MDR compliance and Regulation (EU) 2023/607 | Joe Hagan-Brown

We knew it was coming. The publishing of the EU regulation 2023/607 amending the MDR and IVDR transitional arrangements, and allowing MDD and AIMD (directive) certificates to live on beyond 2024, was anticipated given the known concerns regarding Notified Body resource. The transitional timescales for IVDR had already been amended by regulation (EU) 2022/112, and so regulation (EU) 2023/607, understandably was more MDR focused. This is also where the major resource issues are being seen. 

Since the publication in the official journal of the amending regulation 2023/607, much of the talk has been regarding the extension of the life span of the outgoing directive certificates. These can now be used to market medical devices in Europe for over 5 years more in the case of class Is, Im, IIa and IIb devices. 2027 and 2028 may now seem like a long way away for manufacturers who were faced with imminent loss of market access if their MDD certificate had expired without the MDR extension being implemented. However it’s really important to understand the extensions provisions, and the timescales involved, and all the implications of applying it, before we conclude; crisis averted, and lets get back to business selling devices rathe than getting ready for MDR. 

This is the point we at MedRAS really want to stress. MDR has not gone away, and whilst the temptation may be to kick the can down the road now, in reality, all manufacturers have at best 1 year from May 2023 to be MDR compliant (if they are not already), if they wish to use the MDR extension in order to keep selling devices, using their ageing/resurrected directive certificate.

We have produced a one pager explanation of the key criteria and conditions which apply if you want to use the MDR extension. Note this infographic aims to keep things as simple as possible. The key points we would highlight in this article are:

  • General conditions which must be met by any manufacturer wishing to keep using a directive certificate by making use of the extension include complying with parts of the MDR as early as May 2024 (e.g. the manufacturer must have an MDR compliant quality management system by May 2024)
  • They also include the requirement for the manufacturers notified body to check that the requirements of the Directive, and also any applicable MDR requirements have been fulfilled by the manufacturer.
  • the full list of criteria and conditions is available in the one pager which you can download here.

The only point at which manufacturers should rest from their MDR journey is after they have obtained an MDR certificate. Until this point, there remains an urgency for MDD certified manufacturers to be MDR compliant, as soon as May 2024 (12 months from the time of writing), regardless of whether their directive certificate is valid/soon to expire, or has already expired.