Introduction
UK medical device approval process post-Brexit
CTDA process
CTDA in practice
Comment
Over the holiday period, there were numerous news and industry reports of shortages of lateral flow tests and polymerase chain reaction (PCR) tests due to increased testing and the surge in covid-19 infection rates in the United Kingdom.
While there are a number of reasons for the shortage, including increased global demand for testing, industry associations including the Association of British Healthcare Industries (ABHI) have suggested that the covid-19 test device approvals (CTDA) process has reduced the speed at which British suppliers may access the UK market, thereby reducing the number of tests that could be available in the United Kingdom.
The United Kingdom is, at present, continuing to rely on lateral flow tests mainly manufactured in China, and although some British manufacturers have obtained approval and Conformité Européenne (CE) marking in Europe, these test kits have yet to reach the UK market. However, the health secretary, Sajid Javid, has said that the government is taking action over the shortages on covid-19 tests and will triple the supply of lateral flow tests to 300 million per month by February 2022.(1)
UK medical device approval process post-Brexit
To sell medical devices in the European Union, a manufacturer of a medical device must obtain a CE mark for their product.
To obtain a CE mark for a medical device, the device must undergo a conformity assessment to demonstrate it meets legal requirements to ensure it is safe and performs as intended. Medical devices are regulated at EU member state level, but the European Medicines Agency is involved in the regulatory process.
Once a medical device meets the relevant standards required, manufacturers can place a CE mark on a medical device after it has passed a conformity assessment.
The conformity assessment usually involves an audit of the manufacturer's quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
Since the Brexit transition period ended on 1 January 2021, there have been a number of legislative changes, introduced through secondary legislation,(2) as to how medical devices are placed on the market in Great Britain (England, Wales and Scotland).
As part of those changes, a new route to market and product marking – UK conformity assessed marking (UKCA) – is available for manufacturers wishing to place medical devices on the Great Britain market. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.
The UKCA marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market. UKCA marking is not recognised in the European Union, European Economic Area or Northern Irish markets, so relevant products require a CE marking for sale in these markets.
However, part of the changes implemented into UK legislation includes that certificates issued by organisations designated by an EU country to assess the conformity of certain products before being placed on the market (notified bodies) will continue to be valid for the Great Britain market until 30 June 2023. Therefore, manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the Great Britain market until 30 June 2023. From 1 July 2023, a UKCA marking will be required to place a device on the Great Britain market.
The CTDA process was introduced in November 2021(3) following concerns over the existing validation process and the quality of some covid-19 tests that were being supplied, and supports action to remove poor- quality tests from the UK market.
Manufacturers or distributors supplying covid-19 tests in the United Kingdom must apply to the Department of Health and Social Care (DHSC) for approval and their product must meet the Medical Devices (Coronavirus Test Device Approvals) Regulations 2021. This includes covid-19 tests that may have obtained CE marks in Europe.
Once an application has been submitted along with the relevant fee, the DHSC will conduct a basic check to make sure the application contains the following information:
- manufacturer and product information;
- regulatory status;
- product performance;
- biosafety; and
- supplementary documents (eg, current version of the instructions for use, biosafety documents and evidence of performance characteristic).
The next stage involves a review to assess the evidence submitted by the supplier against a minimum required data set.
This assessment is said by the DHSC to prevent products that are below the expected standards from progressing to the market as set out in the regulations. The assessment is done in three steps:
- a scientific adviser reviews it;
- the desktop review assurance group assesses the submission; and
- the regulatory approvals committee then considers it.
The DHSC states that the aim is to have the results of any review to potential suppliers within 20 working days, though this may be longer if there is a high volume of applications. In circumstances where it is in the interests of public health, the DHSC will prioritise certain applications.
At present, the main providers of National Health Service lateral flow tests for home use include the Chinese brands Orient Gene, made by Zhejiang Orient Gene Biotech, and FlowFlex, made by Acon Biotech. It is recognised that Chinese manufacturers have more experience in lateral flow testing and the ability to scale up production far beyond British companies.
It is hoped that reliance on international suppliers will reduce, with Derby-based SureScreen Diagnostics being the first approved British supplier of lateral flow devices. SureScreen has committed to supplying 20 million lateral flow tests.
However, to address the shortages and some of the related issues, the ABHI has written to the UK Health Security Agency and recommended that:
- all suppliers with a valid CTDA application in progress are able to continue to supply over winter, with an extension of the ability to place on the market until at least Spring 2022. The ABHI has argued that due to the spread of the Omicron variant, lateral flow tests should be prioritised, and such an approach will help maintain continuity of supply and reduce the risk to public health; and
- tests that it can be demonstrated already satisfy MHRA requirements and have obtained CE marking in Europe, for example, should be sold in the United Kingdom without undergoing the CTDA process.
Although some reports suggest that in the longer term, the public may not be able to access free lateral flow tests as part of the UK government's plans for living with the virus, there is still likely to be an ongoing demand for the tests amongst high-risk settings such as care homes, hospitals and schools. It remains to be seen how the UK government will respond to the shortage of covid-19 tests, especially as domestic testing and international demand for testing increases.
One possible way forward in the short term would be to allow covid-19 tests that meet the relevant CE standards in Europe to be supplied in the United Kingdom while going through the CTDA process, to meet the current high levels of demand for testing. Once the outcome of the CTDA process is known or if demand for tests decreases, then, if approved, the relevant tests can either continue being supplied or they can be withdrawn. Further resource may be required to expedite the CTDA process in the short term, especially as restrictions in the United Kingdom are lifted in the coming weeks.
For further information on this topic please contact Anna Harley at Pinsent Masons by telephone (+44 20 7418 8250) or email ([email protected]). The Pinsent Masons website can be accessed at www.pinsentmasons.com.
Endnotes
(1) See, for example, "COVID-19: 'Great concern' amid shortage of lateral flow and PCR tests before New Year's Eve parties – as system may need to be 'constrained' further, UK News, Sky News".
(2) See Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) and Directive 93/42/EEC on medical devices.
(3) See The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.