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DG SANTE Annual work plan for 2015


DG SANTE published on 2 June 2015 its annual work plan for 2015, which sets out the priorities and actions to be undertaken, including the allocation of resources, to implement the third Programme of the Union’s action in the field of health (2014-2020).

Of particular interest are the actions related to medical devices and health technology assessment, which include:

A more developed and coordinated Market surveillance of medical devices by Member States´ competent authorities.

Maintenance and development of the European medical devices database (EUDAMED) and development of the future EUDAMED following the adoption of the new Regulations on medical devices. EUDAMED will allow the exchange of legal information related to the application of European Union Directives on medical devices between the Commission and the competent authorities in the EU Member States.

Communication and publication actions to promote the understanding and correct implementation of the requirements and risks relating to medical devices following the adoption of the new Regulations.

Technical and scientific opinions and advices allowing improved coordination and resource sharing between Member States and enhanced transparency regarding medical devices on the EU market.

Support cooperation at scientific and technical level between Health Technology Assessment Bodies to ensure the sustainability of the joint work after EU funding under the Health Programme ends.

The future EUDAMED is due to be launched in the first semester of 2015, second semester in the case of the actions regarding the correct implementation of the new MDR and IVR, showing once again how keen the Commission is on seeing these regulations adopted as soon as possible.  

For more information:

http://ec.europa.eu/health/programme/docs/wp2015_en.pdf

http://ec.europa.eu/health/programme/docs/wp2015_annex_en.pdf

 

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