UKCA marking (UK Conformity Assessed marking) is the proposed UK product marking requirement that will be needed for products being placed on the UK market, substituting the EU requirements for CE Marking.
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The United Kingdom Conformity Assessment Mark or UKCA Mark for short is the UK equivalent of the EU CE marking. UKCA Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United Kingdom Conformity Assessment (UKCA) marking is mandatory for medical devices sold on the market in Great Britain (England, Wales, and Scotland).
United Kingdom’s Medicines and Health Care products Regulatory Agency (MHRA) On 18 September 2019, published new guidelines to regulate medical devices after Brexit. The UKCA will not be recognized in the EU, EEA, or Northern Ireland and products still require a CE marking for sale in these markets.
The manufacturer or their authorized representative will be responsible for affixing the UKCA mark to the product, which is the same principle as for CE marking but for the UK market.
The extent of Documented Information differs as per:
• Finding standard applicable to the product
• Selecting the appropriate certification scheme
• Based on the scope of the product and certification scheme
• Technical file, Plant Master file and Test Protocol
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
• UKCA Mark Awareness training to QC manager and Production Manager.
• Implementing a well-documented manual throughout the life cycle of the product
• Internal audits identifying nonconformities related to UKCA Mark requirements
• Management Review Meetings.
• Corrective and Preventive Action plan for nonconformities
• Shamkris acts on your behalf and assists you in the third-party audit.
• Closing of any nonconformities identified by the Self Certification/NoBo/MHRA
• UKCA Mark certificates issued for 5 years
• Surveillance Audits yearly
• Support of Yearly documentation for audit
UKCA marking (UK Conformity Assessed marking) is the proposed UK product marking requirement that will be needed for products being placed on the UK market, substituting the EU requirements for CE Marking.
The UKCA marking applies to most goods previously subject to the CE marking. … In some cases, you need to apply the new UKCA marking to goods being sold in Great Britain immediately from 1 January 2021. The CE marking is only valid in Great Britain for areas where GB and EU rules remain the same.