Beginning February 27, 2023, companies with early-stage, high-risk medical devices will have the opportunity to start submitting letters of interest to participate in the European Medicines Agency (EMA) scientific advice pilot. This pilot will give an opportunity for ten companies of innovative devices to receive scientific input from experts on clinical trial plans intending to facilitate certification under the EU Medical Device Regulation (EU MDR). The scope of the pilot will include only medical devices and does not apply to In Vitro Diagnostics.
EU policymakers have recently approved compliance extensions, in the hopes of relieving pressure off many legacy devices that still need to transition to the EU MDR. Device groups have suggested that more “needs to be done to smooth the transition to the new regulation for the new devices, particularly innovative products developed by small companies.”1 With that said, the new EMA pilot will be conducted in two phases and will leverage the ten clinical specialty-focused expert panels, established as part of the EU MDR, to provide early advice to developers of innovative devices to also help avoid challenges later in the CE marking process. The ten clinical specialty expert panels are:
- Orthopedics, traumatology, rehabilitation, rheumatology
- Circulatory system
- Respiratory system, anesthesiology, intensive care
- Endocrinology and diabetes
- General and plastic surgery and dentistry
- Obstetrics and gynecology, including reproductive medicine
- Gastroenterology and hepatology
- Nephrology and urology
What the pilot looks like…
A firm that is interested will submit their clinical development plans and advice will be provided prior to the company initiating a clinical study. Feedback will not be provided by organizations that performs certification assessment, rather it will be provided by outside clinical specialty experts. The program will be voluntary and medical device developers will not be obliged to follow the advice provided, but EMA officials have stressed the importance of documenting any deviations from the recommended strategy so that the notified body can understand the full picture.
Although not mandatory to qualify for the pilot, the following is a criteria that will be considered by the EMA:
- Whether a product addresses a rare condition (orphan device)
- Whether a product addresses an unmet need
- Whether a product is a novel device with a “possible major clinical or health impact”
The pilot is based on a letter of interest that can be submitted starting February 27th, 2023, followed by a pre-submission meeting that will be set up with the relevant expert panel to assist the manufacturer in developing questions/answers for the full application. The panel will respond with recommendations by the 60-day mark, and converse with the respective company for clarifications before delivering the final report.
Source: European Medicines Agency, Miguel Antunes, Information Session, January 25, 2023
Important to note…
The pilot scientific advice will end around January or February of 2024. Upon the completion of the program, a survey will go out to the respective participated firms from the EMA to evaluate the process. The pilot will fully be funded by the EU, however, post-pilot will rely on company fees. There are still portions of the pilot that are under development. For example, there is discussion still about making public specific recommendations provided by expert panels to the company or rather to provide public summaries of recommendations to assist other manufacturers of similar devices.
CALL TO ACTION
If you are a manufacturer with a high-risk, innovative device and would like to have the opportunity to receive early feedback from the EU expert panels on clinical trial planning to help facilitate the EU MDR assessment process, be sure to submit your letter of interest beginning February 27th.
Kristina Poberezhnaya – Associate Medical Device Consultant