The BioMed Alliance in Europe represents medical societies at the European level. It is active to voice the concerns and expectations of medical specialists and raise awareness on the need to involve healthcare professionals in ongoing health-related issues.
EFORT is an active member of the Biomed Alliance and has been contributing to several initiatives on medical devices. Recently, it relaunched its survey on medical devices to gain insight on concrete issues faced by Orthopaedic and Traumotology Surgeons. It also took part in the Commission’s workshop (Brussels, 20 March 2025) organized to receive input from the civil society on the implementation of the Medical device Directive.
On 25 March 2025, Biomed Alliance has published a comprehensive review outlining key challenges and proposed solutions for 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- Increasing risk of devices being withdrawn from the EU market due to regulatory complexity.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, we are 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.
More information
- BioMed Recommendations MDR & IVDR 2025 | PDF Document | 52 pages | 1Mb
