UKCA Marking: Everything you need to know (2023)

UK Conformity Assessed (UKCA) Marking is similar in concept to European CE Marking. In fact, the current UK Medical Devices Regulation 2002 (SI 2002 No 618, as amended) (UK MDR 2002) is based on the European Union’s old Directives: MDD/AIMDD/IVDD. This is because the UK withdrew from the EU before the MDR/IVDR went into effect.

Therefore, an MDD/AIMDD/IVDD compliant technical file aligns with the UKCA technical file requirements. However, there are some gaps that must be addressed. Examples of gaps include:

- UKCA Marking certificate must be issued by a UK Approved Body, instead of a European Notified Body
  - Not applicable for class I self-certified medical devices and general, self-certified IVDs, which will self-affix UKCA Marking
- UKCA symbol must be used instead of the CE symbol
- UK Responsible Person (UKRP) is required instead of an EU Authorized Representative (EC Rep)
- Applicable legislation referenced through the technical file should be the UK MDR 2002
- UK Declaration of Conformity must be signed by manufacturer

NOTE: The UK MDR 2002 will soon be replaced with more robust legislation. It will be similar to the EU MDR/IVDR in many, but not all, respects. An overview of the proposed changes is available: HERE

Is my device classification the same under UKCA Marking and CE Marking?

The UK MDR 2002 is based on the EU’s old Directives; therefore, UK classifications currently align to those under the MDD/AIMDD/IVDD.

Once the UK’s legislation is amended, classifications are expected to align more closely to the EU MDR/IVDR.

Is UKCA Marking currently required in order to sell my devices in the UK?

No, UKCA Marking is not currently required. The MHRA allows devices to be marked in the UK leveraging UKCA Marking or CE Marking.

For medical devices and IVDs, the CE Marking cut-off period was initially 30 June 2023. However, the MHRA announced they intend to postpone UKCA Marking compliance until July 2024. As well, the MHRA will offer a longer transitional period for CE Marked devices. That official announcement is available: HERE

This means that the following transition periods apply:

MDR, IVDR, and IVDD CE Marked devices – five (5) year transition period after the new regulation takes effect, i.e., through July 2029

MDD and AIMDD CE Marked devices – three (3) year transition period after the new regulation takes effect, i.e., through July 2027

Devices UKCA Marked under the current regulatory framework will have the following transitional period:

UKCA Marked medical devices – three (3) year transition period after the new regulation takes effect, i.e., through July 2027

UKCA Marked IVDs – five (5) year transition period after the new regulation takes effect, i.e., through July 2029

The caveats outlined for both CE Marked and UKCA Marked devices are as follows:

“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”

Note that this does not exempt manufacturers from registering their devices with the MHRA, nor does it exempt foreign manufacturers from appointing a UK Responsible Person (UKRP). Whether the device is CE Marked or UKCA Marked, it must be registered before it can be placed onto the UK market. Where applicable, the designated UKRP will complete the registration on the manufacturer’s behalf.

For more information, please read: UK Medical Device Registration, UK Responsible Person

Can the same Notified Body that CE Marked my device also issue my UKCA Marking certificate?

The company that UKCA Marks your device must be an accredited UK Approved Body. The Approved Body must be a legal entity established in the UK and be designated by the MHRA.

Many Notified Bodies also offer, or intend to offer, UKCA marking certification. The MHRA publishes the full list of UK Approved Bodies: HERE

NOTE: Class I non-sterile/non-measuring devices and general IVDs do not require UKCA Marking through an Approved Body. Those devices are self-certified by the manufacturer.

Are European and/or international standards accepted for UKCA Marking?

Currently, yes. The UK’s list of designated standards can be found: HERE

As you will note in the link, the list of designated standards heavily references EU harmonized standards.

This will change as the new UK Medical Device Regulation is implemented, currently expected in July 2024. The new UK Regulation will be similar to the EU MDR/IVDR; however, it will deviate in certain areas. Therefore, there may be instances where the MHRA opts to still reference International/EU standards and instances where they may not.

What are the product labeling requirements under UKCA Marking? Are they very different from EU CE Marking requirements?

The medical device and IVD labeling requirements are the same as under the European Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and IVD Directive (IVDD).

While the requirements are the same, some of the information and terminology will be different. For example:

- UKCA symbol, instead of CE symbol
- UK Responsible Person (UKRP) information, instead of European Authorized Representative (EC Rep) information
- UK Approved Body four-digit identification number adjacent to the UKCA symbol, instead of the EU Notified Body four-digit identification number adjacent to the CE symbol

Otherwise, the information on your EU labeling can generally be used ‘as is’. This includes the recognized symbols under EN ISO 15223-1:2016.

Note that the national language in Great Britain is English. Non-proper nouns should therefore be in English, e.g., ‘do not reuse’ should be in written in English if the EN ISO 15223-1:2016 symbol is not used.

Can my device labeling have both the UKCA and CE Marking symbols on them?

Yes, it is acceptable to place both the UKCA and CE Marking symbols on the label. Where a device is both UKCA and CE Marked, other applicable information must also be applied to the label, such as: UK Approved Body four-digit identification number and the UK Responsible Person’s information.

If all labeling requirements are met and the information is clearly presented so as to prevent confusion for the user, then both sets of information (UK and EU) may be on the device labeling.

The MHRA’s guidance Regulating Medical Devices in the UK states:

“If you already have a valid CE marking on your device, you are not required to re-label the device with a UKCA marking until 1 July 2023 for placement on the Great Britain market. Devices can have both the CE and UKCA markings present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).”

NOTE: the MHRA has published their intent to postpone UKCA marking until July 2024, and to extend the CE Marking transition period for another 3-5 years after July 2024. However, the above guidance document has not yet been updated to reflect this longer transition period.

Where can I get the UKCA symbol?

The UKCA symbol is available on the MHRA’s webpage: HERE

Are there minimum size requirements for the UKCA symbol?

The UKCA symbol must be at least 5mm in height.

The full list of requirements from the MHRA’s UKCA Marking page is:

“You must make sure that:

- if you reduce or enlarge the size of your marking, the letters forming the UKCA marking must be in proportion to the version set out below
- the UKCA marking is at least 5mm in height unless a different minimum dimension is specified in the relevant legislation*
- the UKCA marking is easily visible, legible and indelible

The UKCA marking can take different forms (for example, the colour does not have to be solid), as long as it remains visible, legible and maintains the required proportions.”

*The medical device legislation specifies it must not be less than 5mm; however, that “this minimum dimension may be waived for small-scale devices”.

Where can I get the UK Responsible Person (UKRP) symbol?

The MHRA has not yet issued a UKRP symbol. Instead, the text “UK Responsible Person” should be written above the UKRP’s full name and address.

It is possible that the MHRA will never issue one, as there is only one national language to consider in Great Britain – English. The purpose of the EU Authorized Representative ‘EC Rep’ symbol is help minimize the volume of translations on labeling, due to the 20+ European national languages.

What needs to be on a UK Declaration of Conformity? Is it very different from an EU Declaration of Conformity?

The UK Declaration of Conformity requirements are the same as under the European Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and IVD Directive (IVDD).

While the requirements are the same, some of the information and terminology will be different. For example:

- Cite the UK legislation instead of the EU legislation
- UK Responsible Person (UKRP) information, instead of European Authorized Representative (EC Rep) information
- UK Approved Body Name and four-digit identification number adjacent to the UKCA symbol, instead of the EU Notified Body Name and four-digit identification number adjacent to the CE symbol

Casus has a more detailed overview of the UK Declaration of Conformity requirements, as well as free templates in word format, located: HERE

Does UKCA Marking expire?

Devices which require UKCA Marking Certification through a UK Approved Body:

These certificates will have an expiration date, after which manufacturers must apply for re-certification. Further, manufacturers are subject to surveillance audits in order to maintain the UKCA marking. This is the same process as with CE Marking certification through a Notified Body.

Self-certified devices:

Self-certified UKCA Marking does not ‘expire’ per se. That said, UKCA Marking, like CE Marking, is an active and ongoing process. The device technical file should not be hidden in a folder after completion. Manufacturers are expected to continually assess and update sections of the technical file, such as the clinical evaluation, risk management and post-market surveillance.

Do I need to update my MHRA device registration after I obtain UKCA Marking?

If you are already on the UK market leveraging your CE Marking, then yes, you will need to notify the MHRA of this change.

Currently, the MHRA does not allow manufacturers to modify their existing registration to exchange the CE information for the UKCA information. Instead, manufacturers must reregister the device. In the new registration application, they will select that the device conforms to UKCA marking and provide the UKCA marking certificate (mid-to-high risk) or Declaration of Conformity (self-certified).

Once the new registration has been granted, the other registration can be canceled.

NOTE: only UK manufacturers may complete their own registrations. All non-UK manufacturers must appoint a UK Responsible Person (UKRP) and the UKRP is responsible for completing all registration activities.

READ: UK Market Overview

READ: UK Responsible Person

UKCA Marking: Fact Sheet for Medical Devices & IVDs

UK MHRA Updates Vigilance Reporting Process

Official Announcement: UKCA Marking Postponed & CE Marking Transition Period Extended

What are the differences between UKCA Marking and CE Marking?