News - 2024
Plans made in haste to change Medical Device Regulations (MDR) risk further neglecting the needs of patients who rely on medical technologies.
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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
The statement is now available here
Update September 2024
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Read our new September Update and get an overview of recent BioMed Alliance activities and policy updates.In this edition you will find more information about our ongoing activities & events, the new nominated Commissioners on Health and Research, the call for applications to join the HTA Stakeholder Network, the call for expression of interest for medical devices and patient, consumer and healthcare professional experts, the new public consultation on medicinal products under the HTA Regulation, and information on upcoming events.
EMA seeks experts in medical devices and in patient, consumer and healthcare professionals.
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The European Medicines Agency (EMA) has launched a call for expression of interest for experts in medical devices and in-vitro diagnostics (IVDs) as part of the EXPAMED initiative. The purpose is to gather a diverse pool of experts who can provide scientific and clinical advice on the implementation of EU regulations for medical devices (Regulation (EU) 2017/745) and in-vitro diagnostics (Regulation (EU) 2017/746). The selected experts will contribute to the evaluation process of medical devices regarding patient safety, performance standards, and compliance with regulatory frameworks.
Additionally, the EMA has launched a call for expression of interest for Patient, Consumer and Health Care Professionals Experts (P&HCP). This particular call is targeted towards experts who can provide input on living with medical conditions and the therapeutic environment related to them, as well as healthcare professionals who have experience in clinical research and/or practice such as general practitioners, nurses, pharmacists, dentists, and so on. The tasks of the experts include contributing to the assessment of medicines, providing input on various documents including consultations and guidance documents and participating in stakeholder meetings as well as in EMA working groups and parties.
For more information on how to apply see the website here.
Join the first BioMed Alliance training day on regulatory affairs
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Have you always wanted to get more in-depth knowledge on how EU health policy making works and how you can have an impact? Then you should join the first BioMed Alliance training day on 27 November, where we will dive into these topics with a range of guest speakers from within BioMed Alliance and the EU policy sphere. The training session is dedicated to volunteers who would like to be more active in the EU health arena. The day will provide valuable information for healthcare professionals and researchers and focuses on policies like the regulatory framework for devices and diagnostics, digital health and health data, pharmaceutical legislation and HTA.
The event will also provide an excellent opportunity to connect and network with colleagues in person!
The draft programme is now available here and registration is available here.
Join the BioMed Alliance Workshop on how the healthcare & research community can help build the European Health Data Space
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BioMed Alliance is organising a public workshop on 'Building Bridges: how the healthcare & research community can help build the European Health Data Space' taking place on 15 October from 14:00-16:30 CET at the BioMed Office in Brussels. The workshop will be followed by a networking cocktail.
As we move to the implementation phase of the European Health Data Space (EHDS), there are still many challenges to be addressed to ensure EHDS has a concrete positive impact on the primary and secondary use of health data. During the workshop we will exploring ways in which the health stakeholder community can contribute, with policy makers, clinicians and researchers and other stakeholders from the health field. The event will also be a great opportunity to meet face to face and network with colleagues!
See the agenda here and register here
Update August 2024
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Read our new August Update and get an overview of recent BioMed Alliance activities and policy updates. In this edition you will find more information about our new member, a call for candidates for our Board, our upcoming training day, a questionnaire on the harmonization of specialty education, our recent discussions with EMA on involving experts, a new survey on monitoring the availability of medical devices, a survey on electronic instructions for use of medical devices, a new pilot program to support orphan medical devices, members news, and information on upcoming events.
Introducing ESTRO - The newest BioMed Alliance member
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BioMed Alliance is pleased to announce that the European Society for Radiotherapy and Oncology (ESTRO) has become its newest member.
Founded in 1980, ESTRO is a non-profit scientific organization that advances the role of radiation oncology in cancer treatment. With a membership base comprising of over 9,000 radiation oncology professionals from around the world, ESTRO is dedicated to promoting research, education, and clinical practice in the field of radiotherapy and oncology. The society's mission is to advance radiotherapy in various ways including, through education and practice standards, in research, in exchange of knowledge, and through collaborations in Europe and beyond, as well as with other professions in cancer treatment.
We look forward to working together with ESTRO as the Alliance continues to grow with new members.
Update July 2024
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Our July Update is out now and provides you with insights on EU policy developments and BioMed Alliance activities. In this edition you will find more information about our Call for Candidates for the Board of Directors, Updates from the EU Elections, the new leadership of the ENVI and ITRE Committees, the ongoing joint response on EACCME Criteria, the response to a new consultation on HTA & cooperation with the EMA, the BeWell Public Consultation, and information on upcoming events.
BioMed Alliance is looking for an intern
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The BioMed Alliance is looking for an intern that will join our small team in Brussels to work as a Policy and Project Officer. The intern will get the chance to promote the interests of 35 European Medical and Research societies and contribute to EU health and research policy. The 6-month internship starting in September also provides the opportunity to strengthen communication and policy related skills, and to take the first steps in your career in Brussels.
Read the job description here and apply by 19 August.
BioMed Alliance replies to new consultation on HTA & cooperation with the EMA
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In a new public consultation response, BioMed Alliance shares its views on the proposed implementing regulation detailing procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment (HTA) and the Commission with the European Medicines Agency. While welcoming the draft regulation, the Alliance also shares key recommendations on the timely and efficient exchange of information, creating synergies, involving experts, and balanced conflict of interest policies. The feedback is published on the EU Have Your Say Portal here, and replies to the consultation will be considered before the final regulation is adopted.
Read the consultation reply here.
Update June 2024
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Our June update is out now and provides you with insights on EU policy developments and BioMed Alliance activities. In this edition you will find more information about our recent reply to a HTA consultation on conflict of interest, a EU4Health Stakeholders' Conference, prioritising health post EU-Elections, the report on the Joint HMA/EMA multistakeholder workshop on Patient Registries, the EMJ Roundtable discussion with BioMed Alliance, the new Guidance document on the Clinical Evaluation of Orphan Medical Devices, the IHI Call 8, the study on Deployment of AI in healthcare, and information on upcoming events.
Medical societies share their views on managing competing interests in HTA
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The BioMed Alliance has replied to a public consultation on HTA on procedural rules for assessing and managing conflicts of interest. In the reply prepared by the HTA Working Group, the Alliance welcomed increased cooperation on joint Health Technology Assessment (HTA) as we believe this can enhance the affordable and equitable access to innovative new health technologies for European patients. Such assessments must be evidence-based, and depend on the feedback of patients, clinicians and other experts in the health field.
Transparency throughout this process is key. Declarations of interest must be shared, and risks of potential competing interests managed to reduce the risk of bias. However, conflict of interest policies must also be proportionate and take into account that many (leading) scientists and clinicians with the necessary expertise to provide an authoritative review of a new medicine or medical device, are likely to be involved in a variety of research, academic and regulatory roles. Too restrictive approaches may therefore prevent the inclusion of the necessary expertise, particularly in niche fields like rare diseases.
Read the reply here.
Update May 2024
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Our May update is out now and provides you with insights on EU policy developments and BioMed Alliance activities. In this edition you will find more information about the new statement on proposed PFAS restrictions, updates on the MDR, the Spring Meeting and the newly adopted SoHO regulation
Enhancing BioMed Alliance Activities with the EXHALE operating grant
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The BioMed Alliance has been awarded the EXHALE operating grant (BioMed Alliance EXpertise in Health Across Legislation at EU level) for 2024 under the EU4Health programme (grant agreement no 101176496). This grant aims to further strengthen the representation of medical societies, healthcare professionals, and researchers in the EU health field.
The EXHALE grant will enable the Alliance to enhance the expertise and knowledge of the medical and research communities on the regulatory system and policy developments in the health field, and how these impact their work. The focus will be on EU4Health priorities including the Medical Devices Regulation, In Vitro Diagnostics Regulation, the European Health Data Space, Health Technology Files, and the Health Emergency Preparedness and Response authority.
Over the coming months the BioMed Alliance will work with its Committees and Task Forces to build on the proposed activities, strengthen its representation at EU level and build skills in the regulatory field. We will organise a series of workshops and share materials, and more information will follow soon.
New statement advocates for a balanced approach to phasing out PFAS
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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.
Read the full statement here.
Update April 2024
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Our April Update is out now and provides you with insights on EU policy developments and BioMed Alliance activities. In this edition you will find more information about the new statement on the implementation of the EHDS, the consultation survey on the EU4Health programme, the new statement on the MDR, theEU4Health operating grant received by BioMed Alliance, the ESCMID Global congress, and member news.
New statement raises awareness on urgent deadline to avoid medical devices from disappearing
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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.
Read the full statement here.
Implementing EHDS: medical societies advise on how to bring health data sharing to the next level
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In a new BioMed Alliance statement, medical societies provide key recommendations on the European Health Data Space (EHDS) implementation. The statement follows the European Parliaments adoption of the political agreement with the Council on 24 April and highlights what is necessary to make EHDS provide a concrete added benefit to patients, doctors and researchers across Europe.
In the statement, the 34 members of the Alliance welcome the agreement, while providing input on remaining key issues that need to be addressed in the implementation and operation phases. These include the need for further stakeholder engagement, the importance of ensuring a harmonized opt-out mechanism, further clarification for definitions and legality, and increased support for healthcare professionals and researchers. We invite you to read the full statement here.
Charting the path forward: New joint stakeholder statement on the implementation of the EHDS
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BioMed Alliance contributed to a new statement on the implementation of the European Health Data Space signed by 36 organisations representing healthcare professionals, patients, industry and other health-related stakeholders. In the statement, the EU health community welcomes the agreement on the European Health Data Space (EHDS) proposal, but also provides key recommendations to ensure the EHDS will be implemented in a way that provides most added value for patients and European health systems. Read the statement here.
Update March 2024
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Our March Update is out now and provides you with insights on EU policy developments and BioMed Alliance activities. In this edition you will find more information about the passing of our former BoD member Tobias Welte, progress with the AI Act, EHDS and revision of the pharmaceutical legislation, the final conference of CORE-MD, the agenda of our Spring Meeting, a HERA survey on training needs, the launch of the Critical Medicines Alliance and member news.