COMMISSION IMPLEMENTING DECISION on a (SR) standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council

Requested standardisation activities
1. The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are requested to revise the existing standards listed in Table 1 of Annex II to this Decision and to draft new standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/746.

Table1:     List of existing standards to be revised and deadlines for their adoption
Table2:     List of new standards to be drafted and deadlines for their adoption

Estas tablas son las que puedes tomar como lista de normas armonizadas hasta su publicación en el DOUE. leer más…

COMMISSION IMPLEMENTING DECISION on a (SR) standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council

Requested standardisation activities
1. The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are requested to revise the existing standards listed in Table 1 of Annex I to this Decision and to draft new standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/745.

Table1:     List of existing standards to be revised and deadlines for their adoption
Table2:     List of new standards to be drafted and deadlines for their adoption

Estas tablas son las que puedes tomar como lista de normas armonizadas hasta su publicación en el DOUE. leer más…

Este es el nuevo sello que llevará la publicidad de productos sanitarios. Va asociada al código ético de FENIN que incluye las acciones publicitarais.