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
Article
Biomedical Alliance in Europe Calls for regulatory science-driven overhaul of EU Medical Device and Diagnostic Regulations
The Biomedical Alliance in Europe (Biomed Alliance) is calling on European policymakers to integrate regulatory science into the framework governing medical devices and in vitro diagnostics (IVDs). This follows the publication of a Viewpoint article in The Lancet Regional Health - Europe, which demonstrates how the European Union's current system remains hindered by a regulatory structure originally designed to harmonise standards for industrial products, rather than to safeguard health products.
Authored by leading clinicians and scientific experts on behalf of 35 medical professional associations, the publication emphasizes that the EU’s regulatory reliance on private "notified bodies"—which act as quasi-regulators in a competitive marketplace—has created a fragmented system lacking necessary transparency and scientific rigor.
This approach has resulted in unpredictable, protracted conformity assessments, driving manufacturers to withdraw essential products from the European market, including established technologies and vital medical devices for children and rare diseases. To ensure equitable access to safe, effective, and innovative technologies, the Biomed Alliance advocates for a renewed focus on integrating 'regulatory science' into European governing institutions.
Key priorities for regulatory reform are to:
- Centralise and resource scientific expertise: The EU must substantially invest in boosting medical and scientific capacity within a central coordinating unit. The mandate of the European Medicines Agency (EMA) should be expanded to assume a stronger coordinating function among national authorities for multi-national clinical investigations and post-market surveillance.
- Prevent the 'equivalence' loophole for high-risk technologies: High-risk implantable devices should not be approved solely on claims of equivalence to existing devices. This resulted in multiple cases of avoidable patient harm in the past, and these difficult lessons should not be unlearned. High-risk implantable devices require rigorous clinical investigations, to demonstrate both safety and efficacy.
- Protect diagnostic innovation and precision medicine: The current In Vitro Diagnostic Regulation (IVDR) heavily restricts laboratory-developed tests (In-House IVDs), which account for over 50% of available IVD tests and are critical for precision medicine and orphan indications. The EU must relax restrictions on sharing In-House IVDs between healthcare institutions and abolish IVDR Article 5.5 d, which currently stifles academic innovation in favour of manufacturers.
- Support the establishment of regulatory science as a medical subspecialty: Clinicians, statisticians, epidemiologists, and engineers must actively collaborate with regulators to develop shared standards, and 'regulatory science' must be cultivated as a dedicated subspecialty within every medical field.
Amendment document
Healthcare professionals share views as negotiations on MDR & IVDR Revision continue
As negotiations on the revision proposal of the MDR and IVDR are at a critical moment, BioMed Alliance has updated its position statement with suggestions for changes and published a new briefing on the use of in-house diagnostic devices.
In December 2026, the European Commission presented its proposal on the revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) (2025/0404 (COD) which could entail a significant reform of the system. While the proposal takes important steps towards simplifying the regulatory framework, certain elements risk lowering safety standards, weakening requirements for clinical evidence and reducing transparency. The Parliament and the Council are currently discussing the proposal. The IMCO Committee has already published a draft opinion and the ENVI Committee is expected to follow soon with its proposed position on the text.
BioMed Alliance particularly welcomes the Commission’s proposed changes to article 5.5 of the IVDR, which focuses on the use of in house devices in the diagnostic sector. In house IVDs are widely used, and play a key role in e.g. rare diseases, addressing unmet medical needs, resilience against health threats and they fill a gap in the diagnostic test portfolio that would otherwise be unfilled. IVDR brought with it a heavy administrative burden for laboratories complicating the use of such devices, and the proposed changes including the removal of 5.5c which would play an important role in alleviating this burden. In addition, the amendment of 5.5a would facilitate sharing between healthcare institutions. More information on the use of in house devices is provided in a new briefing that BioMed Alliance prepared and that is available here.
On the medical devices side, some of the changes that the Commission proposed could facilitate the availability of devices on the market, while others might prioritise simplification over strong safety standards. The Alliance is particularly concerned about the provisions that would facilitate reliance on equivalence in the clinical evaluation of devices, and the unlimited validity of certificates for high-risk devices. Healthcare professionals also call on policy makers to improve transparency, add paediatric devices to the definition of orphan devices, and to facilitate the repurposing of medical devices.
The Alliance’s new position is an updated version from the document that was published in March 2026, and includes new proposals for changes. It aims to support meaningful simplification of the regulatory framework without compromising safety standards or the transparency of clinical evidence, both of which are essential to maintaining a high level of patient care and safety in Europe.
Position statement
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.
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.