UKCA Mark is a new UK product marking that will be used for medical devices placed in the Great Britain market after the transition period. The UK Conformity Assessed (UKCA) mark will be recognized only in England, Wales, Scotland. UKCA mark is not recognized in EU or Northern Ireland markets.
From 1 July 2023 the medical device a UKCA mark is necessary to place a device on the Great Britain market.
Depending on the classification, the medical device must undergo conformity assessment by the UK-approved body to demonstrate that the device fulfills the requirements stated in the different parts of the UK MDR 2002. The directives included in UK MDR 2002 are as follows:
UKCA mark requirements for medical devices in UK MDR 2002:
For Class I & general IVD:
Class I device or general IVD do not third-party conformity assessment. Class, I device manufacturers must self-declare that the device meets the UK MDR criteria. If a class I device has any sterile or measuring functions, the manufacturer needs to approach the UK-approved body for the conformity assessment.
For Class IIa, Class IIb, Class III, IVD:
For Class IIa, Class IIb, Class III, IVD medical devices involvement of a UK-approved body is necessary to undergo a conformity assessment procedure. After approval from a UK-approved body, a manufacturer can declare that devices conform with the UK MDR 2002 and place it on the market.
All class medical device manufacturers must sign a ‘declaration of conformity before placing the UKCA marking on their product. The manufacturer needs to include the name of the UK-approved body if it is involved.
Following are the UK Approved bodies by the MHRA. These UK Approved Bodies can conduct conformity assessments for UKCA marking:
Medical device manufacturer can apply for UKCA marking from 1st Jan 2021 to the UK approved body.
Rules for using the UKCA mark
You must make sure that:
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