- Regulatory framework
- Specific areas of development
- Market surveillance and vigilance
- Scientific and technical assessment
- Other related policies
- Dialogue between interested parties
- International Cooperation
Scientific and technical assessment
Directorate General Health and Consumers 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 nanomaterials [487 KB]. More focused on medical devices, the SCENIHR has delivered the following reports, one on mercury in dental amalgam [596 KB] one on the use of DEHP as plasticiser in medical devices [676 KB] and one on the safety of reprocessed single-use devices.
When assessing new trends in science and technology, DG Enterprise and Industry 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 nanomaterials [70 KB] .