A medical device doesn’t achieve its intended action by pharmacological, immunological, or metabolic means, but does include devices intended to administer a medicinal product or which
incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.

The MHRA

The MHRA has competence over medical devices in the UK, including manufacturing, marketing, and import. Manufacturers of medical devices intended for the GB market must register with the MHRA as from 1st January 2021.¹

If the manufacturer is outside of GB, then they must appoint a UK Responsible Person who is based in the UK. However, there are some certain grace periods for such MHRA registrations (the following has been reproduced from the official guidance:²)

  • Active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A products must be registered with the MHRA by 1st May 2021.
  • From 1 September 2021, Class IIb non-implantable medical devices, Class IIa medical device, IVD List B products and self-test IVDs must be registered with the MHRA.
  • From 1 January 2022 where they have not previously been required to register with the MHRA (manufacturer or Authorised Representative is not based in the UK) Class I medical
    device, custom-made devices, general IVDs and systems and procedure packs must be registered.

The Legislation

The Medical Devices Regulations 2002 (SI 2002 No.618, as amended) (UK MDR 2002) continues to have effect in Great Britain post-BREXIT as this law was implemented into UK law prior to 1 January 2021. However, the EU Medical Devices Regulation 2021 (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation 2021 (EU IVDR) which is due to come into forcefully in the EU on 26th May 2021 and 26 May 2022 respectively, will not automatically apply in GB, as they were not in force during the transition period.

CE Marking

Medical devices intended for diagnostic use must carry a CE mark to be sold on the UK and the EU markets.³ A CE mark is given to a product that has been deemed to be compliant with health, safety, and environmental requirements. Prior to Brexit, there was a recognition programme that meant a UKCE mark was valid in all EU member states. This has now changed. Medical devices for the UK market require a UK NB certificate and medical devices for the EU market require an EU-27 NB certificate.

The UK has introduced a new CA scheme. A UKCA is available from a list of approved bodies, as decided by the MHRA.4  Manufacturers can apply to any of these bodies to get a UKCA for their medical device. This will allow them to enter the GB market only.

For medical devices that were CE marked under the old system, their certification remains valid for the GB market until the end of 2021. From 2022 onwards, a UKCA will be needed to sell products on the GB market for diagnostic use. If alterations are made to the medical device, then an application will need to be made for a new UKCA certificate. This will make the old CE certificate redundant.

UKCA is not recognised in the EU. A separate application for an EU-27 CE mark will be necessary if the medical device is being placed on the EU market post-Brexit. This can be obtained by applying to one of the EU-27 NB. Medical devices that were granted a CE mark by a UK body prior to Brexit remain valid until the end of 2021. From 2022 onwards, an EU-27 NB will need to issue a certificate for continued sale on the EU market. If the medical device is approved for both the UK and EU markets, it is allowable for the product to display both marks simultaneously.

We hope you found this brief article interesting.

The procedure for obtaining CE marking and registration of a medical device is intricate. This article does not constitute legal advice. There are many areas which need to be addressed.

Please do feel free to reach out to Wendy Lloyd-Goodwin at Life Science Law with any queries on Medical Device Regulations.

© Life Science Law 3rd May 2021.

1 Medical Device Regulations 2002.
2 Register medical devices to place on the market – GOV.UK (www.gov.uk)
3 A medical device to be used in a research setting does not carry a CE mark requirement.
4 Approved bodies for medical devices – GOV.UK – GOV.UK (www.gov.uk)