UKCA Marking guidance

This is a quality assurance test performed by an independent body to ensure that a medical device
complies with relevant European Union regulations

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UKCA Marking Guidance

This is a quality assurance test performed by an independent body to ensure that a medical device complies with relevant European Union regulations. A notified body is a company or organization which has been designated by the European Commission to perform such tests. The purpose of the test is to verify whether the product meets the requirements set out in the legislation.

Importance of UKCA:

– The United Kingdom Conformity Assessment (UKCA Marking) is the UK equivalent to the EU CE Marking.

– The UKCA Marking is a valid indicator that the product conforms to relevant UK regulations.

– The UKCA is a mandatory requirement for medical devices sold in the UK post Brexit.

– Manufacturers or their authorised representatives are responsible for affixing this mark to the product.

– The UKCA mark can only be used on products manufactured in the UK.