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UK to align with IMDRF on IVD classification

Published by Alec Denniff, Medical Device Paralegal on

On June 26 2022, the UK government published its response to the Medicines and Healthcare products Regulatory Agency (MHRA) Consultation on the Future Regulation of Medical Devices in the UK.

As stated by the MHRA, the UK Medical Devices Regulations (UK MDR) needs revision to ensure that the UK is a “focus for innovation, and becomes the best place to develop and introduce innovative medical devices.” The MHRA expects that the new regulations will foster “proportionate regulation, supporting businesses through access routes that build on synergies with both the EU and wider global standards.” But how exactly will the new regulations differ from the current UK MDR? Perhaps the biggest area of change is expected to be around how in-vitro diagnostic (IVD) medical devices are classified, and therefore placed on the market. 

Currently, IVDs are grouped into four categories:

  • IVDs which are listed in Part IV of the UK MDR 2002 (as modified by Part III of Schedule 2A to the UK MDR 2002) are categorised as Annex II List A. This includes certain reagents for determining blood groups (e.g. ABO, anti-Kell), as well as reagents which detect, confirm or qualify markers of HIV, HTLV and hepatitis. 

  • IVDs which are listed in Part IV of the UK MDR 2002 (as modified by Part III of Schedule 2A to the UK MDR 2002) are categorised as Annex II List B. This includes, amongst other devices, those intended for determining anti-Duffy and anti-Kidd blood groups, HLA tissue groups DR, A and B, as well as devices specifically used for evaluating the risk of trisomy 21. 

  • IVDs for use by lay persons in their home environment, are categorised as IVDs for Self Testing, except where covered above. 

  • General IVDs are all IVDs other than those covered above.

These classification rules currently allow roughly 80% of IVDs to be placed on the market on the basis of self-declaration, i.e. where the manufacturer self-declares compliance to the regulatory requirements without involvement of any third party conformity assessment body.

The government intends to amend the IVD classification rules, using a series of classification rules which will align the UK more closely with those used by the International Medical Devices Regulators Forum (IMDRF). Adoption of a series of rules aligning with the IMDRF approach would mean that IVDs will now be classified as Class A (low risk), to Class D (high risk). Whilst both the EU approach and the IMDRF approach utilise the same classification basis (Classes A-D) there are differences in the actual classification rules, resulting in the potential for different classifications in different jurisdictions.  

A number of differences are noted between the two classification rulesets:

  • Rule 1 of the IMDRF approach does not classify as Class D those IVDs which determine the infectious load of a life-threatening disease where monitoring is critical in the process of patient management. Such devices are explicitly called out by Rule 1, third indent of the EU IVDR.

  • Rule 3, concerning IVDs for determining infective disease status or immune status and where there is a risk of an erroneous result, is slightly broader than its EU equivalent, catching not only those which lead to a patient management decision resulting in an imminent life-threatening situation for the patient or patient’s offspring, but also those which lead to a patient management decision resulting in severe disability. The latter is not covered by EU IVDR Rule 3 (e). 

  • Rule 3, concerning IVDs for monitoring the levels of medicines, substances or biological components, is slightly narrower in scope than its counterpart in EU IVDR Rule 3 (j), only covering those instances where an erroneous result could lead to a patient management decision resulting in an immediate life-threatening situation for the patient or patient’s offspring. 

  • Rule 4 of the IMDRF approach aligns, in effect, with the EU approach, but there is an important difference in the operation of the rule. Whilst Rule 4 explicitly lists those devices which fall into a lower class (i.e. devices for the detection of pregnancy, fertility testing, determining cholesterol level), the IMDRF approach uses a principles-based approach (i.e. those which do or do not determine a critical situation). The latter is similar to the Australian approach to classifying IVDs for self-testing, which examines whether the result does or does not determine a serious condition, ailment or defect. 

Whilst the new classification rules will largely follow the structure used by the IMDRF, the UK government also plans to differ from the IMDRF in some areas. For example, as far as IVDs to be used as companion diagnostics are concerned, the UK government intends to introduce classification rules specifically for such devices. Under the IMDRF approach, such devices are Class 3, whereas the government’s responses suggest a separate series of rules for companion diagnostics will be introduced. 

The MHRA’s plan is that new regulations will come into force from 1 July 2024. Initially 1 July 2023, the date has been postponed a year to provide sufficient time for drafting of the regulations. However, the response outlines soft transitional arrangements (subject to certain limitations), for legacy devices, similar to the roll out of the EU MDR and IVDR. The prospect of soft transitional periods will come as a relief for manufacturers queuing with the limited number of Approved Bodies in the UK, particularly given the expected increase in IVDs requiring third party conformity assessment as a result of up-classification. The next step is for draft legislation implementing these changes to be published in the coming months. 

If you are interested in learning more about how these changes may affect your device’s classification, please contact any member of the team or register your interest below. Our AI-powered guide can help unlock the regulatory maze, and will take you from a state of confusion to a place of clarity and confidence on your next regulatory steps.