EMA extends scientific advice pilot for high-risk medical devices

Quick background on the expert panels and the scientific advice pilot

• The E.U. medical and diagnostic device regulations established expert panels. Both the Medical Device Regulation (MDR; Regulation (EU) 2017/745) and In Vitro Diagnostic Device Regulation (IVDR; Regulation (EU) 2017/746) outline the role of these panels to provide “scientific and expert advice, contribute guidance and other relevant documents, and to identify emerging issues of concerns regarding medical devices and [IVDs].”
• Expert panels have two main tasks under these regulations: To provide opinions/views and ad hoc advice. The panels issue opinions and views as part of “mandatory consultation procedures” outlined in both the MDR and IVDR. Certain high-risk medical devices must undergo the Clinical Evaluation Consultation Procedure (CECP) according to Article 54 of the MDR; these include class III implantable devices or class IIb active devices that “administer and/or remove a medicinal product.” Similarly, Class D (and some Class C) IVDs have to follow the Performance Evaluation Consultation Procedure (PECP), as described in Article 48(6) of the IVDR. For a fee, manufacturers can also consult with expert panels on clinical development plans and clinical investigation proposals (MDR Article 106(11)). While the medical device expert panels launched under the aegis of the European Commission, oversight was ultimately transferred to the European Medicines Agency (EMA) as part of its expanded mandate and role in emergency response.
• Expert panels and clinical development: The MDR grants manufacturers and Notified Bodies involved in the conformity assessment of high-risk medical devices the right to consult an expert panel on the “intended clinical development strategy and proposals for clinical investigation” as part of the clinical evaluation process outlined in MDR Article 61. The manufacturer is obligated to “give due consideration to the views expressed by the expert panel [and this] shall be documented in the clinical evaluation report.” Notably, the MDR allows the Commission to establish fees for provision of scientific advice by expert panels or expert laboratories through the means of implementing acts (via the examination procedure).
• In January 2023, the EMA launched a pilot of the scientific advice program, with the intention to establish the advice process and estimate the appropriate fees to charge manufacturers (pilot participants would not be charged). At the time, the agency planned to select ten projects in two rounds over the course of 2023 using three criteria: 1) the device benefits a small number of patients (orphan/pediatric devices), 2) the device addresses unmet an medical need, and 3) a novel device has the potential for major health or clinical impact. The experts also planned to prioritize applications from small and medium-sized enterprises (SMEs).
• Six applicants were chosen for phase one. The EMA reported at the Fifth Industry Standing Group (ISG) meeting in late June 2023 that the experts ultimately chose six projects for the first phase after receiving 26 letters of interest. The expert panels covered by the applications included the circulatory system panel, orthopedics, neurology, and dentistry; just over 30% were from SMEs. Eight submissions addressed small patient populations, 16 addressed unmet medical needs, and 24 were for novel devices (each individual submission could fall under more than one of these categories). The phases of development were first-in-human and pilot studies, pivotal studies, the full clinical strategy (pre- and post-market), and advice on ongoing studies.

Now, the EMA is asking for more applications

• Via an update to its website, the EMA has added a new call for applications to the pilot. This third phase of the pilot will be open through June 30, 2024. Manufacturers or their authorized representatives can use the application form (requires login) to apply for participation. The EMA also notes that for the third phase, “applicants can indicate if they would be willing to have an HTA [Health Technology Assessment] body observe their project. In such cases, EMA will inform them whether this will be possible.” The EMA directs any questions on the pilot to the expert panel secretariat.
• The expert panels will prioritize “applications that can cover varied medical areas and device types.” Considering that the first six chosen applications covered the circulatory system, orthopedics, neurology, and dentistry, this suggests that other clinical areas with different expert panels may have a higher likelihood of selection. These may include respiratory systems, endocrinology, obstetrics and gynecology, gastroenterology and hepatology, nephrology and urology, or ophthalmology.
• Reminder: Pilot advice is limited to clinical development strategies and clinical investigation proposals for class III medical devices or class IIb medical devices that administer or remove medicinal products from the body. Diagnostics are excluded from the scope of the pilot.

Analysis

• It isn’t entirely clear why the scientific advice pilot has been extended into an unplanned third phase. The EMA website states that the current pilot phase “includes a limited number of scientific advice procedures,” suggesting that the expert panels may be looking to include a wider range of device types or clinical areas in the program.
• There is still no publicly available information on the status of the second phase of the pilot. For the first phase, the EMA disclosed that the expert panels chose six – rather than the originally intended five – applications. However, the webpage does not provide information on the applications chosen in the second phase. It’s also not clear if the EMA now intends to go beyond the initially planned 10 projects or whether it’s still looking to fill the original 10 slots for the pilot.
• It’s unclear from the updated webpage whether the scope of the pilot has been widened beyond the European Economic Area (EEA). In the Q&A document issued before the pilot formally began, it limited participants to the EEA, which is the EU 27 plus Iceland, Liechtenstein and Norway. The updated webpage does not explicitly contradict this; however, it does state that either the manufacturer or its authorized representative can submit an application. Given that countries in the EEA do not need to appoint authorized representatives, this update may indicate that the scope of who can apply has been widened beyond the EEA.
• The most extensive information provided by the EMA regarding the pilot has actually been delivered at its industry standing group (ISG) meetings. The agenda for the Eighth ISG meeting that took place on March 25 included an item to discuss “learning from the Expert Panels advice pilot and next steps,” but the minutes have not yet been posted. The pilot was also discussed during the September 2023 meeting. Interestingly, even in those minutes, there is no information on whether ten projects had been chosen yet. The minutes do indicate that the EMA received 41 letters of interest (up from the 26 reported at the June 2023 meeting), and those covered two additional clinical areas – nephrology and urology; gastroenterology and hepatology. As intended, the bulk (65%) of the letters of interest came from SMEs and nearly half were novel devices, with 31% addressing unmet medical needs and 21% addressing small populations.

To contact the author of this item, please email Corey Jaseph ( [email protected]).
To contact the editor of this item, please email Chelsey McIntyre ( [email protected]).

Key Documents and Dates

• Medical devices – scientific advice pilot for high-risk medical devices, updated April 2, 2024