EPTRI POSITION NOTE: Revision of the Medical Device and In vitro Diagnostic Medical Device Regulations: Addressing the Specific Needs of Children and Young Patients
The European Paediatric Translational Research Infrastructure (EPTRI) has published a position note on the ongoing revision of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). The note argues that the current revision does not yet sufficiently recognise paediatric health and research as specific considerations within the medical device framework.
Children are not a homogeneous population. Differences in anatomy, physiology, developmental stage and disease presentation affect how devices are designed, evaluated and used. Paediatric populations are also often small and geographically dispersed, particularly, when we focus on orphan diseases. This makes evidence generation difficult and limits commercial incentives for manufacturers, delaying the availability of appropriate and innovative devices for children.
Where the legislation stands
The European Commission presented its proposal amending the MDR and IVDR on 16 December 2025. It is now being examined by the European Parliament, where the Committee on Public Health (SANT) is leading, and by the Council. The Parliament’s indicative date for the first-reading plenary vote is 14 December 2026.
EPTRI’s four recommendations
EPTRI proposes that Article 52a (MDR) and Article 48a (IVDR) be amended to:
-
Define paediatric devices. The definition would combine the age criterion (under 18) with an expected clinical benefit, so the pathway reaches devices facing real paediatric-specific challenges. EPTRI also argues that paediatric and orphan devices should remain distinct categories.
-
Provide dedicated expert advice. Manufacturers would have access to expert-panel advice on clinical development and evidence generation. EPTRI therefore proposes extending the expert-panel assessment and clinical development advice to confirmed paediatric devices.
-
Enable prioritised conformity assessment, including rolling review where appropriate, to reduce delays in bringing paediatric technologies to patients.
-
Support development and certification. This includes certification based on limited clinical data where the benefit-risk ratio is favourable and post-market follow-up is in place, paediatric development plans for devices marketed for adults, and fee reductions under Article 50(2).
EPTRI stresses that the aim is not to lower the level of evidence required. The aim is to make evidence-generation strategies scientifically appropriate and proportionate, while upholding safety, performance and clinical benefit.
Read the full position note HERE.
About EPTRI
EPTRI is a pan-European research infrastructure that connects specialised units across Europe and globally. It brings together expertise in paediatric research, clinical development, regulatory science and stakeholder engagement to accelerate innovative health solutions for children. EPTRI coordinates the EU4Health-funded project OrphaDev4Kids (2024–2027), which addresses barriers to developing medical devices and IVDs for paediatric and rare disease populations.