Page Last Updated: 9 January 2024

When is the UKCA Marking deadline for medical devices and IVDs?

For medical devices and IVDs, the CE Marking cut-off period was initially 30 June 2023. After this date, all medical devices were expected to have transitioned to UKCA Marking to remain on the market. However, in April 2023 the MHRA announced they intend:

This means that the following transition periods apply before CE Marked devices must be UKCA Marked:

Devices that are already UKCA Marked under the current (UK MDR 2002) regulatory framework will have the following transitional period to comply with the new (more robust) legislation:

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: 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.

Timeline

What are the main differences between UKCA & CE Marking?

UK Conformity Assessed (UKCA) Marking is similar 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:

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

Are UKCA and CE device classifications the same?

The UK MDR 2002 (SI 2002 No 618, as amended) is based on the EU’s old Directives; therefore, UK MHRA medical device classifications currently align to those under the MDD/AIMDD/IVDD.

That said, the MHRA does have some differences in criteria for what constitutes a medical device. Some borderline products (e.g., aesthetics, even with a medical claim) may have EU CE Marking to the MDD or MDR, but not be considered medical devices by the MHRA.

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

Is there an advantage to UKCA Marking Early?

It may help you to UKCA Mark early if you have a low risk device. Find out why.

Click Here

Can my Notified Body issue both my CE and UKCA Marking certificates?

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. Therefore, no, an EU Notified Body may not issue UKCA Marking. That said, many EU Notified Bodies also offer, or intend to offer, UKCA marking certification through a UK subsidiary/sister company.

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 EU 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 2025. 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.

Are UKCA labeling requirements the same as CE?

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:

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 the device labels have both the UKCA and CE information?

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:

“Devices can have both the CE and UKCA markings present on the labelling. 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).”

Where can I get the UKCA symbol?

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

What are the 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:

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”.

Is there a 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 is in a UK vs 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:

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 the MHRA registration after I UKCA Mark?

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.