UKCA Vs CE: How New Regulations Affected The Manufacturing Of Medical Devices

UKCA Vs CE: How New Regulations Affected The Manufacturing Of Medical Devices

CE Marking

CE marking is a type of self-declaration in which an organization or manufacturer declares their conformity with the Medical Device rules and regulations in the European Union. It states that the medical device complies with the rules and regulations of the EU and is safe to use. In the same way, UKCA proves that UKCA-certified devices comply with the UK’s new MDR regulations followed for medical device registration and are safe to use.

UKCA Marking

There will be a transition period to 30 June 2023 to allow existing CE certifications to be replaced by the new UKCA mark. From 1 January 2021, medical devices must be registered with the MHRA before being placed on the UK market irrespective of whether UKCA is marked or CE marked.

The process that Manufactures Must Follow:

Identify the directive(s)
Check the product-specific requirements
Identify whether an independent conformity assessment is required from a Notified Body
Test the product and check its conformity
Draw up and keep the necessary technical documentation – which includes examination certificates, how the product is manufactured, design and manufacture of products, etc.
Placing the CE Marking on your product and EC Declaration of Conformity