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A significant move on the way to the adoption of new regulations on medical devices: EU countries agreed on the general approach to the medical devices package.

  http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8485&lang=en&tpa_id=1061&title=Towards%2Dsafer%2Dmedical%2Ddevices

2022-04-08T18:20:47+01:00

Draft regulation on MD

The consolidated text of both MDR and IVDR prepared by the Luxembourg Presidency are available.   Please follow the link to access the revised consolidated text of the recitals and articles of the proposed Regulation on medical devices prepared by the Luxembourg Presidency with a view to the finalisation of a General Approach, thus completing [...]

2022-04-08T18:20:47+01:00
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