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.


This Taskforce is chaired by Professor Alan Fraser.
See the full list of members


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 is organising a joint workshop on Medical Device Registries on 17 June in Brussels. The meeting will facilitate 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 Save the Date and the draft programme.


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