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UK MEDICAL DEVICE REGULATOR PROPOSES A 12 MONTH DELAY FOR UKCA REQUIREMENTS AND THE NEW MEDICAL DEVICE REGULATIONS

Regulatory NewsBy Admin October 28, 2022

On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: To extend the current standstill period by twelve months from July 2023 to July 2024.

UKCA Marking Delay: One Year Extension to the Acceptance of CE Marking in UK

Regulatory NewsBy Admin September 9, 2021

The UK Government has announced an extension to the acceptance of CE marking in the UK until 1 January 2023. This means the businesses will have a further year to start using the UKCA marking for products placed on the Great Britain market, extending the deadline to 1 January 2023.

UK Regulator releases more device registration particulars

Regulatory NewsBy Admin July 19, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance giving details impor¬tant for companies registering devices on the UK market.