UKCA Marking Update: New Timelines and Strategies for Great Britain
HL Associates Team
Regulatory News Desk
The MHRA Standstill
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided significant relief to the medical device industry by extending the acceptance of CE marked devices on the Great Britain market. Depending on the legislation under which your CE mark was issued (MDD vs MDR), your device may remain on the UK market without a UKCA mark until 2028 or 2030.
Preparing for the Future
While the immediate pressure of the UKCA mark has diminished, manufacturers must still appoint a UK Responsible Person (UKRP) and register their devices with the MHRA to legally sell in Great Britain. Waiting until the final deadline to transition to UKCA will likely result in the same Notified Body capacity crunch seen in the EU.
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