COVID-19 has resulted in the rise of manufacture and development of testing devices, with a number of factors to consider before placing these on the market.
Existing regulatory framework
The current UK regulatory framework relevant to medical devices is primarily the Medical Devices Regulation 2002 (MDR).
COVID-19 testing kits are considered to be in vitro diagnostic devices, which are a category of medical devices. For a medical device to be placed on the market, it must be safe to use and compliant with the MDR. It must also have a valid CE mark, which means that the underlying conformance assessment has been successfully completed by the manufacturer according to the required legal criteria. CE marks are not issued by the Medicines and Healthcare products Regulatory Agency (MHRA); they are placed on the product by the manufacturer following registration with a competent authority such as the MHRA.
These regulatory requirements aim to ensure that the products do not compromise the safety of patients and users and are designed and manufactured to achieve the performance specified by the manufacturer for the stated purpose.
CE marking will be dealt with differently in Great Britain post-Brexit. See further here.
Overview of requirements
A number of so-called Target Product Profiles (TPPs), which are similar to product standards, have been developed by the MHRA and Department of Health and Social Care (DHSC). The aim is to help manufactures design and deliver COVID-19 tests that might be useful in contributing to the UK testing strategy (available here).
Manufacturers who think they meet the requirements of a specific TPP, or if it does not match the specifications of the TPP but looks promising, may submit a proposal via the DHSC portal (available here). However, keep in mind that the portal no longer accepts applications for antibody tests. The DHSC has a set process for the evaluation of diagnostic tests for COVID-19. If the test fulfils the DHSC evaluation process but does not yet have a CE mark, manufacturers can apply for a derogation from such requirement, which is considered by the MHRA.
The derogation process includes sending an application to the MHRA with specific information including instructions for use; the clinical evidence base; details of other regulatory approvals; confirmation of completion of DHSC evaluation process; details of the product; expected time to gain CE certification; and more. A full list of requirements can be found here. Evidence that the device performs as intended is paramount for the derogation process.
Self-testing kits for COVID-19 (as opposed to self-sampling kits) are not currently available to the general public. The MHRA have made it clear that there are currently no COVID-19 self-test kits in the UK suitable for home use and it is illegal to supply them for use by members of the public. This is because no COVID-19 self-test kits currently have a CE mark, although this may change in future.
The requirements mentioned in this article are continuously changing and developing. Please do not hesitate to contact Pieter Erasmus or Rumana Khanom should you require any assistance or have any further questions.