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Establishment of an expert panel on orphan and paediatric devices

Public health

With this implementing act, the Commission intends to set up an additional expert panel in the field of orphan and paediatric devices and update administrative aspects related to the management of the panels. Expert panels provide scientific technical and clinical opinions and advice in support of the implementation of the EU medical devices regulations.

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Public consultation

ID: 14473

Lobbying Activity

9 responses

Consultation response

MedTech Europe, 13 Jun 2025

MedTech Europe welcomes the expansion of the expert panels' scope to include a dedicated panel for paediatrics and rare diseases. We understand that the panels remit is to cover both medical devices and in vitro diagnostic devices (IVDs), and we suggest this be clearly stated in the implementing…

Consultation response

CropLife Europe, 16 Jun 2025

Dear colleagues, dear friends, Thank you for this very important information. I fully agree with the initiative to start the problem of procuring consumables for hemodialysis and peritoneal dialysis. As a pediatric nephrologist who has been doing HD and PD for years, I constantly for many years…

Consultation response

EUROPEAN ORGANISATION FOR RARE DISEASES, 16 Jun 2025

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…

Consultation response

European Social Insurance Platform AISBL, 16 Jun 2025

The European Social Insurance Platform (ESIP), representing social security institutions and healthcare payers across the EU, agrees with the European Commissions proposal to establish an expert panel for small patient populations, such as those with rare diseases or children. ESIP also welcomes…

Consultation response

European Kidney Health Alliance, 16 Jun 2025

Overcoming the shortage of specific dialysis material for children in Europe The European Kidney Health Alliance (EKHA) represents the European kidney community, including two leading pediatric kidney societies: the European Society for Paediatric Nephrology (ESPN) and the European Rare Kidney…

Consultation response

Confindustria Dispositivi Medici, 16 Jun 2025

Confindustria Dispositivi Medici (CDM), the Italian trade association for the MD and IVD industry, warmly welcomes this initiative and acknowledges the effort put in place by the European Commission in further enhancing the activities of the expert panels, with the inclusion of a dedicated expert…

Consultation response

Breakthrough T1D, 16 Jun 2025

Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments on the consultation for the draft implementing act on Medical devices establishment of an expert panel on orphan and paediatric devices. Breakthrough T1D supports the creation of an expert panel, which can provide…

Consultation response

European Renal Association, 12 Jun 2025

As Chairs of the EUDIAL working group of the European Renal Association focused on dialysis in Europe, we are deeply concerned about the impact of the EU Medical Device Regulation (EU MDR 745/2017) on the current and future availability of suitable medical devices required to provide dialysis…

Consultation response

Empowered By Us, 20 May 2025

Empowered By Us welcomes the European Commissions proposal to establish an expert panel on medical devices for orphan and paediatric populations. This is a timely and necessary initiative that recognises the distinct clinical and social challenges faced by those living with rare conditions or…