In Vitro Diagnostics

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.

With the recent publication of the European Commission's proposal to revise the Medical Devices Regulation and In Vitro Diagnostics, the EU has the opportunity to modernise the regulatory framework. But how do we find the right balance, and ensure that legislation enhances access to devices and diagnostics while ensuring sufficient safety standards are in place? Healthcare professionals within the BioMed Alliance have come with a new set of recommendations that would help ensure that the revision proposal is future proof, supports innovation, enhances predictability and transparency all while increasing safety and trust. While medical societies continue to support the MDR and IVDR's objectives, the unintended consequences of their implementation have led to high costs, excessive administrative requirements and reduced access to essential devices and diagnostics, thereby negatively impacting patient care across Europe. Summary of our position:

• Simplification of regulations should not imperil the safety of medical devices.
• Proposed changes to MDR and IVDR article 5.5 on in-house devices, should reduce the administrative burden for health institutions, while facilitating innovation and the safe sharing of devices and diagnostics between health institutions, thereby improving patient access to state-of-the-art personalised care.
• The amendment to the AI Act must not lead to reduced requirements for AI-medical devices, and Chapter III requirements in the act must be upheld.
• Transparency of clinical evidence for patients and healthcare professionals must be improved including by making information on clinical evidence and SS(C)Ps available, in an easily accessible and readable format.
• The expanded role for the Expert Panels for Medical Devices and IVDs and the European Medicines Agency has the potential to improve scientific coordination and support in the system.
• Pathways for Orphan & Breakthrough devices and diagnostics may facilitate their approval and ensure better availability in the EU, thereby enhancing patient access.
• The expanded use of equivalence for the approval of high-risk medical devices under MDR will lead to more safety concerns, this provision must either be removed from the proposal or the pathway must be subject to specific controls.
• The safe reprocessing and repurposing of devices can facilitate healthcare and reduce waste, but any reprocessing must adhere to strong safety standards.
• With the removal of the 5-year validity of certificates under MDR, it is essential to better monitor the safety of implantable high-risk devices long term, since safety issues may occur after several years.
• Implant cards for Well Established Technologies must also be retained as a vital tool for patients in MDR.

On 6 October 2025, the BioMed Alliance submitted its response to the European Commission’s call for evidence regarding the targeted revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). While the Alliance welcomes the Commission’s goals to safeguard patient safety and support innovation, it also highlights challenges that must be addressed to ensure continued patient access to safe, effective, and innovative technologies. The Alliance highlights several recommendations, including the neeed to ensure stronger central coordination at the EU level.