UK Market Access – Medical UKCA Certification

Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA).

Intertek Medical Notified Body UK Ltd has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the MHRA.

With its designation, Intertek is permitted to conduct UKCA conformity assessments and issue UKCA certificates for a range of active non-implantable and non-active medical devices, supporting clients to bring their products to market in Great Britain, as the UKCA marking will replace CE marking.

IMNB UK Ltd is one of the first organisations to become a UK Approved Body to certify medical devices since Brexit. For more information on the designated scope / types of medical devices for which the IMNB UK Ltd (AB number 8532) is permitted to issue UKCA certification, refer to gov.uk.

Dr Sharmila Gardner, Head of the UK Approved Body said: “This designation reflects the exceptional dedication of our staff, their expertise, and the maturity of our quality management system. We are delighted to be able to offer our existing and new medical device clients around the world a portfolio of services that now assures continued market access to the UK through UKCA and UKAS ISO 13485 certification.”

Being a global organisation, our medical device group will continue to serve our clients around the world.

Should you have questions regarding our activities as an Approved Body or wish to apply for UKCA certification , please contact your local office or e-mail us at imnb@intertek.com.

Medical United Kingdom Conformity Assessment Certification

Since 1 January 2021 there have been several changes to how medical devices are placed on the market in Great Britain (England, Scotland & Wales). A new route to market was introduced for manufacturers wishing to place a medical device on the market in Great Britain via the UKCA-marking.

In order to use UKCA marking on medical devices, manufacturers must ensure conformity to the UK Medical Device Regulation 2002 (as amended). The new conformity route is currently based on the foundation of the 90/385/EEC on Active Implantable Medical Devices and 93/42/EEC on Medical Devices and 98/79/EC on vitro diagnostic medical device directive which has been transposed into UK law and their conversion through implementation of Statutory Instruments. Please note that MDR will not apply in Great Britain. The UK MDR 2002 is undergoing changes to further diverge from the EU directives above and EU Medical Device Regulations.

Different rules apply for conformity assessments and marking of devices in the Northern Ireland market from those applying to Great Britain (England, Scotland, & Wales). Manufacturers wishing to place devices on the market in Northern Ireland should either have CE marking under an EU Notified Body or UKNI-marking. Further information is available through the MHRA’s website.

If you are a manufacturer based outside the UK and wish to place a device on the UK market, you need to establish a UK Responsible Person who takes responsibility for the product in the UK, and you must register all products on the MHRA website. Please visit MHRAs website for more information.

New Regulatory framework for medical devices in the UK.

The government's response to the consultation on the future regulation of medical devices in the United Kingdom was published on 26 June 2022. This describes the government’s response to the consultation and the MHRA’s next steps for the implementation of a transformed regulatory framework for medical devices in the UK.

The new regulation will come into force in 2025 and there are significant measures enabling products which have CE or UKCA mark to remain into force for a period of 3 to 5 years. The Government's response to the consultation will provide a direction of how the future UK regulatory framework for medical devices. The new measures will ensure innovations such as these are subjected to the same standards as medical devices.

The MHRA will gradually phase in the new requirements, yet to be published and enforced, to give industry enough time to adapt to the changes based on the transitional arrangements which includes:

• General medical devices and in-vitro medical diagnostic devices (IVDs) that are CE marked under EU MDR or EU IVDR may continue to be placed on the GB market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner, with a view to reviewing this provision at the end of the five-year period. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect.
• General medical devices and IVDs that are CE marked under EU MDD, EU AIMDD, or EU IVDD may continue to be placed on the GB market until either the certificate expires, or for three years (general medical devices) or five years (for IVDs) after the new regulations take effect, whichever is sooner.

As well, in both the cases above of CE-marked devices covered by these arrangements:

• Devices that are subject to significant changes in design or intended purpose will be excluded from these provisions
• All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements
• These post-market surveillance requirements are expected to apply from mid-2024.

For UKCA marked devices under the current UK regulation the transition period is three years for general medical devices and 5 years for IVDs, or when the certificate expire.

For more details please visit gov.uk.