The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, placed on the Great Britain market (England, Wales and Scotland) since 1 January 2021. The UKCA mark is not recognised in the EU, EEA or Northern Ireland and does not substitute for CE marking, so relevant products continue to require CE marking for sale in these markets.
QFI is increasingly aware of manufacturers failing to fulfil their obligations under recent changes to UK medical device legislation. Manufacturers relying on CE marking conformity assessment, including technical documentation, are advised to rectify any deficiencies or incoherence urgently and to implement the requisite documented processes and procedures.
QFI is adept at improving technical documents and documented controls to assist manufacturers in this.
QFI’s UKCA mark service assesses the preparedness of manufacturers’, distributors’ and other UK economic operators’ systems, conformity, and evidence against applicable regulations, including all UK Statutory Instruments and other legislative acts. We formulate effective implementing programmes, and produce bespoke, compliant processes and procedures to effect compliance in your company.
Where instructed, QFI integrates and implements comprehensive, documented systems solutions within your QMS or other management system, as part of a process (based) approach consistent with conventional risk-thinking approaches.