UKCA MARKING AND CERTIFICATION

The abbreviation UKCA stands for UK Conformity Assessed. UKCA marking is a new United Kingdom (UK) product mark that will be applied to items sold in the United Kingdom (England, Wales and Scotland).

The technical requirements (‘essential requirements’) must be satisfied as of January 1, 2021, and the conformity assessment methods and standards that can be used to establish compliance under UKCA marking are the same as those used for CE marking.

UNITED KINGDOM RESPONSIBLE PERSON (UKRP)

The UK Responsible Person (UKRP) is defined as a person based in any part of the United Kingdom who performs certain duties on behalf of a manufacturer based outside the United Kingdom in connection to the manufacturer’s obligations under these laws.

UK MHRA REGISTARTION

The Medicines and Healthcare Items Regulatory Agency (MHRA) in the United Kingdom has issued updated guidelines on medical device and IVD registration criteria and deadlines, which will take effect on January 1, 2021 for selected products.

Manufacturers must notify the MHRA before placing their device on the market in the United Kingdom, as required by the UK MDR 2002. If you or your organization sells, rents, lends, or gives presents, you must register.

CERTIFICATE OF FREE SALE (CFS)

Certificates of Free Sale (CFS) should not be construed as an endorsement by the government of any product mentioned on the certificate.

MHRA will issue a separate CFS according on the manufacturer, UK Responsible Person, or Authorized Representative’s location, and the mark of conformity.

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