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The UKCA mark stands for United Kingdom Conformity Assessment (UKCA). This is a brand new product accepted by the UK and applies to goods placed in the UK. This is a requirement for most CE-marked goods before Brexit. Medical devices require the UKCA mark and are also subject to some special regulations.
The UKCA mark is valid only in the United Kingdom and is not recognized in the EU. Equipment placed on the market in Northern Ireland must be CE or UK (NI) marked. Other markets that require the CE marking to place the device on the market, such as the EU and EEA, continue to need it. You can consider the best ukca certification at https://bluedicesolutions.co.uk/UKCA-mark/.
What are the compliance requirements for the UKCA mark?
Starting January 1, 2021, manufacturers of general class I and IVD medical devices can self-declaration in accordance with EU MD MD or EU IVDD; Paste the UKCA mark and start the device in the UK.
Once the UK Notification Agency has successfully obtained the UKCA Mark, the manufacturer and UKIP will ensure that the product technical documentation and the UK Declaration of Conformity are up-to-date and upon request Easily accessible by market supervisory authorities.
What are the rules for placing UKCA marks on devices?
If product sets are marked with UKCA, the following rules apply:
- Only the manufacturer or UKRP is authorized to put the UKCA mark on the device label
- The UKCA mark on the device label indicates that the device complies with applicable regulatory requirements and the manufacturer is responsible for compliance.
- The UKCA sign is affixed to indicate product compliance with relevant UK legislation
- Signs or other markings that misrepresent the meaning or form of the UKCA marking to third parties may not be included.
- All other markings that interfere with the visibility, legibility, or meaning of the UKCA marking must not be included on the label.