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 since been in force for products being placed on the market in the Great Britain.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices will be regulated in the UK: Government Guidance | Regulating medical devices in the UK

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.

TÜV SÜD BABT DESIGNATED AS AN APPROVED BODY FOR MEDICAL DEVICES

To ensure that UKCA and CE certification remains seamless for UK manufacturers, TÜV SÜD BABT has secured designation as a UK Approved Body (UKAB) for medical devices: TUV SUD BABT Designation Press Release

TÜV SÜD is a designated UKAB for Part II of the UK Medical Devices Regulations 2002 (SI 618, as amended) for General Medical Devices. Full details of the scope of designation can be accessed here: Medical devices: UK approved bodies

Contact us to submit your application today 

MHRA announces IMPLEMENTATION OF FUTURE MEDICAL DEVICES REGIME FROM 01 JULY 2025

The MHRA announced that they are aiming to introduce the core aspects of the future regime for medical devices from 01 July 2025.

Government Guidance | Implementation of medical devices future regime

Transitional arrangements

The UK Government has introduced legislation that amends the UK MDR 2002 and introduces transitional arrangements that extend the acceptance of CE marked medical devices onto the Great Britain market.

These transitional arrangements include the continued acceptance for CE marked medical devices in Great Britain based on the following timelines:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
• general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030

It is noted that self-declared CE marked Class I medical devices can only be placed on the GB market beyond 30 June 2023 in the following instances:

• when self-declared against EU MDR requirements (until 30 June 2030), or
• when self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.

Class I medical devices which are sterile or have a measuring function can be placed on the GB market based on a valid MDD certificate until 30 June 2028.

The MHRA have published an infographic to describe the transition periods for placing IVDs and medical devices on the GB market.

Further legislation is expected to be published later in 2023 that will, in advance of the wider future regulatory regime, implement strengthened post-market surveillance requirements as described in Chapter 8 of the government response to the consultation on the future regulation of medical devices in the United Kingdom.

impact of eu mdr transitional arrangement extending the validity of the eu mdd and eu aimdd ce certificates

The EU has revised the EU MDR transitional arrangements to extend the validity of EU MDD and EU AIMDD CE certificate in limited circumstances for certain medical devices. The MHRA have confirmed that such CE certificates can be relied on for placing a medical device on the Northern Ireland and Great Britain markets as described in the following MHRA guidance:

• MHRA | Register medical devices to place on the market
• MHRA | Guidance on registration of certain medical devices

As described in this guidance, during the medical device registration process manufacturers will need to complete and upload the EU MDR Article 120 extension confirmation template letter.

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 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 medical devices to place on the market
  • MHRA | Device Online Registration System, DORS
  • MHRA | Guidance on registration of certain medical devices
• 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.

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.

As a UK Approved Body, and together with our TÜV SÜD organisation, our dedicated team of experts can offer both CE marking and UKCA marking services.

By obtaining both UKCA and CE certification through TÜV SÜD at the same time, medical device manufacturers can minimise costs and time to market for new products across Europe.

Contact us to submit your application today 

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.