24 Jan UKCA marking for medical devices

On 1 January 2021, the post-Brexit transition period came to an end, meaning that the United Kingdom has now been outside the European Union for a year, which brings us closer to the official entry into force of the UKCA (United Kingdom Conformity Assessment). The UKCA Mark for medical devices is the certification that will replace the European CE marking. From 1 July 2023, medical device companies with products on the UK market will no longer be able to place their products on the market under the CE marking. It is very important that you start planning how you will obtain a UK Conformity Assessment.

The only exceptions to this are medical devices produced by manufacturers in Northern Ireland, which will be able to continue to sell CE marked devices in the UK after the deadline.

The current medical devices directives and regulations in force in the European Union are given effect in the UK through the Medical Devices Regulations 2002.

What are the requirements for CE marked products in the UK?

From 1 January 2021, there are a number of requirements that products marketed as medical devices in Great Britain (England, Wales and Scotland) must comply with:

Certificates issued by notified bodies recognised by the EU will remain valid for the UK market until 30 June 2023.

The EU no longer recognises the UK’s notified bodies.

UK Notified Bodies cannot issue CE certificates (except for the purposes of the “CE UKNI” mark, which is valid in Northern Ireland), and have become UK Approved Bodies.

A new route to market and product marking is available for manufacturers wishing to obtain UKCA marking for medical devices.

From 1 January 2021, all medical devices, including in vitro diagnostic (IVD) medical devices, marketed in Great Britain must be registered with the MHRA. There is a grace period for registration:

• Class III and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered by 1 May 2021.
• Other Class IIb devices and all Class IIa devices and Schedule B IVD products and self-testing IVDs must be registered from 1 September 2021.
• Class I devices, custom-made devices and general IVDs must be registered from 1 January 2022
• Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with authorised representatives based in Northern Ireland) must continue to register their devices from 1 January 2021.

When is it necessary to designate a UKRP?

Any manufacturer based outside the UK and placing a medical device on the market must appoint a single UK Responsible Person (UKRP) who will assume responsibility for the product in the UK, who must:

• Ensure that the declaration of conformity and the technical documentation have been drawn up and, where applicable, that an adequate conformity assessment procedure has been carried out by the manufacturer.
• Keep a copy of the technical documentation, a copy of the declaration of conformity and, where applicable, a copy of the relevant certificate, including amendments and supplements available for inspection by the MHRA.
• In response to a request from the MHRA, provide the MHRA with all information and documentation necessary to demonstrate compliance of a device.
• Where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device.
• Where they do not have samples of the device or access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with such a request.
• Cooperate with the MHRA in any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by the devices.
• Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
• If the manufacturer acts contrary to his obligations under this Regulation:
  • terminating the legal relationship with the manufacturer
  • inform the MHRA and, if applicable, the Approved Body concerned of such termination.
• It is possible for an importer or distributor to act as a responsible person in the UK.

Finally, the name and address of the UK responsible person, where appropriate, must be included on the labelling of the product where the UKCA mark has been affixed. The details of the UK responsible person do not need to be included on the labelling of CE marked devices.

At Episkey Medical Consulting, we assist medical device manufacturers with market entry into the UK market.