The European Commission has notified today CEN and Cenelec of the Standardisation request in the Implementing Decision C(2021) 2406, which will serve as the basis for future harmonised standards in support of Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR].
Europan standardisation organizations CEN and Cenelec have one month to respond to the European Commission’s request following Regulation (EU) No 1025/2012. Please be informed that the first standardisation request in support of the MDR and IVDR set out in Implementing Decision C(2020) 253212 was not accepted.
As per Article 8 of MDR and IVDR using harmonised standards published in the Official Journal of the European Union grants the presumption of conformity with relevant legal requirements, which are covered by the harmonised standard.
According to the European Commission:The harmonised standards should include detailed technical specifications in relation to the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746, especially with respect to the design and manufacture of devices, risk management and the obligations on economic operators and sponsors, including those relating to quality management systems, risk management, clinical investigations and performance studies, and clinical evaluation and clinical evidence. They should also indicate clearly the correspondence between the technical specifications and the requirements they aim to cover.
The European Commission has requested CEN and Cenelec:
- 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.
- 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.
Commission Implementing Decision C(2021) 2406 of 14.4.2021 containing the text of the standardisation request can be found here.