UKCA Marking

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UKCA Marking

UKCA Marking Medical Devices

The MHRA will appoint UK Approved Bodies to conduct conformity assessments of medical devices for the UKCA Marking beginning January 1, 2021. UK-based Notified Bodies that are currently designated under EU MDD, EU IVDD, or EU AIMDD will be automatically approved for UKCA marking assessments.

To be designated for carrying out UKCA conformity assessments, the new bodies must go through a thorough approval process. The UK Government is creating a new database that will include a list of UK Approved Bodies and will serve in a similar to New Approach Notified and Designated Organizations. The Technical Documentation requirements are almost similar to that of CE Marking. Readers are advised to read the CE Marking section to get additional information.

United Kingdom Conformity Assessment

UKCA Certification timeline depends on the intended use and risk class of medical devices. Manufactures and Exporters should be prepared to affix UKCA marking by January 1, 2023, at the very latest, however they should do so as soon as feasible.

The key point is that the Medicines and Healthcare Products Regulatory Agency (MHRA), which is already in place under the UK government, will take over responsibilities that are currently handled by the European Union. We will soon see products bearing the new United Kingdom Conformity Assessment (UKCA Mark) in place of, or in addition to, the well-known CE Mark.

Until 30 June 2023, companies will need a UKCA mark in order to sell devices in Great Britain, while CE marking continues to be used and recognized. The registration period comprises:

Class III and Class IIb implantable devices have a four-month time limit, and all active implantable medical devices have a six-month time limit.
Other Class IIb and all Class IIa devices have an eight-month time period.
Class I devices have a 12-month extended period. (Manufacturers of Class I devices and general IVDs, who are currently required to register with the MHRA, will be exempt from this grace period.)

UKCA Mark Consultants

The responsibilities of the UKCA Marking Consultants are the following.

Identify the device UKCA Requirements
Identify the device classification
Identify the route of UKCA marking
Identify the applicable standards
Review the Risk Management activities and Guidance on risk-benefit analysis
Clinical Evaluation and related Documentation (CER)
Post Market Surveillance (PMS)
QMS Implementation support
Review of Validation and Verification documents
Review of Sterilization documents if applicable
Software classification if applicable
Technical File Preparation, Review and Submission to UK CA Bodies
Review Primary and Secondary Label/Information panel
Review IFU/User Manual
Coordination and updating of Technical file

List of UKCA Approved Bodies

UKCA Marking Certificate will be issued by the UK approved bodies listed under Medical Devices Regulations 2002 (UK MDR 2002) detailed under new amended SI 2002 No 618.

Non-UK Manufacturers wishing to certify are requested to write to us for more details

Fees and Timeline

UKCA Marking timeline depends on the intended use and risk class of medical devices. The fee structure is almost similar to CE Marking. Refer CE Marking Approval Page

Manufactures and Exporters should be prepared to affix UKCA marking by January 1, 2023, at the very latest, however they should do so as soon as feasible.

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