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STANDARDISATION - Mandates

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standardisation
565
2020-03-20
Yes


Title  
  M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 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 [REGUEST IS NOT VALID DUE TO THE REJECTION OF CEN AND CENELEC DATED ON 16.6.2020]

Object 
  To draft and revise harmonised standards in support of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 and on in vitro diagnostic medical devices.

Text 
  See attached document

Annex 
 None

Attachment 
 M565 EN.pdf (389 KB)

Eso 
 CEN
 CENELEC

Policy areas 
 Internal market

Subjects 
 None

Linked to other mandate(s) 
 None


Directives 
 Regulation (EU) 2017/745
 Regulation (EU) 2016/426