However, Class I medical devices that are sterile or have a measuring function require approval from a UK Approved Body. These technical documentation need to be submitted to UK Approved body to demonstrate compliance to UKCA for all classes of device except Manufacturers of Class I medical devices and general IVDs who can self-declare their conformity against the EU MDD or EU IVDD as transposed by the UK MDR 2002 (as amended), before affixing a UKCA mark and placing the device on the Great Britain market. Therefore, the Technical Documentation and Declaration of Conformity for the UKCA mark would use the British national BS pre-fix, for example BS EN ISO 13857.Īll the other contents of the Technical Documentation are the same for both the marking systems. For the UKCA “UK Designated Standards” should be referred which are the British Standards.Proof of tests or compliance shall be provided in the form of test results for design safety standards. Third party declarations can either be UKCA or CE Declarations.
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