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STANDARDISATION - Mandates

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standardisation
575
2021-03-12
Yes


Title  
  M/575 COMMISSION IMPLEMENTING DECISION C(2021) 2406 of 14.4.2021 on a standardisation request to the European Committee for Standardization 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

Object 
  The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are requested to revise the existing harmonised standards and to draft new harmonised standards in support of Regulation (EU) 2017/745 for Medical Devices and in support of Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices.

Text 
  See attached document

Annex 
 None

Attachment 
 M575 EN.pdf (478 KB)

Eso 
 CEN
 CENELEC

Policy areas 
 Internal market

Subjects 
 None

Linked to other mandate(s) 
 None


Directives 
 Regulation (EU) 2017/746
 Regulation (EU) 2017/745