Description

In this task force, high-level experts in this field discuss the latest developments in the regulatory framework for medical devices. They exchange key insights and interpretations of the EU medical devices framework and identify areas where the BioMed Alliance can provide input and expertise to enhance the safety of medical devices in Europe. They also explore opportunities for reaching out to key stakeholders and organisations in the medical devices field, both within Europe and beyond.

Chair

This task force is chaired by Professor Alan Fraser.

Highlights

  • BioMed Alliance survey on the limited availability of certain medical devices

    BioMed Alliance published an important survey on the availability of medical devices in August 2022. It assesses 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 many devices are at risk of being taken of the market in the coming years with serious consequences for the provision of healthcare in Europe.


    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.

  • Press release calling for urgent measures to ensure the continuing availability of essential medical devices

    The BioMed Alliance published a 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.
  • BioMed Alliance promotes European Commission call for Medical Devices experts

    The BioMed Alliance helped the European Commission to promote a call for additional candidates to be part of the Medical Devices Expert Panels (EXPAMED). The panels play a key role in evaluating high-risk devices and thus help to ensure the safety of medical devices and in vitro diagnostics in the EU.

    The first call for experts was published in 2019, and since then the panels have started their work under the new Medical Devices Regulation and the In Vitro Diagnostics Regulation. Due to different circumstances and a large number of devices to evaluate, additional applications are welcomed in several fields. BioMed Alliance and its members have promoted both the initial call in 2019, a request for experts in 2021 and the third request for additional applications in 2022.
  • CORE-MD project: survey on education in regulatory affairs

    As part of our work on the CORE-MD project we are running a short questionnaire on education in regulatory affairs. The questionnaire assesses what sort of training or education exists to inform healthcare professionals about regulatory affairs, and particularly in relation to the EU Medical Devices Regulation. With this survey we aim to identify educational needs relevant to the assessment of high-risk medical devices.

    If you are interested in this issue and can help us gather information on the existing training or education in regulatory affairs within your society, we would really appreciate if you could share or complete the survey. The survey will be open
    here until 10 December.

    This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 965246.
  • New structure for the Regulatory Affairs and Medical Devices Task force.

    Regulatory Affairs Committee will allow for cooperation on the longer term and will increase the BioMed Alliance power in the regulatory field. The taskforces will be able to work on an increasing number of topics while dividing the work according to the interest of the society representatives.
  • The BioMed Alliance named partner in the new CORE-MD project

    The CORE-MD project is a European project, funded under Horizon 2020, that aims at translating expert knowledge into advice for regulatory guidance and building expertise and Regulatory Science in the clinical community. The project will start in Spring 2021 and its duration will be 3 years. This is the first time BioMed Alliance has been named as a partner in a European project. For more information see the CORE-MD website.
  • Statement delay MDR Application Date

    The BioMed Alliance published a statement on 9 April welcoming the European Commission’s proposal to postpone the application date of the Medical Devices Regulation (MDR) by one year, to 26 May 2021. The statement highlights several key elements that should be taken into account in the implementation process of the MDR.
    Read the statement here.
  • Medical experts united on 11 February 2019 to improve scientific scrutiny of evidence for approval of high-risk medical devices in the European Union

    On 11 February, experts from the Biomedical Alliance in Europe (BioMed Alliance) advised the Joint Research Centre (JRC) of the European Commission in Ispra, Italy, on the clinical evaluation of high-risk medical devices. See the press release for more information.
  • BioMed Alliance Recommendations on the role of Scientific bodies under the new EU medical device legislative framework

    The BioMed Alliance has provided recommendations and input to ensure that independent advice is available to regulators responsible for the new EU legislative framework for medical devices and in vitro diagnostics. Find more information here.
  • Workshop on medical devices registries - Providing evidence for regulators

    The BioMed Alliance together with the ESC and EFORT organised a joint workshop on Medical Device Registries on 17 June 2019 in Brussels. The meeting facilitated a discussion between EU regulators, healthcare professionals, industry and patient representatives on both regulatory and clinical needs in relation to medical device registries.

    For more information, see the workshop report.

  • BioMed Alliance Joint Letter with EPF and ESC calling for investment to ensure MDR is implemented on time

    The Biomedical Alliance in Europe released an open letter to EU Health Ministers with the European Patients Forum (EPF) and the European Society of Cardiology (ESC) on 7 June calling for urgent investment to ensure that the EU Medical Devices Regulation (MDR) is implemented on time. Find the open letter here
  • Participation MDCG Working Groups

    BioMed Alliance representatives also participate in different stakeholder working groups of the Medical Device Coordination Group, which advises the European Commission and helps ensuring a harmonised implementation of medical device regulations in member states.
  • European Commission recruits experts for evaluation medical devices

    The European Commission has opened a call for experts to be appointed as members of the expert panels for medical devices as described in the Medical Device Regulation. By participating, experts will contribute to ensuring the safety of medical devices. The call is open until 10 November 2019 for all eligible applicants with expertise related to medical devices. Read more here.

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