UK Market Access – Medical UKCA Certification

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 under consultation during year 2022 and will undergo 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: www.gov.uk/guidance/regulating-medical-devices-in-the-uk

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: gov.uk/guidance/regulating-medical-devices-in-the-uk

Intertek Medical Notified Body UK Ltd (IMNB UK) has submitted its application to become a UK Approved Body.

For the past years, Intertek Medical Notified Body have worked intensively to expand our expertise and capacity to meet the increased demand from the market. Intertek Medical Notified Body is committed to continue its services to customers and has started the process to become a UK Approved Body in order to offer the UKCA certifications to clients.

UKCA Certification will be offered through our new legal entity based in UK, IMNB UK, once we have become designated as a UK Approved Body by the MHRA. Our client application process for the UKCA Medical device scheme will be published on the website upon designation. Our UK Approved Body ID will be assigned to IMNB UK Ltd once designated and listed in the UK Market Conformity Assessment Bodies (UKMCAB) database. We anticipate achieving our UK Approved Body designation during Q2 – 2023. IMNB UK Ltd will also be able to provide ISO 13485:2016 certifications once accredited by UKAS, we anticipate achieving the accreditation by UKAS during Q2- 2023.

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 a Notified Body, please contact your local office or e-mail us at imnb@intertek.com.

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.

As the document states, new regulation will come into force in 2023 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. This 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