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.
