Decisione di esecuzione Commissione del 14.4.2021 COM(2021) 2406 final

Decisione di esecuzione Commissione del 14.4.2021 / COM(2021) 2406 final

Commission implementing Decision 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
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Article 1 Requested standardisation activities

1. The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are requested to revise the existing harmonised standards listed in Table 1 of Annex I to this Decision and to draft the new harmonised standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/745 for medical devices by the deadlines set in that Annex.

2. CEN and Cenelec are requested to revise the existing standards listed in Table 1 of Annex II to this Decision and to draft the new harmonised standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/746 for in vitro diagnostic medical devices by the deadlines set in that Annex.

3. The standards referred to in paragraphs 1 and 2 shall meet the requirements set out in Annex III.

ANNEX I
List of existing standards to be revised and list of new standards to be drafted as referred to in Article 1(1)

ANNEX II
List of existing standards to be revised and list of new standards to be drafted as referred to in Article 1(2)

ANNEX III
Requirements for the standards referred to in Article 1
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