26 Mar 2020

The global need for more COVID-19 testing is huge – for those biotech companies and manufacturers looking to develop test kits in the UK, here are the key legal points to be aware of before launching your test kits to the market.

THE LATEST ARTICLE ON COVID-19 TEST KITS CAN BE SEEN HERE.

The relevant regulator in the UK is the Medicines and Healthcare Products Regulatory Agency (MHRA), who, together with Public Health England (PHE), is working with companies to help them place newly-developed COVID-19 test kits on the market.

Generally, COVID-19 test kits can be split into two groups: those intended for professional use (e.g. by doctors and other healthcare professionals in clinics and hospitals) and those intended for self-testing (i.e. for use by individuals at home). Whilst both types of test kit are regulated under Directive 98/79/EC on In Vitro Diagnostic Medical Devices, a COVID-19 test kit intended for professional use would be regarded as a general in vitro diagnostic (IVD) medical device, whilst a test kit intended for home use would be regarded as  a self-test IVD medical device.

Section 3 of the MHRA’s In Vitro Diagnostic Medical Devices: Guidance on Legislation document provides guidance on the relevant legislation and sets out what you would usually need to do before making your test kit available to the UK market.

Your kit is for professional use here’s what you should know:

If your kit isn’t CE marked yet

Whilst a CE mark would ordinarily be required to show that the medical device in question has met the relevant health and safety protection standards required in the EU, CE marks take some time to be obtained. Given the exceptional circumstances relating to the coronavirus pandemic, the MHRA understands that manufacturers of COVID-19 test kits may be looking to obtain fast-track regulatory approval. It may even be the case that the MHRA authorises you to supply a non-CE marked device by way of derogation in the interest of the protection of health whilst your product undergoes the CE marking process.

The first step is to submit your COVID-19 test kit for professional use to PHE for review. This is done by submitting your product proposal to PHE at coviddiagnostics@phe.gov.uk.

If PHE considers that your test is suitable for use in the UK, you can then apply to the MHRA for approval to supply a device that does not comply with the regulations. To obtain such approval, you must send your application to devices.compliance@mhra.gov.uk and include the following information:

  • details of the product(s), including model name and description
  • reasons why the product does not have a valid CE mark
  • clinical justification for requesting a derogation for the product
  • explanation of any alternative products on the market and reasons why using these products would not be appropriate
  • numbers of product likely to be supplied under the derogation plus an indication of how widely used the product is
  • expected time to gain/re-gain CE certification

The MHRA might ask you for more information once they’ve received your application. Please be aware that you would be expected to have evidence that the device performs as intended i.e. confirmation that PHE considers that the test kit is suitable.

If your kit is already CE marked

If you are a manufacturer or supplier of a professional use test kit that already has a CE mark, the MHRA has recently published a form that should be completed and sent to Devices.Regulatory@mhra.gov.uk. The MHRA will then tell you if you can place your test kit on the market.

Your kit is for home testing – here’s what you should know:

For self-testing kits a CE mark is required, together with an additional certificate, known as an EC certificate.

As at 26 March 2020, current MHRA guidance confirms that there are no CE marked tests for home use and that it is illegal to supply such products. Furthermore, whilst some manufacturers appear to be selling products for the diagnosis of COVID-19 infection in community settings, such as pharmacies, PHE’s current view is that use of these products is not advised.

PHE is leading on evaluating the performance and suitability of self-tests for COVID-19 and this includes working with the MHRA to define a specification for a self-test, which will be published in due course.

If you have any questions about evaluations of self-test kits, they should be sent to PHE at coviddiagnostics@phe.gov.uk.

If you have any questions, or need further advice on how to get your product to market, please get in touch – the team would be happy to help.

Please note: due to the evolving nature of this situation, the MHRA’s guidance in this area is continually being updated, so please do keep checking back here as we intend to keep you informed of the latest guidance as it is published.

In this fast-changing situation, we recommend you keep up to date with our latest Coronavirus insights and advice.

UPDATE – 14 APRIL

MHRA is no longer accepting applications to place test kits on the market. The government has developed specifications for COVID-19 tests which can be viewed here. The Department of Health and Social Care has also issued a policy paper covering the scaling up of coronavirus (COVID-19) testing programmes which can be viewed here.