UKCA FAQ
Q: What is the UKCA?
A: The UKCA (UK Conformity Assessed) marking is a new product marking introduced by the United Kingdom (UK) for certain goods being placed on the market in Great Britain (England, Scotland, and Wales) after the UK’s departure from the European Union (EU).
Q: Who is the UKCA applicable to?
A: It is applicable to medical device and IVD (In Vitro Diagnostic) manufacturers outside the UK to comply with new market entry rules for selling their products in Great Britain.
Q: When can the CE mark be used in Great Britain until?
A: The CE mark will continue to be recognised for the majority of goods in Great Britain until December 31, 2024. This allows manufacturers with existing CE marks under MDD, MDR, IVDD, or IVDR to use their current CE marks for market entry during this transitional period.
Q: Where does the UKCA cover?
A: The UKCA mark only covers Great Britain, which includes England, Scotland, and Wales. Northern Ireland is exempt from the UKCA mark and continues to follow EU CE criteria (EU MDR and IVDR deadlines).
Q: Can manufacturers still sell medical devices in Great Britain post-Brexit?
A: To sell medical devices in Great Britain after Brexit, manufacturers must either have a current, valid CE mark in the EU (under MDD/MDR or IVDD/IVDR) or compile a Technical File (TF) outlining how they meet the Essential Requirements for the EU MDD/IVDD. Additionally, they must meet the device registration deadline with the UK MHRA (Medicines and Healthcare products Regulatory Agency).
Q: Can manufacturers outside the UK still sell in Great Britain?
A: Manufacturers outside the UK must identify and appoint a UK Responsible Person (UKRP) who will be responsible for carrying out device registration with the UK MHRA well before the devices’ registration deadline.
Q: What is the deadline to meet UKCA requirements?
A: Manufacturers must prepare to meet UKCA requirements by December 31, 2024, after the transitional period for recognizing the CE mark in Great Britain ends.
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