Brussels, 25 March 2025 – The Biomedical Alliance in Europe (BioMed Alliance), representing 35 leading medical and research societies, has published a comprehensive review detailing basic principles and practical solutions to address the persistent challenges in the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
The report highlights key issues that threaten patient care and medical innovation, including:
- Excessive certification costs creating financial burdens for manufacturers
- Insufficient clinical evidence and lack of transparency in regulatory processes
- Limited access to orphan and paediatric devices, jeopardizing patient care
- Increasing risk of devices being withdrawn from the EU market due to regulatory complexity
- Barriers to innovation that stifle research and development
- Increasing regulatory complexity adding uncertainty to the system
- Fragmented governance leading to inconsistencies in implementation across Member States
To address these challenges, the BioMed Alliance is calling for urgent action from EU policymakers and regulators, including:
- Enhancing regulatory efficiency by streamlining certification processes and increasing the capacity of notified bodies.
- Establishing a new coordinating division at the European Medicines Agency (EMA).
- Ensuring patient access to critical medical technologies by improving market availability.
- Strengthening support for innovation to foster the development of new medical devices.
- Increasing transparency and stakeholder engagement to create a more predictable regulatory environment.
Tom Melvin, Chair of the Regulatory Affairs Committee of the BioMed Alliance said: “The challenges to public health generated by the Medical Device and In-Vitro Diagnostic Device Regulations have triggered multistakeholder activism on how to rectify the defaults. This review incorporates the perspectives of practising clinicians and evidence from scientific investigations to recommend basic principles and practical solutions that can ensure that the MDR and IVDR meet the needs of the public, patients and healthcare practitioners.”
You can find the full document in the attachments below.
About the BioMed Alliance
The Biomedical Alliance in Europe (BioMed Alliance) is an alliance of 35 leading medical and research societies working together to advance biomedical innovation, improve patient care, and shape EU health policy. The Alliance plays a key role in shaping European health policies, collaborating closely with EU institutions, regulatory authorities, and stakeholders to address pressing challenges in the healthcare sector.
Contact information: Marieke Meijer | Policy and Communications Manager | marieke.meijer@biomedeurope.org