Skip to content. | Skip to navigation

Sections
 

Medical Device Directives revision

This work EAMBES - European Alliance of Medical and Biological Engineering and Science is licensed under the Creative Commons License Attribution - Noncommercial - No Derivative Works 3.0 Unported .

The EU legislative framework regulating the placing on the market and the classification of medical devices is expected to be revised shortly.

The European Commission plans to present a revision proposal of the Medical Device Directives most likely during the second quarter of 2012. The document will then be discussed and possibly amended by the European Parliament and the Council of Ministers of the EU: these two institutions will have to agree on the final text, possibly in 2013, before it can become law.

The proposal of the European Commission is expected to take into great consideration recent health and safety-related issues, such as the PIP scandal, and will provide an occasion to draw policy makers attention on medical devices-related issues, such as the research and development behind these. There is also likely to be a move towards greater harmonization of market surveillance activities across Member States.

The Council of Ministers, the EU institution representing national governments, already expressed in June 2011 the need to foster innovation within the medical device sector as a way of meeting long-term societal challenges such as ageing population. This will provide EAMBES´ members with further opportunities to highlight the relevance of BME research, for example during the workshop hosted by Dr. Ulmer MEP in the European Parliament on 27th of March 2012.

 

Document Actions