The cons
olidated 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 the partial General Approach reached at the meeting of the Council (EPSCO) on 19 June 2015.
URL: http://data.consilium.europa.eu/doc/document/ST-12040-2015-REV-1/en/pdf
Please follow the link to access the consolidated text of the annexes to the proposed Regulation on medical devices prepared by the Luxembourg Presidency with a view to the finalisation of a General Approach, thus completing the partial General Approach reached at the meeting of the Council (EPSCO) on 19 June 2015.
URL: http://data.consilium.europa.eu/doc/document/ST-12040-2015-ADD-1/en/pdf
Please follow the link to access the consolidated text of the recitals and articles of the proposed Regulation on in vitro diagnostic medical devices prepared by the Luxembourg Presidency with a view to the finalisation of a General Approach, thus completing the partial General Approach reached at the meeting of the Council (EPSCO) on 19 June 2015.
URL: http://data.consilium.europa.eu/doc/document/ST-12042-2015-INIT/en/pdf
Please follow the link to access the consolidated text of the annexes to the proposed Regulation on in vitro diagnostic medical devices prepared by the Luxembourg Presidency with a view to the finalisation of a General Approach, thus completing the partial General Approach reached at the meeting of the Council (EPSCO) on 19 June 2015.
URL: http://data.consilium.europa.eu/doc/document/ST-12042-2015-ADD-1/en/pdf