Medical Devices
Description
In this task force, high-level experts in this field discuss the latest developments in the regulatory framework for medical devices. They exchange key insights and interpretations of the EU medical devices framework and identify areas where the BioMed Alliance can provide input and expertise to enhance the safety of medical devices in Europe. They also explore opportunities for reaching out to key stakeholders and organisations in the medical devices field, both within Europe and beyond.
Chair
This task force is chaired by Prof. Alan Fraser and Prof. Per Kjærsgaard-Andersen.
Board Representative
The Board Representative for the Committee is Prof. Sanja Kolaček.
Highlights
Healthcare professionals share their views on the future of the regulatory system for medical devices and IVDs
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.
News
Biomed Alliance response to the Call for Evidence on Medical devices and In Vitro Diagnostics – targeted revision of EU rules
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.
News
New CORE-MD recommendations on strengthening clinical evidence for high-risk medical devices
On 15 September 2025, the CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium published new expert recommendations in The Lancet Regional Health Europe on how to improve clinical investigations of high-risk medical devices in the EU.
The report is a key outcome of the CORE-MD project, which the BioMed Alliance contributed to as a partner and which concluded in 2024. The recommendations aim to address significant gaps in the evaluation of high-risk technologies, including cardiovascular implants, orthopedic devices, and diabetes management systems.
Key recommendations include:
- A four-stage framework for clinical investigations, from initial studies through to long-term follow-up.
- Greater use of randomised controlled trials, including sham-controlled trials with appropriate ethical safeguards.
- Efficient large-scale trials embedded in registries to accelerate evidence generation.
- Mandatory transparency of study design, protocols, and results.
- Tailored approaches for breakthrough or orphan devices, requiring post-market confirmatory studies.
Event
Join Us for a Workshop on the Future Directions for EU Medical Devices & IVD Regulations!
Join us for an in-depth workshop focused on the key challenges surrounding the implementation of the Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), particularly in light of the ongoing evaluation process. This event will bring together key stakeholders from across the medical devices landscape to engage in meaningful discussions. We will explore critical issues such as limitations in clinical evaluation, challenges associated with the use of in-house IVDs, and the reduced availability of essential devices in Europe.
In addition to expert presentations, the workshop will feature interactive roundtable discussions where participants will collaborate to identify solutions on the way forward. The event will be followed with a networking cocktail!
Register here!
Statement
New statement advocates for a balanced approach to phasing out PFAS
In a new statement, BioMed Alliance provides insight on the harmful impacts of Per- and polyfluoroalkyl substances (PFAS) and urges manufacturers of medical devices to find safe alternatives whilst ensuring that essential devices don’t disappear from the market. The statement advocates for a balanced approach for the phasing out of PFAS by advocating for research on finding alternatives as well as facilitating the use of exemptions for a limited time period in order to avoid the loss of medical devices from the market.
Statement
New statement raises awareness on urgent deadline to avoid medical devices from disappearing
In a new statement, BioMed Alliance highlights its concerns regarding an imminent deadline in the Medical Devices Regulation (MDR), which will manufacturers have to meet to keep their devices on the market. It is foreseeable that devices may be withdrawn from the European market in the coming period, which could lead to shortages of medical devices.
As of 26 May 2024, manufacturers will be required to meet a critical deadline for legacy devices, in order to benefit from the extended transition periods. By this date, they will need to have applied for conformity assessment under the new regulation with a notified body, and have a MDR Quality Management System (QMS) in place. Due to several reasons including the high costs of certification, manufacturers may decide not to apply for MDR and their devices will thus not benefit from the extended transition period after the 26th of May. Particularly devices for small patient groups, such as paediatric and orphan devices may be affected. In response, the statement provides both short and long-term recommendations aimed at preventing the potential loss of medical devices.
Statement
Statement raising awareness on urgent deadline to avoid medical devices from disappearing
In a new statement, BioMed Alliance highlights its concerns regarding an imminent deadline in the Medical Devices Regulation (MDR), which will manufacturers have to meet to keep their devices on the market. It is foreseeable that devices may be withdrawn from the European market in the coming period, which could lead to shortages of medical devices.
As of 26 May 2024, manufacturers will be required to meet a critical deadline for legacy devices, in order to benefit from the extended transition periods. By this date, they will need to have applied for conformity assessment under the new regulation with a notified body, and have a MDR Quality Management System (QMS) in place. Due to several reasons including the high costs of certification, manufacturers may decide not to apply for MDR and their devices will thus not benefit from the extended transition period after the 26th of May. Particularly devices for small patient groups, such as paediatric and orphan devices may be affected. In response, the statement provides both short and long-term recommendations aimed at preventing the potential loss of medical devices.