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Draft standardisation medical devices and in vitro diagnostic medical devices

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Draft standardisation request as regards medical devices and in vitro diagnostic medical devices

Draft standardisation request as regards medical devices and in vitro diagnostic medical devices

EU, October 2020

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 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 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 new 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.
4. CEN and Cenelec shall provide the Commission with the titles of the requested standards in all official languages of the Union.

Article 2 Work programme

CEN and Cenelec shall prepare a draft joint work programme indicating all the standards listed in Annexes I and II, the responsible technical bodies and a timetable for the execution of the requested standardisation activities in line with the deadlines set out in those Annexes. CEN and Cenelec shall submit the draft joint work programme to the Commission by [insert date – 6 weeks after notification of this Decision by the Commission]. CEN and Cenelec shall inform the Commission of any amendments to the joint work programme.
CEN and Cenelec shall provide the Commission with access to an overall project plan and inform the Commission of any amendments to the joint work programme.

Article 3 Reporting

1. CEN and Cenelec shall report annually to the Commission on the execution of the standardisation request referred to in Article 1 indicating the progress made in implementation of the work programme referred to in Article 2.
2. CEN and Cenelec shall submit the first annual joint report to the Commission by [insert date – 12 months after notification of this Decision by the Commission].
3. Subsequent annual reports shall be submitted to the Commission by 31 October each year.
4. CEN and Cenelec shall provide the Commission with the final report by 30 June 2024.
5. Without prejudice to the reporting obligations set out in paragraphs 1 to 4, CEN and Cenelec shall promptly report to the Commission any concerns relating to the scope of the standardisation request referred to in Article 1 and the deadlines set in Annexes I and II.

Article 4 Harmonised standards

CEN and Cenelec shall include in each harmonised standard a clear and precise description of the relationship between its content and the corresponding safety and performance requirements set out in Annex I to Regulation (EU) 2017/745 or in Annex I to Regulation (EU) 2017/746 that it aims to cover. Each harmonised standard developed on the basis of the standardisation request referred to in Article 1 of this Decision shall refer to this Decision.
CEN and Cenelec shall include in each revised standard information on significant changes that were introduced in that standard.
CEN and Cenelec shall provide the Commission with the titles of the requested harmonised standards in all the official languages of the Union.

Article 5 Validity of the standardisation request

If CEN or Cenelec do not accept the standardisation request referred to in Article 1 within a month of receiving it, the request may not constitute a basis for the standardisation activities referred to in that Article.
This Decision shall expire on 31 December 2024.

Article 6 Expiry of existing standardisation mandates

1. The following standardisation mandates shall expire on 26 May 2021:
(a) BC/CEN/CENELEC/09/89 of 19 December 1991;
(b) BC/CENELEC/02/89;
(c) BC/CEN/03/91;
(d) M/023 - BC/CEN/03/023/93-08 of 5 August 1993;
(e) BC/CEN/CENELEC/029/96;
(f) M/295 of 9 September 1999;
(g) M/320 of 13 June 2002;
(h) M/321 of 13 June 2002;
(i) M/332 of 7 July 2003;
(j) M/333 of 23 October 2003;
(k) M/342 of 10 February 2004;
(l) M/432 of 24 November 2008;
(m) M/433 of 24 November 2008;
(n) M/467 of 19 May 2010.
2. The following standardisation mandates shall expire on 26 May 2022:
(a) M/252 of 12 September 1997;
(b) M/384 of 6 April 2006.
3. The following standardisation mandate shall expire on the date of adoption of the standardisation request referred to in Article 1:
(a) M/565 of 15 May 2020.

Article 7 Addressees

This Decision is addressed to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec).

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Tags: Marcatura CE Direttiva Dispositivi medici diagnostici vitro Abbonati Marcatura CE Regolamento Dispositivi Medici

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