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. Michael Neumaier.
Board Representative
The Board Representative for this task force is Prof. Elizabeth Macintyre.
Highlights
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- Increasing risk of devices being withdrawn from the EU market due to regulatory complexity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.
News
New Policy Recommendations focus on Key Shortcomings in MDR & IVDR
The BioMed Alliance has released two policy documents which include recommendations of healthcare professionals to address persisting challenges in the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). While these regulations aim to enhance the safety and transparency of medical devices and diagnostics across Europe, there are certain shortcomings that must be addressed in the evaluation process that is currently ongoing.
Clinicians have raised key concerns, including delays in implementation, the limited capacity of Notified Bodies, high certification costs, delayed roll-out of EUDAMED and reduced patient access to essential devices—particularly for paediatric and orphan devices. Furthermore, increased requirements for diagnostic laboratories under IVDR threaten the availability of essential diagnostics.
To address these pressing issues, the BioMed Alliance calls for urgent action to establish a patient-centred regulatory framework that is transparent, consistent, evidence-based, risk-proportionate, flexible, efficient, and interactive.
BioMed Alliance’s policy recommendations emphasise the need for a new coordinating mechanism to tackle critical systemic challenges, such as:
- Excessive certification costs
- Insufficient clinical evidence and lack of transparency
- Limited access to orphan and paediatric devices
- Increasing risk of devices being withdrawn from the EU market
- Barriers to innovation
- Increasing regulatory complexity
- Fragmented governance
News
Your Expertise Needed: Apply to EMA SAGs and EU MD/IVD Panels
The European Medicines Agency (EMA) is calling for experts to join its Scientific Advisory Groups (SAGs) as part of the upcoming mandate renewal. These advisory groups, managed by the Committee for Medicinal Products for Human Use (CHMP), provide crucial scientific expertise in areas such as quality, clinical, non-clinical, and methodology domains. Experts contribute to scientific evaluations, marketing authorization applications, and the development of scientific guidance documents. Applications for the medicinal products call are open until December 15, 2024. More info available here.
BioMed Alliance also reminds you of the separate call for experts in the fields of In-Vitro Diagnostics (IVD) and Medical Devices (MD) for the European Commission. The demand for expertise in MD and IVD remains critical, as emphasized during our recent Training Day. The need for qualified professionals in these areas is urgent, and this call offers an excellent opportunity to contribute directly to the development of EU regulations, ensuring the safety and efficacy of health products across Europe. ghfghh fghhdfgfghjghjhsdd ghgdf gh sdfh hjhdf sdfh df frd
For more details on the call visit the link here.
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