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

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.

03 December 2024Read more

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!

07 November 2024Read more

BioMed Alliance welcomes the introduction of the Q&A of article 10a in the IVD and MD Regulation

We are pleased to welcome the European Commission decision to include the Q&A on Article 10a, "The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Medical Devices," within the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). This new mechanism aims to create a much-needed framework for managing shortages and ensuring continuity in the availability of critical medical devices across Europe. The Q&A provides guidance on the practical aspects on the obligation to inform about interruption or discontinuation of supply. As a results of our advocacy activities to protect patients’ access to life-saving devices and diagnostics, earlier this year, we issued a statement highlighting our deep concerns over issues with the availability of In Vitro Diagnostic Devices (IVDs) in Europe. The BioMed Alliance warned of widespread challenges due to delayed IVDR implementation, the limited number of certificates being issued, ongoing delays in the EUDAMED database, and general industry unpreparedness. These issues have raised the serious risk of losing essential IVDs from the market, which could compromise patient care and Europe’s competitive standing in the global medical device sector. To counter these challenges, our January statement called for a mix of short- and long-term reforms, including an urgent extension of the IVDR transition period and targeted updates to the system's framework. The new Q&A guidance of Article 10a provision now provides a structured response to manage supply interruptions, ensuring that information flows effectively between manufacturers, regulators, and healthcare providers. Article 10a not only reinforces patient access to essential devices but also strengthens Europe’s position in the global medical technology market. We remain committed to further actions that ensure the sustainability and efficacy of Europe’s medical device sector for the future.

04 November 2024Read more

Plans made in haste to change Medical Device Regulations (MDR) risk further neglecting the needs of patients who rely on medical technologies.

Following the recent plenary session of the European Parliament, the BioMed Alliance publishes a new statement sharing its concerns about the debate on accelerating the evaluation of the Medical Devices Regulation (MDR). The MEPs are calling on the European Commission to release a new proposal within 100 days of being in office. While the Alliance agrees that there are pressing issues that need to be addressed, there are serious concerns that rushing the evaluation process could undermine patient safety and the overall integrity of the MDR. The MDR was designed to ensure the safety and effectiveness of medical devices through stringent standards. The Alliance agrees that immediate short-term measures are necessary to address pressing issues, including the limited availability of orphan and paediatric devices, however hastily revising the regulation without careful consideration of the impact and consultation with stakeholders risks compromising its robustness. Moreover, these changes may fail to address the deeper structural issues behind the delays, such as problems related to high costs of certification, innovation leaving the market and governance issues. We urge decision-makers to allow more time for a comprehensive evaluation of the MDR, ensuring that any changes truly benefit patients without sacrificing the regulation's core goals. BioMed Alliance therefore calls on policy makers:

To support the detailed review of the regulations that the European Commission is currently undertaking
To avoid implementing short-term legislative measures without a careful diagnosis of the key shortcomings in the system
To address fundamental problems based on scientific principles
To ensure that revisions to the IVDR are considered separately, due to the different needs of the diagnostic sector
To implement targeted short-term measures to mitigate shortages of medical devices, and particularly of orphan devices and paediatric devices, separately from the more comprehensive review of the regulations

14 October 2024Read more

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.

16 January 2024Read more

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.

11 June 2022Read more

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.
1. 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.
2. 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

03 January 2022Read more

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