risk device manufacturers

BRUSSELS – There has been good response to a pilot program set up by the European Medicines Agency (EMA) in which its expert panels give scientific advice directly to manufacturers of high-risk medical devices, Silvy da Rocha Dias, head of the EMA’s Office of Expert Panels and Groups, told attendees at the 2023 RAPS European Clinical and Risk Management Conference.

The pilot, which was launched in February 2023, invited manufacturers of class III medical devices and class IIb active medical devices intended to administer or remove medicinal products from the body, and that are based in the European Economic Area (EEA) to submit “letters of interest” to be considered for participation (RELATED: EMA to launch scientific advice pilot for high-risk devices in late February, Regulatory Focus 07 February 2023).

EMA received 41 letters of interest, according to da Rocha Dias. The majority (65%) of letters came from small and medium-sized enterprises (SMEs), most within circulatory (39%), orthopedic (27%) or neurological (17%) specialties. Additionally, 12% of manufacturers who submitted letters work within the areas of general or plastic surgery and dentistry, 3% within nephrology and urology, and the remaining 2% within gastroenterology and hepatology.

The aim of the pilot program is to provide specific advice “intended for the clinical development strategies and the proposals for clinical investigations,” da Rocha Dias said. For this reason, the advice given is purely clinical, she added.

The pilot program runs alongside the expert panels’ other mandatory commitments, which include checking selected Clinical Evaluation Assessment Reports (CEAR) and Performance Evaluation Reports (PER) produced by Notified Bodies via processes known as the Clinical Evaluation Consultation Procedure (CECP) and Performance Evaluation Consultation Procedure (PECP). As such, only a few of the manufacturers that have expressed an interest in the pilot program will be invited to join.

Manufacturers will be selected for the pilot based on whether the device is intended to benefit a small group of patients, such as orphan or pediatric devices; if the device addresses an unmet medical need or meets criteria as a breakthrough device; or if it is a novel device with a possible major clinical or health impact.

“What we are looking for is to try to have as many different [clinical] areas of the panels, as well as different types of devices that will be represented in this pilot,” da Rocha Dias said.

To date, six manufacturers have been accepted into the pilot program, with an additional 33 manufacturers under consideration. “We are contacting those manufacturers and having exploratory meetings initially to see how ready those manufacturers are for the advice,” da Rocha Dias said.

That means that the manufacturers already have some idea of what their clinical development plan looks like, or have proposals for clinical investigations, she said. The manufacturers may have thought about how they are going to evaluate the benefits versus risks but may still have questions on how to substantiate their claims or select the best endpoints.

Many of the letters of interest received have been for novel or breakthrough devices (48%), 31% address an unmet need and 21% relate to a small patient population. The letters cover different phases of device development, from first-in-human pilot studies to pivotal studies, with some manufacturers having a full clinical strategy that includes study designs and plans for post-market clinical follow up and others seeking advice about ongoing studies.

Other notable changes regarding the expert panels will be published soon on the EMA website, da Rocha Dias said, including changes regarding the instruction to Notified Bodies for the CECP and PECP and how those opinions are published.

“Since [the expert panels] have been transferred to the EMA, we have to harmonize the way that these opinions are published, and so the procedural alignment is now fully in line with EMA processes,” da Rocha Dias said.

This means that the publication of opinions will only be made once the certification process has been completed and the CE certificate has been issued, refused or withdrawn. Previously, publication was done as soon as the expert panel had provided an opinion, da Rocha Dias said. “In the absence of [the European Database on Medical Devices], we do rely on the Notified Body to let us know when the certification process is completed,” she said.

EMA’s advice pilot welcomed by high-risk device manufacturers

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