The European Commission (EC) has requested that the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) draft revisions to existing standards and create new standards in support of the EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR).
The EC’s Elżbieta Bieńkowska writes that the “harmonised standards need to be revised to take into account the requirements set out in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 and the need to specify the correspondence between the technical specifications included in the standards and the requirements of the Regulations they aim to cover. In addition, some additional standards developed at international level need to be adapted to the EU legal framework or some new standards need to be drafted.”
The draft standardization request has a deadline for feedback on 25 July, and for each of the regulations, the EC presents two lists of existing standards needing revisions and two lists for the development of new standards.
The standards address requirements for regulatory purposes on product development processes, including sterilization, biological evaluation, packaging, aseptic processing, clinical investigation and labeling, among others. Existing standards are to be revised for alignment to the MDR/IVDR framework, while other revisions should specify the crosswalk between the standards’ technical specifications and MDR/IVDR. Some new standards will also cover certain product development processes, but most relate to information manufacturers are to provide.
Annex I to the draft standardization request lists 57 existing standards in need of revisions in support of MDR, while Annex II lists 39 existing standards in support of IVDR. Both annexes also identify six and four standards to be drafted in support of MDR and IVDR, respectively.
Most of the deadline standards are set for 27 May 2024, which is one day after the application of IVDR. The first several deadlines coincide with the application of MDR on 26 May 2020, including a corrigendum on EN ISO 13485:2016/AC:2018 quality management system requirements.
The EC says its decision should cover “horizontal standards addressing the needs of the widest scope of different economic operators” and “allow a subsequent alignment of semi-horizontal and device-specific standards which may derive from or complement the horizontal standards.”
Yet “additional system or process standards may be also needed in the future,” the EC adds.
CEN and the Cenelec have one month from the day of their receipt of the EC’s draft standardization request to accept it. Annex III explains general and specific requirements that CEN and Cenelec are to follow to complete the work on the standards within the set deadlines. A new CEN-Cenelec joint work program is to be submitted to the EC as well.
The EC’s decision had been long awaited by industry. The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry recently explained the need for the harmonization of standards in a position paper
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746