The EU has approved a revised Standardisation Request requesting the European standards body CEN to produce Harmonised Standards which will give a presumption of conformity to the European Medical Device Regulations MDR 2017/745 and IVDR 2017/746. CEN is now awaiting the official Standardisation Request from the European Commission. However, it is by no means certain that the revised Standardisation Request will be approved by CEN (given that the original Standardisation Request was rejected). If the Standardisation Request is not accepted by CEN then it is unlikely that the EU will revise the Standardisation Request a second time which could mean that we would not have Harmonised Standards for the MDR and the IVDR for at least another two years. On the other hand, if the Standardisation Request is approved by CEN, there are a number of standards which are ready to go and could be harmonised within weeks of the approval of the Standardisation Request.
So why would CEN reject the revised Standardisation Request and how likely is this to happen? The Standardisation Request places a number of restrictions around what information a Harmonised Standard may and may not contain; for example, a requirement that a Harmonised Standard does not contain any definition that is already defined in the regulation. These restrictions could make it very difficult to adopt an existing international standard (ISO or IEC) as the European Harmonised Standard. At present, there are also difficulties with the process whereby EU-appointed Health and Safety (HAS) consultants review standards submitted by CEN for harmonisation. At a CEN committee meeting on Medical Device standards held on 1st April, strong views both in favour and against accepting the Standardisation Request were expressed by committee members. No date has yet been set by CEN for the vote on the Standardisation Request as it has not yet been received by CEN. It was resolved that CEN would continue to work with the EU to try to resolve any outstanding issues whilst awaiting the official Standardisation Request from the European Commission.
Update provided by our Tutor & Industry Expert, John Lafferty
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