Among the measures announced by the EU Commission for the health sector at the end of 2025 is the simplification of the Medical Devices (MDR) and In Vitro Diagnostics (IVDR) regulations. The updated provisions aim to enhance the legal certainty, predictability and cost-efficiency of certification by reducing timelines, adjusting classification rules and utilising real-world data to collect clinical evidences. These planned simplifications will particularly benefit SMEs, which represent 90% of medical device manufacturers in the EU.
Electronic instructions for use shall be available to healthcare professionals. The revision will also include more proportionate and targeted conformity assessment requirements, particularly for low- and medium-risk class devices and orphan devices. Procedures concerning AI-based medical devices will also be streamlined to avoid duplication and facilitate single procedures. The European Medicines Agency and expert panels will play a more active role in providing EU-level scientific expertise. The Commission has also addressed the need for better coordination and oversight of the notified bodies system at EU level, and the introduction of streamlined, digital procedures.
Reactions of the industrial associations
According to MedTech Europe, the ultimate objective of the MDR and IVDR targeted revision should focus on the identification of areas of underperformance, while maintaining current effective processes. The association welcomed the proposed introduction of pathways for breakthrough innovation and orphan devices, as well as regulatory sandboxes. However, the absence of a single governance structure is considered a missed opportunity for long-term system stability. MedTech Europe also highlighted a persisting gap on clinical evidence expectations. Regarding the in vitro diagnostics sector, the proposed new rules should be included in the same proposal as those for medical devices, meaning co-legislators should not lose focus on the amendments to the IVDR.
AESGP, representing the European self-care industry, particularly welcomed the removal of the re-certification requirement and the extension of reporting timelines for periodic safety update reports. Other positive actions include reducing the scope of the requirements to provide a summary of safety and (clinical) performance (SS(C)P), and a reduced involvement of notified bodies in conformity assessments of lower- and medium-risk classes. Positive opinions have also been expressed regarding the proposed legal basis for structured dialogue between notified bodies and manufacturers, the possibility of expanding the use of non-clinical data, and the planned actions for digital labelling and the digitalisation of documentation for conformity assessment.
EFPIA and Vaccines Europe have welcomed the the coordinated assessment of combined studies, as well as EMA’s support for competent authorities in the context of multi-country clinical studies. Other positive actions include the new criteria for breakthrough and orphan devices, the establishment of a dispute resolution mechanism, greater flexibility for in-house devices, and an enhanced role for expert panels. However, according to the two associations, the revision failed to meet its long-term goal of centralising processes.
