UKCA FOR MEDICAL DEVICES

On 31 December 2020, the transition period following the United Kingdom’s (UK) exit from the European Union (EU) came to an end. UKCA (UK Conformity Assessed) marking has now come into force for products being placed on the market in Great Britain.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices and IVDs are regulated in the UK.

Government guidance

The legislation that applies in the UK is the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). The UK MDR 2002 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)

UKCA marking requirements for medical devices and IVDs are based on the requirements of the relevant Annexes to the EU Directives listed above and which have been modified by Schedule 2A to the UK MDR 2002.

MHRA ANNOUNCES 12-MONTH EXTENSION TO STAND-STILL PERIOD

The MHRA has announced a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024.

Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023.

From July 2024, the transitional arrangements as set out in the government response to the Consultation on the future regulation of medical devices in the United Kingdom will apply for CE and UKCA marked devices placed on the Great Britain market.

The government plans to introduce legislation by Spring 2023 that will bring into force these transitional arrangements and post-market surveillance requirements as outlined in the government response. 

Consultation on the future regulation of medical devices in the United Kingdom

The MHRA have acknowledged concerns raised relating to Approved Body capacity. The extension of the standstill period is expected to provide more time to progress the designation applications of Approved Bodies.

HOW DOES THE UKCA PROCESS AFFECT YOU?

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

Product registration:

• All medical devices and IVDs to be placed on the market in the Great Britain (England, Wales and Scotland) must be registered with the MHRA. Where applicable, details about conformity assessment by a UK Approved Body for UKCA, or an EU Notified Body for CE, must be provided during device registration. Note that registration requirements differ for Northern Ireland.
• 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

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.

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 June 2024, 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 June 2024. From July 2024, transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.
• In NI – CE marked devices can be placed on the market, even after June 2024

WHY CHOOSE TÜV SÜD FOR UKCA MARKING

For over 30 years, TÜV SÜD has provided certification services for manufacturers and suppliers of medical devices and in vitro diagnostics.

We have in-depth knowledge of the medical devices and IVD market and our dedicated team of experts, engineers, and medical doctors provide assessments that cover the full life cycle of your products. 

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

Please note, this information is based on current information and guidance. As the planned amendments to the UK Medical Devices Regulations are published and implemented there may be further changes to our current understanding. TÜV SÜD will continue to keep you informed on any changes and how it may affect you.