As negotiations on the revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) continue in the Council and European Parliament, BioMed Alliance and the European Patients’ Forum (EPF) have published a joint statement outlining their concerns about proposed changes to the rules on equivalence under Article 61 and Annex XIV of the MDR, which could weaken clinical evidence requirements for high-risk medical devices and put patient safety at risk.
The Commission’s proposal would facilitate the use of the equivalence pathway, including by removing the requirement for a contract ensuring full access to the equivalent device’s technical documentation. The Alliance and EPF are concerned that devices may enter the market based on insufficient evidence, and also refer to past examples of devices that were approved on the basis of equivalence and where serious safety incidents emerged.
BioMed Alliance and EPF therefore call on the EU institutions to:
- Revert to the original wording of Article 61(5) and Annex XIV paragraph 3 of the MDR, preserving the existing safeguards, including the requirement for a contract between manufacturers ensuring full access to the relevant technical documentation when equivalence is claimed for implantable or Class III devices
- Maintain strict criteria for demonstrating equivalence, requiring devices to have the same technical, biological and clinical characteristics, rather than allowing reliance on devices with merely similar characteristics
- Preserve robust pre-market clinical evidence requirements for high-risk devices, particularly Class III and Class IIb implantable devices given the potentially serious and long-lasting consequences of safety failures
Read the joint statement below to learn more about our concerns and recommendations.
