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Scientific and technical assessment

Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs is normally not involved in the assessment of individual medical devices. However, its services closely follow new trends in science and technology with a view to adapting the regulatory framework.

Once a precise scientific question is raised, the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) is consulted.

E.g., the SCENIHR was consulted with a view to assessing the appropriateness of the risk assessment methodology for assessing the risks of nanomaterialspdf(500 kB). More focused on medical devices, the SCENIHR has delivered the following reports, one on mercury in dental amalgampdf(611 kB) one on the use of DEHP as plasticiser in medical devicespdf(693 kB) and one on the safety of reprocessed single-use devices.

When assessing new trends in science and technology, DG for Internal Market, Industry, Entrepreneurship and SMEs is assisted by the Working Group on New and Emerging Technologies in Medical Devices. This working group scans the horizon of new technologies, be they related to artificial organs or other advanced implants, minimal invasive surgery, telemedicine, radio-frequency identification, in vitro diagnostic devices or nanomaterialspdf(72 kB) Choose translations of the previous link .

Recent scientific opinions concerning Medical Devices

Ongoing Public Consultations

List of open public consultations