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 Certification Process
The MHRA will appoint UK Approved Bodies to conduct conformity assessments of medical devices for the UKCA mark 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.
UKCA Mark Consultants
The roles end responsibilities of UKCA mark consultant is the same as of EU CE Marking consultants. More information refer the CE Marking pages.