A Manufacturer who is willing to place a device on the Great Britain market and its Authorized Representative must maintain technical documentation that demonstrates the conformity of the product with the regulatory requirements. These must be kept for up to 10 years after the product is placed on the market.
The content of the Technical File for UKCA is similar to that of Technical documentation prepared for EU MDR/IVDR with only minor differences in certain aspects.
All the other contents of the Technical Documentation are the same for both the marking systems.
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. However, Class I medical devices that are sterile or have a measuring function require approval from a UK Approved Body.
The UK DOC should be available to market surveillance authorities on request.
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