United Kingdom

UKCA Marking

The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland).
The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE marking for sale in these markets. The Northern Ireland market use their own UKNI mark.

Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the GB market until 30 June 2023.
From 1 July 2023, a UKCA marking will be required in order to place a new device on the Great Britain market.

UK Responsible Person

Manufacturers who are not based in the UK, will need to appoint a UK Responsible Person.
With our UK Responsible Person we will
• Verifying the documentation and the Technical File
• Register devices with MHRA
• Represent the manufacturer in UK
• Keep a copy of the Technical File for inspection by MHRA
• Work with MHRA for information upon request
• Inform the manufacturer of complaints and incidents

UKCA marking requirements are based on the requirements of the relevant Annexes to the Directives listed below, which have been modified by Schedule 2A to the UK MDR 2002:
• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

UK Approved Bodies

The MHRA can designate UK Approved Bodies to conduct conformity assessments against the relevant requirements for the purpose of the UKCA marking.
 
UK Notified Bodies that previously had designations under the EU MDD, EU IVDD or EU AIMDD have had their designations rolled over automatically, without having to undergo a new designation process.

For the purposes of the Great Britain market, UK Approved Bodies can conduct conformity assessments in relation to the UKCA marking, for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002. UK Approved Bodies are not able to conduct conformity assessments in relation to the CE marking.
 
The UK Market Conformity Assessment Bodies (UKMCAB) database serves as the UK’s database of conformity assessment bodies. It is the definitive source and a register of UK Government-appointed conformity assessment bodies who can certify goods for the Great Britain market.
 
The MHRA can designate UK Notified Bodies for the purposes of conducting conformity assessment for the combined CE and UKNI marking, which is valid on the Northern Ireland market.

Class I medical device

Manufacturers of non-sterile and non-measuring Class I medical devices and general IVDs can self-declare the conformity of their devices against the UK MDR 2002, before affixing a UKCA marking and placing the device on the Great Britain market.
 
Manufacturers of Class I medical devices that are sterile or have a measuring function must use a UK Approved Body to undertake third party conformity assessment in order to affix the UKCA marking and place their devices on the Great Britain market.

CE marking

MHRA will continue to accept CE marked devices on the Great Britain market until 30 June 2023. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation:
• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
  (for devices that have been CE marked prior to 26 May 2021)
• Directive 93/42/EEC on medical devices (EU MDD)
  (for devices that have been CE marked prior to 26 May 2021)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
  (for devices that have been CE marked prior to 26 May 2022)
• Regulation 2017/745 on medical devices (EU MDR)
• Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)

From 1 July 2023, devices that are placed on the Great Britain market will need to conform with UKCA marking requirements.

In cases where you self-certify for the CE marking, you will be able to continue to do so and place your device on the Great Britain market until 30 June 2023. Please note that you will need to meet EU MDR requirements for CE marking Class I devices that you self-certify from 26 May 2021. Similarly, you will need to meet IVDR requirements for CE marking if you self-certify general IVDs from 26 May 2022.

Relevant devices that have been self-certified against the CE marking prior to these dates may continue to be placed on the Great Britain market providing their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.

Where medical devices are subject to the requirements of any of the medical devices legislation cited above and, in order to be CE marked, must also meet the relevant requirements of another piece of EU legislation (such as the Directive restricting the use of certain hazardous substances), they can remain on the Great Britain market carrying a CE mark until 30 June 2023 – irrespective of whether the UK legislation governing the subject matter of that other piece of EU legislation would require a product to have a UKCA marking before 30 June 2023. In order to maintain the use of the CE marking for a medical device in Great Britain, the manufacturer will need to meet all relevant EU legislation that governs their device.

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