Medical devices carrying a CE mark under the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will continue to have access to the market in Great Britain without a time limit. The Medicines and Healthcare products Regulatory Agency (MHRA) announced the decision following a public consultation.
UK ends uncertainty over CE marking for medical devices
Medical device manufacturers will be spared duplicate certification processes to access the British market. The UK government has decided to recognise CE marking indefinitely, a move welcomed by industry.
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