Dear Members, please see below update from MedTech Europe. This publication from Team NB outlines it’s position on Orphan IVDs under IVDR, which would also apply to Northern Ireland. It describes the suggested approach that the notified bodies would take when reviewing IVD that qualify as ‘orphan’ IVDs. There is a further meeting planned with the EC regarding the issue of orphan devices.
An orphan in-vitro diagnostic device, falling under the scope of the Regulation (EU) 2017/746, is intended to provide medical information to benefit patients in the treatment, diagnosis, or prevention of diseases or certain clinical conditions present in not more than 1 in 2000 people (prevalence) in the European Union
Dear members,
Please find the recent publication from TEAM-NB, dated 17 July, titled ‘Position Paper on Orphan In Vitro Diagnostic Medical Devices.’ here: Team-NB-PositionPaper-Ophan-IVDR-Medical-Devices-V1-20250717.pdf
Please note that there is alignment between the definition of orphan devices proposed by MedTech Europe and the definition put forward by TEAM-NB, as both emphasize same prevalence: An orphan in-vitro diagnostic device, falling under the scope of the Regulation (EU) 2017/746, is intended to provide medical information to benefit patients in the treatment, diagnosis, or prevention of diseases or certain clinical conditions present in not more than 1 in 2000 people (prevalence) in the European Union
Moreover, the position paper outlines several pragmatic approaches and recommendations for generating clinical evidence for orphan devices, including the possibility of addressing data gaps during the post-market phase. It also highlights important general considerations relevant to the development and assessment of these devices.
Also note that the technical documentation should be assessed following the same principles as for IVD medical devices that do not have an OD status. However, when assessing the manufacturer’s Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER), the product reviewers/clinical experts will consider the specific aspects addressed in this position paper, including the acceptability of limited pre-market clinical performance data and appropriate PMPF activities to generate additional post-market clinical performance data.
MedTech Europe is currently developing its own position paper and will use this opportunity to revise and refine our draft following a thorough analysis of the TEAM-NB publication.
Work at the European Commission level is ongoing, and the dedicated task force on orphan devices is scheduled to meet on 3 December.
