EU expert group established for pediatric and rare disease devices

The European Commission on Monday published a regulation that establishes a new expert panel on medical devices focused on pediatrics and rare diseases. The measure was supported by many organizations and patient groups in the EU, who expressed hope that the panels would encourage the development of more devices to treat the pediatric population.

The panel will provide scientific, technical, and clinical opinions to support the development of medical devices intended for small size patient populations, such as patients with a rare disease.

The decision was published in the Official Journal on Monday. The text of the decision remains essentially the same as the proposal to establish this expert panel. The only change is the addition of an Annex 1 which sets the maximum number of working days as well as the number of days individuals on the expert panels may be reimbursed for providing advice.

The European Medicines Agency (EMA) currently has 11 expert panels that offer scientific and technical expertise for evaluating medical devices under the Medical Device Regulations and the In Vitro Diagnostic Medical Device Regulations. This new expert panel will become the twelfth.

According to EMA, expert panels are tasked with several responsibilities: they provide their insights on the performance evaluation of high-risk in vitro diagnostic medical devices, advise the Medical Device Coordination Group (MDCG) and the European Commission on the safety and effectiveness of medical devices and in vitro diagnostic medical devices, and encourage Member States, manufacturers, and notified bodies to consider various scientific and technical matters.

The deadline for submitting comments on the proposal was June 16. The Commission received a total of 96 comments, many of which expressed support for the proposal. Several commenters expressed hope that the expert panels would assist in promoting the development of pediatric orphan devices, which they feel is currently lagging.

MedTech Europe said it “welcomes the expansion of the expert panels' scope to include a dedicated panel for paediatrics and rare diseases…. Overall this is a very welcome initiative, especially in light of the serious challenges posed by MDR and IVDR implementation, which have already contributed to the discontinuation of life-saving devices across multiple areas of healthcare, particularly in low-volume or high-need contexts such as paediatrics and rare diseases.”

EURORDIS, which is a nonprofit group comprising over 1,000 rare disease patient organizations, also expressed its support for the proposal. “The proposal to establish an expert panel dedicated to orphan and paediatric medical devices is strongly supported. Currently, there are very few devices specifically developed for rare diseases and children, yet these devices are essential for patients, carers, and healthcare professionals managing complex and rare conditions.”

Commission regulation

EU expert group established for pediatric and rare disease devices

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