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:
- 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)
UKCA mark requirements for medical devices in UK MDR 2002:
- General medical devices: Part II of the UK MDR 2002
- Active implantable medical devices: Part III of the UK MDR 2002
- In vitro diagnostic medical devices (IVDs): Part IV of the 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:
- BSI 0086: MDD, AIMD, IVDD
- SGS 0120: MDD, IVDD
- UL 0843: IVDD
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:
If you reduce or enlarge the size of your marking, the letters forming the UKCA marking must be in proportion to the version set out below.
- UKCA marking is at least 5mm in height – unless a different minimum dimension is specified in the relevant legislation.
- UKCA marking is easily visible, and legible (from 1 January 2023 it must be permanently attached)
What We Offer
- Act as your UK-Responsible Person
- Assist with UKCA marking of your devices
- Assist you with UK Registration in MHRA of your establishment and Products
- Technical File assistance
- Labelling requirements
- Notarisation & Legalisation
- Free sale certificate for UK
- Vigilance Reporting/Monitoring
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory Affairs solutions
Contact us for free consultation: [email protected]