On June 26, 2020, CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation) rejected the implementing decision M/565 of the European Commission (EC) published on May 15, 2020.
The decision required CEN and CENELEC to standardise a series of existing regulations and new regulations to be drawn up as regards Medical Devices, in support of the Medical Devices Regulation MDR (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746.
What the European Commission’s implementing decision M/565 provided for
The main text of the implementing decision M/565, published in the Commission’s “Standardisation Mandates database”, consists of a series of articles which explain the objectives of the request, establish the required standardisation activities, the requirements relating to the work programme and communication, the validity of the standardisation request and the expiry of the existing standardisation mandates in the Medical Devices field.
In addition, there are three annexes:
- Annex I lists existing standards to be revised, new standards to be developed and the deadlines for their adoption in the MDR;
- Annex II lists existing standards to be revised, new standards to be developed and the deadlines for their adoption in the IVDR;
- Annex III established some general and specific requirements for the standards listed in annex I and II.
Standardisation request for MDR and IVDR rejected: and now?
CEN and CENELEC gave reasons for their refusal of EC Implementing Decision M/565 on the annex III requirements, in particular as regards the interrelation between international and European standardisation.
Probably, the European Commission will work on a new request to negotiate with CEN and CENELEC and reach a decision shared by all stakeholders.
MDR (EU) 2017/745 and IVDR (EU) 2017/746: how to best prepare?
The best solution to be ready for the implementation of new regulations on MDR (EU) 2017/745 and IVDR (EU) 2017/746 Medical Devices is to rely on expert consultants. Thema offers strategic-regulatory consulting services for companies operating in Medical Devices and IVD field.
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