Following Brexit, the UK has moved from European Union (EU) medical device regulations to its own regulatory regime. This has introduced the use of the UKCA (UK Conformity Assessed) marking rather than the CE mark currently used in the EU. CE marking will continue to be recognised in the UK until 30th June 2023 and from the 1st July 2023, medical devices will require the UKCA mark to be placed on the market in Great Britain (England, Wales, and Scotland) and either the CE mark or a UKNI mark for the Northern Ireland market.
The United Kingdom In-vitro Diagnostics market is large and growing. The population of the UK is around 70 million and the UK in-vitro diagnostic market was valued at $3.1bn in 2021 and is expected to reach $5bn million by 2027, registering an annual growth rate of nearly 8% during this period. From a lateral flow perspective, the UK has been a significant adopter of lateral flow technology particularly during the COVID-19 pandemic where lateral flow COVID-19 antigen testing was a key foundation of the UK Government’s pandemic strategy.
So, if your lateral flow product is already in the UK market under CE marking or you are thinking of launching your product into the UK, then read on. In this article we set out the main changes and implications. The changes are complex but the good news is help is at hand and Abingdon Health’s regulatory team is already supporting a number of LFT manufacturing services clients through this process.
UK Regulatory Changes – A Summary
For continued access to the UK market, medical devices must achieve UKCA marking by the end of June 2023, however, in the recent consultation on the future regulation of medical devices in the United Kingdom, the Government is considering a transitional period where devices with a valid CE mark or UKCA mark will benefit of up to 5 years to transition to the new.
This transitional period would be welcomed by many. However, this should not be considered a time to relax and sit back. With only 3 UK Approved Bodies available at the time of writing, capacity to assess products is limited and transitioning to UKCA marking could be lengthy process. Manufacturers should act now to avoid non-compliance later down the line.
The current requirements for UKCA marking follow the In Vitro Diagnostic Directive (IVDD) and all devices are required to be registered with the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency) which is responsible for ensuring that medicines and medical devices work and are acceptably safe. This registration can be done by any UK-based manufacturer. However, manufacturers located outside the UK are required to appoint a UK Responsible Person to act on the manufacturer’s behalf.
To obtain UKCA marking devices need to follow one of the following routes. Once UKCA marking has been granted, product owners can apply to have their device registered with MHRA.
- Devices that meet the criteria under the IVDD for self-certification can also achieve UKCA marking through self-certification.
- Any device requiring notified body review under the IVDD will also require review by a UK Approved Body prior to applying the UKCA mark. The UKCA and UKNI marks (conformity marking for products placed on the market in Northern Ireland) are not recognized in the EU.
The Impact of IVDR
UKCA marking is not the only change in medical device regulations. In short, the EU Regulatory landscape is also in a state of dramatic change with the introduction of the IVDR (In Vitro Diagnostic Regulation) in May 2022.
The IVDR brings many challenges to device manufacturers, in particular many devices require third-party oversight from notified bodies for the first time, rather than simply being ‘self-certified’ by manufacturers. A transitional arrangement has been granted however, with a shortage of notified bodies, time is not on the manufacturers side. The IVDR changes also need detailed consideration. See more detail on this in our article on the impact of IVDD to IVDR changes on lateral flow test owners.
Support Through the Regulatory Pathway
The combination of the UKCA marking and the implementation of IVDR means there is a significant amount of planning and consideration needed by product owners. Either to re-certify lateral flow test products in the growing UK IVD market or to launch products in the UK for the first time.
For non-UK companies, a UK Responsible Person is required to support and help manage the UK submission for lateral flow products. Given the need to separately submit for UK-regulatory-approval with the MHRA, having an experienced UK Responsible Person to guide you proactively and expertly through this process is invaluable.
Whilst there is a transition period for any new medical device looking to access the UK market, action is required “now” and regulatory support is essential to ensure a smooth process.
Below are areas where Abingdon Health can help you plot a way through this regulatory pathway:
- To sell products in the UK you will need a UK Responsible Person. Abingdon Health could perform this role, if you wished, and manage the submission process into the UK regulatory authorities.
- In helping build the technical documentation to meet UK Regulations
- Support post-market surveillance activities under IVDD, as currently required in the UK.
- Managing the other areas required to transition to UKCA; including areas such as packaging and labelling.
- Generating the clinical performance data; where support is required, Abingdon Health can facilitate and plan lateral flow test clinical trials in order for your device to meet specific market and regulatory requirements.
The Key Take-Away
The UK lateral flow market is large and growing but access to this market is in a period of transition. The regulatory landscape is changing dramatically in the UK, as it is in the European Union, with the implementation of the UKCA mark from June 2023. When applying for a UKCA mark, lateral flow product owners need to know what is required to meet these new regulations.
Through Abingdon Health’s in-house regulatory expertise, we can support this process and make your product introduction or re-certification as smooth as possible. Contact a member of our team to learn more.
Authored by Candice Vendettuoli, Abingdon Health’s Head of QARA.