BioMed Alliance is happy to share another special end-of-the-year Update looking back at some of the highlights of the past year and providing information on new policy developments at the end of the Update. Read our December Update here.

Continuing challenges for the implementation of the EU Medical Devices Regulation (MDR) will be discussed by health ministers during the EPSCO meeting on 9 December.

The BioMed Alliance believes that a variety of measures is necessary. It will support an extension of the recertification deadline of 26 May 2024, on condition that standards for clinical evidence are maintained. Added time should be used by policy makers to rectify issues that inhibit full implementation of the MDR, including the capacity of notified bodies and the need for a special framework to support the development and certification of orphan medical devices. Manufacturers should also use the extra time to send in applications of sufficient quality as soon as possible. At the same time, the Medical Device Expert Panels should play a greater role in the early dialogue with manufacturers, and registries should be used to support certification with conditions for market surveillance, as they already provide a wealth of information on the safety of devices and their impact on clinical outcomes. Policy makers should also consider setting up conditional approval procedures in exceptional circumstances to serve as a measure of last resort for devices that are at risk of disappearance and are used to treat life threatening conditions.

More info here.

Take a look at our October Update to stay up to date on our recent activities and important developments at EU level. In this update you will find more information on issues around the availability of medical devices, advocacy efforts related to the European Health Data Space, our response to the consultation on cross-border activities of associations, the EU Health Summit, upcoming IHI calls and other news. Don’t forget to subscribe if you want to receive our Updates directly in your inbox.

The Biomedical Alliance in Europe (BioMed Alliance) welcomes the efforts of the European Commission to ensure a full single market freedoms for associations, simplifying their cross-EU activities and promoting their fundamental rights. Our members are professional non-profit medical association based in various European countries and they organize many cross-border activities. The particularity of European medical societies is that they provide services to the health community across Europe such as: congresses, educational events, courses, guidelines, health research and clinical practice activities. The current rules in different countries create obstacles and many barriers additional registrations, different VAT rules, lack of harmonization of cross border employment, different legal provisions of annual revenue allowance for NPOs, lack of mutual recognition of services provided by associations and NPOs such as training certifications (congresses, courses, educational events) from one Member State to another.  

We encourage the European Commission to take this seriously as it affects a 90 billion EURO a year industry, but also the capacity of medical societies to deliver unbiased services for EU health community. In the table below you can find concrete input and recommendations provided by the BioMed Alliance members to consider when putting together a legislative framework aiming at creating a single market for associations.

Read the full feedback here.

Take a look at our September Update to stay up to date on our recent activities. In this update you will find more information on more information on our recent activities and important developments at EU level. Don’t forget to subscribe if you want to receive our updates directly in your inbox.

Healthcare stakeholders statement SM post

On 20 October, BioMed Alliance joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space (EHDS). The stakeholders, which include medical professional and research organisations (including several of our members), patient representatives, industry associations and data collaborations strongly support the aims of the EHDS as proposed by the European Commission. We believe the adoption of the new legislation “can bring important European alignment to, and rapidly scale up, well-governed access to health data sets for the delivery of healthcare services but also for a wide range of secondary use purposes for better health outcomes.”

The consensus statement encourages decision-makers to strongly support this Regulation and to engage with stakeholders to ensure the final Regulation optimises its potential. The statement also formulates several recommendations to consider when developing the more specific implementation plans to put this Regulation into practice across the Member States: It is in line with the previous BioMed Alliance Statement on the EHDS which is available here.

Main elements:

  1. A broad range of stakeholders must be strongly involved from the outset of the process to guarantee the success of the EHDS.
  2. The EHDS must align with all relevant horizontal and sectoral European laws.
  3. There must be harmonised interpretation and implementation of the Regulation across the EU.
  4. Approvals for secondary use of health data must be consistent and harmonised across Europe.
  5. The scope of EHR systems must be defined clearly within the Regulation.
  6. The successful implementation of the EHDS must be adequately resourced.
  7. Existing health data infrastructures must be leveraged to allow continuity and build on existing expertise.

Read the full statement of the stakeholder group here.

Take a look at our August Updateto stay up to date on our recent activities. In this update you will find more information on more information on our new survey on issues around the limited availability of medical devices, our upcoming General Assembly, the next EU Health Summit, a consultation of a proposed initiative on the cross-border activities of associations, members' news and upcoming meetings. Don’t forget to subscribe if you want to receive our updates directly in your inbox.

Medical Devices

BioMed Alliance has published an important new survey on the availability of medical devices, assessing if clinicians experience that any devices that they normally use are no longer available on the market. The survey was developed by BioMed Alliance in cooperation with ESC and is available here until 18 September.

Reports from clinicians, the European Commission and manufacturers have shown that there are issues around the availability of medical devices due to delayed certification procedures under the Medical Devices Regulation. This problem may become worse in the coming period if measures are not taken to address it, and many devices are at risk of being taken of the market with serious consequences for the provision of healthcare in Europe. For more information, see a recent BioMed Alliance press release on this topic.

This survey intends to assess whether clinicians in different fields are already experiencing issues around the availability of certain medical devices, which devices are affected and whether they expect to experience any issues in the future. The results will help us to gather more information on the extent of the issue and will serve as a basis for discussions with policy makers and stakeholders on this topic.

Fill out the survey here by 18 September 2022.

Read in our July update how BioMed Alliance kept being active during this sunny month. In this update you will find more information on the new BeWell project, our new consultation response on the European Health Data Space, the upcoming Research & Innovation Days and our CME Expert Committee activities.

EU Health Data Policy

The BioMed Alliance replied to the consultation on the proposal for the European Health Data Space (EHDS), welcoming the proposal but also highlighting a series of key considerations that should be taken into account in negotiations on the proposal and its implementation. The reply was developed following several meetings on EHDS and the collection of input from the taskforce. Among the issues that were raised were the need for synergies between EHDS for primary and secondary use of data, interoperability, the responsibilities of data holders, the need for regulatory clarity and the appropriate involvement of stakeholders. The response also includes a series of practical examples of the benefits and challenges related to health data sharing .

Read the BioMed Alliance consultation response here.

BeWell org picture

The BeWell consortium held its kick-off meeting on 14 July to discuss its upcoming activities around the project. BioMed Alliance is a partner in the project and works with 23 other organisations within the blueprint alliance for a future health workforce strategy on digital & green skills. Through different activities, the project will focus on how to upskill and reskill the European health workforce, particularly related to green and digital skills.

The project is funded by Erasmus+ and it started on 1 July and will run for 4 years. It contributes to the Pact for Skills initiative under the European Skills Agenda 2020 aiming to empower the healthcare workforce to participate in the twin transition. The Pact will facilitate collaboration between a wide range of public and private stakeholders by setting up a large-scale skills partnership embracing local, regional and national levels. 

Read the press release following the kick-off meeting here.

Our June update is out now and provides some great summer reading material on our activities and the latest news at EU level. In this edition you can find more information on our press release on concerns around the availability of medical devices, our selection for the HERA Civil Society Forum, our recent activities related to the European Health Data Space, an event on the HTA regulation, new IHI calls and members' news.

The BioMed Alliance published a new press release calling on Member States to take action and prevent a potential shortage of medical devices, ahead of the discussions during the EPSCO meeting on 14 June on the implementation of the Medical Devices Regulation.

Clinicians and researchers across all medical specialties strongly support the aim of the EU Medical Device Regulation to improve the standards of clinical evidence for high-risk medical devices, but are concerned that a large number of devices is at risk of being taken off the market due to unforeseen circumstances.

Read the press release here.

Read our May Update to get more information on our activities and the latest news at EU level. In this edition you can find more information on the proposal for the European Health Data Space and our related event, a recent article from our IVD task force, the CORE-MD survey (please note the deadline has now been extended to 30 June), a recap of our regulatory affairs committee meeting and BioMed Alliance participation in health policy events

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 is now online in HemaSphere here. The publication is very timely as it came just in time for the In Vitro Diagnostics Regulation (IVDR) Application date on 26 May 2022, which brings substantial differences in the approval and certification process of IVDs and additional requirements for diagnostic laboratories.

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.

Our April Update will provide you with an overview of a busy month for BioMed Alliance filled with activities and events. Read the Update to get more information on our recent Spring Meeting, our upcoming event on the European Health Data Space, an internal webinar on medical societies' efforts to support citizens & healthcare professionals affected by the conflict in Ukraine, a CORE-MD survey on education in regulatory affairs, our recent internal workshop on the EU Health Research Landscape, an upcoming IHI Stakeholder Event and members’ news.


The CORE-MD Project has launched a new survey, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory affairs. The survey takes around 10-15 minutes to complete and is open until 30 June. We need your help to promote it to ensure a large number of clinicians apply!

The CORE-MD survey will help to assess what sort of knowledge clinicians have on regulatory affairs (particularly related to medical devices), what sort of training they have followed, and what gaps in the knowledge exist. It will lead to the establishment of a roadmap which will inform policy makers and stakeholders on the needs for methodological expertise and educational requirements for the assessment of high-risk medical devices, specifically in the context of the EU Medical Device Regulation. This activity will be very helpful, as training in regulatory affairs can help clinicians to better contribute to the safety of the devices that they use to treat their patients.

The BioMed Alliance is a partner in CORE-MD, a European Union Horizon 2020 project that runs for 3 years from April 2021. It will review methodologies for the clinical evaluation of high-risk medical devices and recommend new designs to set an appropriate balance between innovation, safety, and clinical effectiveness. Within work package 4 which has developed this survey, we work to identify the training needs of all stakeholders to enhance their expertise in methodologies for the assessment of high-risk medical devices, and develop appropriate educational objectives.

It would be great if you could fill out the survey and share it with clinicians in your network so we can get as many replies as possible.

Fill out the survey here

banner EHDS

The European Health Data Space (EHDS) can have a very positive effect on health research, care and innovation but it is necessary that certain barriers are addressed to maximise related opportunities. The EU Health Coalition, with the support of BioMed Alliance, EAU, EFPIA and COCIR are organising a hybrid workshop with stakeholders and policy makers on 18 May to 'Maximise EHDS impact on better health data sharing'.

The European Commission proposal for the European Health Data Space (EHDS) is intended to facilitate health data sharing and access for healthcare delivery (primary use of data) and health research and policy making (secondary use of data). During the meeting we will discuss the EHDS proposal, how it will affect health data sharing, best practices in relation to health data sharing, benefits for research, and barriers to health data sharing that should be addressed in the EHDS implementation.

We hope that you will be able to join us on 18 May from 11.00-13.00, either in Brussels or online, to discuss the future of European Health Data Sharing!

Find the draft programme here

Register here

The developments around the Russian army's invasion of Ukraine are a clear violation of international law, and they have already had horrifying consequences and led to a serious humanitarian and health crisis. Support is essential, including through the provision of funds, medicines, medical equipment and expertise. Many European medical societies have put in place a variety of measures and activities to help local medical societies and healthcare professionals in Ukraine. In addition, these societies often had ties with Russian or Belarusian societies, and they had to decide whether to continue scientific exchange or to cut some or all ties. The BioMed Alliance has implemented a short survey to get a general picture of how BioMed Alliance members respond or plan to respond to the war in Ukraine, which was filled in by 27 organisations.

European Medical societies bring together healthcare professionals and researchers from all over Europe, and they often have Ukrainian medical societies or healthcare professionals among their members. All societies that replied to the survey issued a statement on the situation, almost half of all societies also indicated that they maintain close contact with local societies and provide support (48%). In addition, societies frequently donate to aid organisations (30%) or encourage members to donate (33%) and offer free membership (37%) or fellowships (11%) to Ukrainian clinicians. There are also societies that provide webinars and e-learning on treating war injuries (7%) or that provide equipment or medicines (7%) so healthcare professionals in the area can provide better care in challenging conditions. Many societies have also decided to exclude Russian or Belarusian colleagues from participating in their activities, and to refrain from organising meetings in Russia.

The BioMed Alliance is organising an internal webinar on 11 April, where we will hear from the European Commission how the EU is responding and what medical societies are doing and could do to help healthcare professionals and citizens in the area.

Statements & information from BioMed Alliance members mentioned in the survey:

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Take a look at our March Update to read about the latest news on our activities and new developments at EU level. This month you can get more information on medical society support for those affected by the conflict in Ukraine, the BioMed Alliance Spring Meeting and Workshop on Health Research Policy, a survey on support for research, our recent meeting of the CME experts committee, our activities on health data sharing and members news.