New guidance on the clinical evaluation of orphan medical devicespublished

The European Commission has published guidance on the clinical evaluation of orphan medical devices.

Orphan devices are medical devices or their accessories, which are intended to be used for diseases or conditions affecting only a small number of individuals each year. Often, they are used to treat a rare disease or medical condition for which very few diagnostic or therapeutic options exist. Orphan devices can be crucial to fulfil an otherwise unmet medical need.

Today’s guidance provides criteria for determining when a medical device or an accessory for a medical device should be regarded as ‘orphan device’ under the Medical Devices Regulation 2017/745 (MDR). It aims to guide manufacturers and notified bodies when applying the MDR’s clinical evidence requirements and help overcome some of the challenges that lead to delays in patient access to orphan devices. The guidance includes the possibility for manufacturers and notified bodies to seek advice from European Medicines Agency expert panels on the orphan device status and the clinical data needed for their clinical evaluation.

This guidance was developed by the Medical Devices Coordination Group (MDCG), which is made up of representatives of the Member States and chaired by the Commission. It was done in collaboration with stakeholder representatives including healthcare professionals, academic societies, notified bodies and industry.

The guidance on orphan devices is one of the important actions endorsed by MDCG in August 2022 to enhance notified body capacity and to support manufacturers in the transition to the Medical Devices Regulations, see Daily News 29 / 08 / 2022 (

Guidance MDCG 2024-10