BioMed COREMD

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 10 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

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