CE marking on toys, radios, and pyrotechnics will now be indefinitely recognised on the UK market, but medical devices or in vitro diagnostics will remain on their UK-based regulatory trajectory beyond 2030.
On Tuesday, the UK Government announced plans to indefinitely extend the use of CE marking for the majority of goods in what is being seen as the latest Brexit concession. However, the Medicines and Healthcare Regulatory Agency (MHRA) was quick to state that medical devices and in vitro diagnostics are already under amended legislation and will not be included in the extension plans.
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After Brexit meant medical device regulation in the UK moved away from European legislation, the government pivoted to make transition for the industry easier – giving extended timeframes in which CE-marked devices could be placed on the British market. In a statement, the MHRA was keen to remind companies of the deadlines which are unaffected by the blanket CE mark extension.
Makers of CE-marked medical devices that are compliant with the EU medical devices directive (EU MDD) or the EU active implantable medical devices directive (EU AIMDD) have until 30 June 2028 to place their products on the British market. For makers of in vitro diagnostic medical devices, the deadline is 30 June 2030. The latter deadline also applies to medical devices compliant with EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR).
Whilst outlining the implementation of the future regulatory framework for medtech, the MHRA stated it will also look to introduce post-market surveillance requirement (PMS) legislation in late 2023. The patient safety improving measures, which include requirements to collect data, report serious incidents, and conduct periodic reviews, are expected to come into force from mid-2024.
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By GlobalData
