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UKCA for Medical Devices

Latest guidance on marking following the transition period

On 31 December 2020, the transition period following the United Kingdom’s (UK) exit from the European Union (EU) came to an end. A new regulatory scheme, UKCA (UK Conformity Assessed) will be applied to products being placed on the market in the UK.

For medical devices, on 1 September 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance on how medical devices will be regulated in the UK from 1 January 2021.

Government guidance

The legislation that applies in the UK is the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). The UK MDR incorporates the requirements according to EU legislation on:

  • active implantable medical devices, Directive 90/385/EEC (AIMDD)
  • general medical devices, Directive 93/42/EEC (MDD)
  • in vitro diagnostic medical devices, Directive 98/79/EC (IVDD)

View Medical Device Regulations 2002

CE marked devices still accepted in the UK?

CE marked devices can still be placed on the market in the UK until 30 June 2023. However, manufacturers must:

  • Register their devices with MHRA (please refer to the diagram below for the deadlines for device registrations)
  • If located outside the UK, the manufacturer must appoint a UK Responsible Person
  • Manufacturers can continue to self-declare for Class I medical devices and general IVDs (and register with MHRA)

Becoming a UK Approved Body for Medical Devices

For continued and uninterrupted service to our customers, TÜV SÜD is in the application process with the MHRA to be designated as a UK Approved Body for medical devices. TÜV SÜD BABT is already a UK Approved Body for the following regulations below:

  • Marine Equipment Regulations 2016
  • Electromagnetic Compatibility Regulations 2016
  • Supply of Machinery (Safety) Regulations 2008
  • Radio Equipment Regulations 2017

Government guidance main points

The following timeline provides information on the key dates, including the requirements for registering products with the MHRA:

Other points to note:

  • UKCA mark will not be recognised in EU, EEA or Northern Ireland
  • For Northern Ireland, either the CE mark or dual UK(NI) CE mark will be required
  • Following approval from a UK Approved Body, a manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland)

How does this new UKCA process affect you?

The two key immediate points of impact for you as a manufacturer are:

  1. Product registration: the immediate impact to you is to ensure you register your products with the MHRA as soon as possible from 1 January 2021. As noted above, all devices to be placed on the market in the UK must be registered with the MHRA within the specified grace period (depending on the classification of your product). In order to register with the MHRA you must show evidence of having undergone conformity assessment by a UK Approved Body, or an EU Notified Body (in which case you should have CE certification). The CE mark will continue to be recognised; therefore, you can continue to place your products on the market in the UK until 30 June 2023.

    For further information on how to register your device with MHRA, please follow the links below:

    MHRA | Register as a manufacturer to sell medical devices

    MHRA | Device Online Registration System, DORS
  2. UK Responsible Person: If you are located outside of the UK, you will be required to appoint a UK Responsible Person (UKRP), located in the UK. The UKRP responsibilities will include registering your devices with the MHRA. UKRP should be appointed in line with the grace periods defined for device registrations.

Will you need to re-label all your products with the UKCA mark?

If your device is CE certified, you can continue place your product in the market in the UK until 30 June 2023, there will not be the need to re-label.

Please note that the requirements in Great Britain (England, Wales, Scotland) and Northern Ireland differ:

  • In GB – CE marked devices can be placed on the market until 30 June 2023. After this date UKCA requirements will be mandatory, and the UKCA-mark will be required
  • In NI – CE marked devices can be placed on the market, even after 30 June 2023

Why choose TÜV SÜD for UKCA marking

For over 30 years, TÜV SÜD has provided market access solutions and regulatory expertise for manufacturers and suppliers of medical devices and in vitro diagnostic devices. Our services put your product through its paces and ensure medical device market approval and acceptance.

TÜV SÜD (UK) is in the application process to become a UK Approved Body and once designated, together with our TÜV SÜD Product Service GmbH Notified Body, our dedicated team of experts will be able to offer both CE marking and UKCA marking services.

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