Which devices need UKCA Marking today (September 2026)?

The only medical devices that currently require UKCA Marking are those that 1) are not already CE Marked, and 2) where the manufacturer wishes to market the device in Great Britain* (England, Scotland, Wales).

If your device is CE Marked, then you can leverage it to market your device throughout the UK. Note that this does not mean you can freely sell with no further obligations. The MHRA does stipulate some additional requirements, such as:

*The UK is comprised of two distinct regulatory territories:

Do I need a UK Approved Body?

A UK Approved Body is the equivalent of a European Notified Body, and, currently, all the UK Approved Bodies also provide EU Notified Body services.

Like an EU Notified Body, a UK Approved Body is only required if you 1) plan to UKCA Mark your device, instead of (or in addition to) CE Marking, and 2) the risk classification of your device requires UK Approved Body intervention.

The following devices are “self-certified” and do not require UK Approved Body certification under the UKCA Marking system:

All other devices require UK Approved Body certification in order to be UKCA Marked.

What device conformity assessment options are available today?

Today manufacturers planning to market their device in Great Britain can UKCA and/or CE Mark their device. Either one is accepted.

If a company opts to UKCA Mark only, then they will be limited to the Great Britain market only (England, Scotland, Wales). If they opt to CE Mark, then they can market in both Great Britain and the European single market (EU-27 member states, Iceland, Liechtenstein, Norway, Northern Ireland, and Turkey).

See below why some companies may choose to UKCA Mark before, or in parallel, with CE Marking.

Do I need to register my device with the MHRA if it is CE Marked?

Yes, all medical devices (including custom-made), IVDs, and system/procedure packs must be registered in order to market in Great Britain. This is irrespective of if the device is UKCA Marked or CE Marked.

Currently, registrations can only be submitted by:

The MHRA charges an annual registration fee to maintain registrations. The first year is prorated based on the registration date, and going forward, the annual fee will be invoiced as of April 1^st of each year.

Will CE Marking be recognized indefinitely?

The MHRA recently opened a consultation regarding whether it would continue to recognize CE Marking, or if it would require an additional abridged review conducted by a UK Approved Body.

The consultation closed April 2026, and as of this writing, the MHRA has not published their decision on this topic. Therefore, while there is a strong possibility that CE Marking will continue to be recognized in Great Britain, it is not yet certain.

Will voluntarily UKCA Marking now help me later?

There are some devices for which UKCA Marking might have an advantage.

The UK Medical Device Regulation (MDR) 2002 (as amended) is currently based on the old EU Medical Devices Directive 93/42/EEC and EU IVD Directive 79/89/EC. This means that some products are eligible for self-certification under this legislation, that now require Notified Body CE Marking under the EU MDR and EU IVDR.

Examples include some software devices, some substance-based wound care products, Class I reusable surgical instruments, most in vitro diagnostic devices.

Due to the classification difference between the UK MDR 2002 and the EU MDR/IVDR, some companies opt to first enter Great Britain as a self-certified device while simultaneously going through the EU Notified Body certification process, which can take 1+ year to complete.

The MHRA is in the process of amending its legislation, including classification criteria. Therefore, companies have a limited time period to utilize this option. If companies UKCA Mark to the current UK MDR 2002, then they will have a transition period to comply with the revised classification rules, allowing them time to continue marketing with a Class I self-certified UKCA Marked device.

More information on this topic is available here: Is there any benefit to UKCA Marking early?

Can I register in the UK if I only have US FDA authorization?

At this time, only UKCA Marking and CE Marking are recognized in Great Britain. Devices cannot be marketed purely on the basis of FDA clearance/approval.

However, the MHRA is in the process of implementing legislation that will allow FDA devices a path to market. This is part of the MHRA’s new International Reliance framework.

Once in effect, it will allow companies to leverage their FDA clearance/approvals for an abridged review in Great Britain. The regulation will allow abridged reviews not only for US FDA devices, but also for devices with marketing approval through the Australian TGA and Health Canada.

Some restrictions will apply. More information about the draft framework can be found here.

Please see below for more information on expected timing of the new International Reliance framework.

When will the new UK legislation come into force?

The draft legislation, mentioned throughout the article above, will implement changes such as:

The draft legislation was published in May 2026, and the open consultation period closed in June 2026. At this time, industry is waiting for the MHRA to finish reviewing comments received during the consultation period, and propose a final version of the legislation to Parliament.

It will be laid in Parliament as a Statutory Instrument, which allows faster processing. Once approved by Parliament, it will be formally published and then should come into force six (6) months later. That said, the regulation may include further transition periods for certain requirements.