UKCA CERTIFICATION OF MEDICAL DEVICES

The UK government introduced its own Conformity Assessed (UKCA) Marking programme for items to be sold in the GB (England, Scotland, and Wales) market on January 1, 2021.  Northern Ireland has its own set of rules, which are outlined here. There is no mutual recognition of marks between the UK and EU

What does the UKCA mark indicate?

The producer declares that a product fulfils the UK Regulations as stated in the applicable Statutory Instruments by affixing a UKCA mark to it and placing it on the UK market (SIs).

UKCA MARKING PROVISIONS AND APPROVED BODIES

The phrase “UKCA Mark” refers to any product conformity marking necessary to sell medical devices in the United Kingdom. Similarly, the term “Approved Body” encompasses additional appointment types such as Designated Body or Technical Assessment Body (TAB).

  • Unless specific arrangements, such as those for medical equipment, are in place, all items put on the UK market must be UKCA labelled as of January 1, 2023.

  • After December 31, 2021, qualified Northern Ireland goods can be put on the UK market with an EU conformity assessment marking, such as the CE marking.

  • CE Mark for medical devices will be recognised in the UK until June 30, 2023, providing that UK and EU laws stay unchanged.
  • Products that are currently CE certified based on an EU Notified Body assessment will be needed to be examined by the UK Approved Body for UK market access from January 1, 2023.

Conformity assessment by Notified bodies operating from the UK will no longer be recognised in the EU as of January 1, 2021, and certifications issued by such bodies will no longer be valid.   Existing notified Bodies in the United Kingdom will cease to exist and will be replaced by UK Approved Bodies with the same scope and they will carry out the same tasks but under UK MDR 2002.

UKCA MARK CONSULTANTS

The UKCA Compliance Consulting team from I3CGlobal have the sound knowledge, technical capability and large headcount to start any project in no time. We have end to end solutions for compliance needs.

  • Identify the legislation, standards and route of UKCA Marking

  • If enforcement action is taken against foreign manufacturer, EU Representative should cooperate with the authorities.

  • Perform any other responsibilities outlined in the written mandate that they and the manufacturer have agreed on.

  • Coordinate with Approved Bodies during technical file review and onsite audit

The following devices are exempted to use UKCA Mark

  • Custom-made device
  • Devices used exclusively for clinical investigation
  • An in-Vitro diagnostic device used for performance evaluation
  • Non-compliant devices used under humanitarian grounds

UKCA TECHNICAL DOCUMENTATION (TECHNICAL FILE)

Our extensive knowledge of European legislation will aid in a smooth and efficient registration process. We give all our authorized representation customers with recurring and detailed information on crucial European Market regulatory revisions. In addition to our German office, we have offices in India, Malaysia, UK and USA. Regardless of the time zone, we can provide expert assistance to you.

We guide manufactures on requirements and compliance formalities

Access the infrastructure and other resources for the suitability of the manufacturing and audit clereance

Cleanroom validation

Guidance on Validation

Identification of harmonized and non harmonized standards

Identify and guide on the requirments

Guidance on labelling

Guidance and review of Risk-benefit

Usability

PRICING (MDR 2002)

Fixed charges  I  Time-bound Service  I  Flexible timming

  • 24X7 Chat support

  • 6 days working and processing files

  • Economic pricing and polite staff

Fee per intended use / GMDN Code / Per Construction 5000 Euros

Fee per intended use / GMDN Code / Per Construction 14000 Euros

Fee per intended use / GMDN Code / Per Construction 17000 Euros

Fee per intended use / GMDN Code / Per Construction 20000 Euros

CONTACT US

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