As negotiations on the revision proposal of the MDR and IVDR are at a critical moment, BioMed Alliance has updated its position statement with suggestions for changes and published a new briefing on the use of in-house diagnostic devices.
In December 2026, the European Commission presented its proposal on the revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) (2025/0404 (COD) which could entail a significant reform of the system. While the proposal takes important steps towards simplifying the regulatory framework, certain elements risk lowering safety standards, weakening requirements for clinical evidence and reducing transparency. The Parliament and the Council are currently discussing the proposal. The IMCO Committee has already published a draft opinion and the ENVI Committee is expected to follow soon with its proposed position on the text.
BioMed Alliance particularly welcomes the Commission’s proposed changes to article 5.5 of the IVDR, which focuses on the use of in house devices in the diagnostic sector. In house IVDs are widely used, and play a key role in e.g. rare diseases, addressing unmet medical needs, resilience against health threats and they fill a gap in the diagnostic test portfolio that would otherwise be unfilled. IVDR brought with it a heavy administrative burden for laboratories complicating the use of such devices, and the proposed changes including the removal of 5.5c which would play an important role in alleviating this burden. In addition, the amendment of 5.5a would facilitate sharing between healthcare institutions. More information on the use of in house devices is provided in a new briefing that BioMed Alliance prepared and that is available here.
On the medical devices side, some of the changes that the Commission proposed could facilitate the availability of devices on the market, while others might prioritise simplification over strong safety standards. The Alliance is particularly concerned about the provisions that would facilitate reliance on equivalence in the clinical evaluation of devices, and the unlimited validity of certificates for high-risk devices. Healthcare professionals also call on policy makers to improve transparency, add paediatric devices to the definition of orphan devices, and to facilitate the repurposing of medical devices.
The Alliance’s new position is an updated version from the document that was published in March 2026, and includes new proposals for changes. It aims to support meaningful simplification of the regulatory framework without compromising safety standards or the transparency of clinical evidence, both of which are essential to maintaining a high level of patient care and safety in Europe.
