In Vitro Diagnostics
Description
The Task Force on In Vitro diagnostics was established based on decisions in the BioMed Alliance Taskforce on Regulatory Affairs and Medical Devices. A new EU regulation on In Vitro Diagnostics will come into effect in 2022 and will have a major impact on the evaluation and approval process of IVDs. In preparation for this, and to facilitate member society cooperation on the regulatory aspects of in vitro diagnostics, this task force composed of IVD experts was established in 2019.
Chair
This task force is chaired by Prof. Elisabeth Dequeker.
Board Representative
The Board Representative for this task force is Prof. Elizabeth Macintyre.
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
BioMed Alliance publishes new comprehensive review of regulatory framework for medical devices and IVDs
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
- 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.
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
Urgent action needed to prevent widespread shortage of diagnostic tests
In a statement from January 2024, BioMed Alliance highlights its increasing concerns about approaching widespread issues with the availability of In Vitro Diagnostic Devices (IVDs) in Europe.
Persisting problems with the implementation of the In Vitro Diagnostics Regulation (IVDR), insufficient certificates issued, the failure to deliver the EUDAMED database and general unpreparedness of the sector could lead to the disappearance from the market of a large number of essential IVDs in the near future and related loss of international competitivity compared to other jurisdictions.
The document calls for a mix of short-term solutions (including an extension of the transition period) and more longer-term reforms of the system to ensure pressing challenges are addressed.
Article
BioMed Alliance article on the implications of IVDR for innovation in diagnostics in HemaSphere
The BioMed Alliance In Vitro Diagnostics (IVD) Task Force has written an article on the Critical Implications of the In Vitro Diagnostics Regulation (IVDR) for Innovation in Diagnostics, which was published in June 2022 in HemaSphere and is available here.
The article addresses different elements around the IVDR implementation and its consequences for innovation and the work of laboratories, including for the development and use of in-house devices. It builds on the conclusions from our recent survey addressing laboratory preparedness for the IVDR and provides recommendations on important challenges to be addressed and for the way forward.
EU Resources
Useful documents for the IVDR requirements
In-house IVDs (IH-IVDs or often called LDTs) are exempt from most provisions of Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, IVDR) provided they meet the conditions set out in Article 5(5) of the IVDR.
The Association of the Scientific Medical Societies in Germany (AWMF) ad hoc commission provides documents as recommendations and assistance for the following IVDR requirements:
- 5 (5 f): Public statement confirming compliance with general safety and performance requirements
- 5 (5): Determination and documentation of compliance with the general safety and performance requirements listed in Appendix I.
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- Detailed checklist in which each individual point of Annex I of the IVDR is addressed and evaluated. The 2nd tab is particularly helpful for laboratories that are accredited according to ISO15189.
- Compact checklist that queries the requirements of the IVDR for the commissioning of IH-IVD in the categories reagent, reagent product, calibrator, control material, kit.
- Appendix I chap. I: IVDR compliant risk management
- Appendix I, chap. II (9): IVDR compliant performance evaluation
- Handouts for validation of virological / microbiological examination methods