Supporting Innovation
The EU wants to promote innovation. The term ‘breakthrough’ medical devices is already being used in the MDR. Having been overlooked for years, the term has been receiving renewed attention since December 2025: the Medical Device Coordination Group MDCG published guidance setting out the applicability of the ‘breakthrough’
Insert: MDCG guidelines are not legal texts, but interpretations of legal texts. The interpretation that is ultimately binding must always be formulated by a competent court. The MDCG exists, in particular, for the purpose of harmonising the interpretation of the Brussels Regulations and can therefore be regarded as a reliable point of reference.
Definition of the MDCG
In its draft, the MDCG stipulated that ‘breakthrough’ products are defined as any products that
- Possess novelty – that is to say, are novel in terms of the device-specific technology and the clinical mode of action of the product or the method of use of the product,
AND - Demonstrate a high or specific clinical benefit – that is, where the product achieves a higher level of clinical benefit than comparable products are capable of, or achieves a clinical benefit that is not adequately met by any available product – in particular where the clinical benefit is high, that is, where it reduces life-threatening, irreversible or public health risks.
EMA: A New, Old Player
Then, at the end of April 2026, news came from an unexpected quarter: the European Medicines Agency (EMA), which is not generally known for taking much regulatory initiative with regard to medical devices, launched a Pilot Programme to support the development of ‘breakthrough’ medical devices – based on the MDCG’s definition from December 2025.
In this pilot project, the EMA refers to Article 52a – an article which does not yet feature in the current MDR, but which is included in the European Commission’s Proposal for a Revision, also dated December 2025.
It would therefore appear that the EMA is already firmly assuming that the Commission’s proposal will be implemented in the not-too-distant future.
The EMA will initially take on an advisory role for breakthrough products. It aims to support manufacturers of potential breakthrough products, drawing in particular on its scientific and regulatory expertise.
Conclusion
The category of breakthrough products is now becoming a regulatory reality.
Although the term has been in use within the MDR since 2017 – albeit with little significance – since December 2025 it has evolved into a narrowly defined and robust designation, the holders of which are granted special status within the MDR – initially, and above all, the special attention of the EMA.
The case of ‘Breakthrough’ devices illustrates clearly how new categories are being established in the field of regulatory affairs. It now remains to be seen in which cases the EMA will recommend ‘Breakthrough’ designation and what specific provisions will be included in the version of the MDR that may soon be superseded.
One thing is certain: BEO BERLIN will support you through all these changes. With its usual calm and composure, always in a spirit of partnership, always professionally.
Please do not hesitate to contact us.
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