The UK’s Fast-Growing Diagnostics Market
UKCA & CE Marking in IVD
MHRA: The Designating And Competent Authority In The UK
Key UK Regulatory Considerations
Key Questions To Ask Yourself
Abingdon Can Help

If you’re already selling a diagnostic device in the UK (e.g. lateral flow test or ELISA) or planning to do so, then you need to be aware of the impact of recent regulatory changes in the UK following Brexit. This article outlines the new UK Conformity Assessed (“UKCA”) marking process and, also, the key questions you should be asking today in order to meet these new requirements.

The UK’s Fast-Growing Diagnostics Market

The UK diagnostic market is worthy of consideration as an early-adopter of lateral flow, and in-vitro diagnostic (“IVD”) technology in general. It is a large and growing market; the UK population being over 67 million with the UK IVD market worth over £1 billion – and growing at double-digit pace. For many North American companies, it represents an attractive entry point (with a common language, for example) into the European market.

UKCA & CE Marking in IVD

UKCA marking is the product marking used for products being placed on the market in Great Britain (England, Scotland and Wales) and is replacing CE marking for medical diagnostic products. Different rules apply in Northern Ireland to those in Great Britain where CE marking will continue to apply.

UKCA marking requirements for IVD devices are based on the Directive 98/79/EC which have been modified by Schedule 2A to the UK MDR 2002. In essence, as set out in Annex I of the Directive:

“The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.”

MHRA: The Designating And Competent Authority In The UK

The Medicine and Healthcare Products Regulatory Agency (“MHRA”) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

The MHRA has designated approved bodies, which are organisations that can conduct conformity assessments against the relevant requirements for the purposes of UKCA marking.

Key UK Regulatory Considerations:

1.   From 1st July 2024, UKCA marking is required for new devices placed onto the Great British market. The original implementation date was 1st July 2023 however, this has recently been extended.

2.   CE marked products will continue to be recognised in Great Britain and certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30th June 2024. All devices previously registered with the MHRA under CE marking prior to this date will benefit from a transitional period of up to 5 years.

3.   All medical devices, including in-vitro diagnostic medical devices (IVDs), will need to be registered with the MHRA before they are placed on the Great Britain market. This is a requirement today and you cannot rely on a CE marking.

4.   You will need to appoint a UK Responsible Person to act on your behalf. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings. The responsibilities of the UK Responsible Person include registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market. Other obligations of the UK Responsible Person include:

  • ensuring that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; and
  • keeping available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.

Key Questions To Ask Yourself:

  • If your product is for sale under CE marking in the UK, have you registered it with MHRA?
  • If you are planning to register your product, do you have the skills in-house to do this?
  • If you aren’t based in the UK, do you have or will you need a UK Responsible Person in place to do either of the above?
  • If you are planning to UKCA mark your product, is your technical file prepared? Has it been reviewed against the requirements of the UK regulations?
  • Do you require a MHRA approved body review of your application?
  • Do you have a post-market surveillance process in place?

Abingdon Health Can Help You

Abingdon Health’s in-house regulatory team has been working with our lateral flow development and manufacturing clients to prepare their assays for UKCA marking for a number of years, gaining vast knowledge and expertise about global regulatory and approval processes.

We can provide full-service support to build your technical file, manage clinical trials, be your UK Responsible Person, and ensure post-market surveillance is in place. Wherever your IVD is in its lifecycle, whether it be lateral flow, ELISA or other methods, contact us to see how we can help.