October 28, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially delayed implementation of planned medical device regulations by 12 months in order to avoid potential supply disruptions and allow more time for preparing necessary systems and processes.
A new MHRA announcement states that the UK Medical Device Regulations 2002 (UK MDR 2002) currently sets a June 30, 2023 deadline for accepting medical devices with CE Marking, after which time transition plans whereby manufacturers will need to obtain UK Conformity Assessment (UKCA) certification as part of their UK compliance activities take effect.
The new announcement extends the deadline to July 2024 for launching the transition from CE Mark to UKCA certification of medical devices in Great Britain. The MHRA plans to update associated guidance on medical device regulations in the UK to reflect the extended implementation deadline.
Emergo by UL consultants in the UK and Europe will provide additional updates on UK medical device and in vitro diagnostic (IVD) regulatory changes as they become available.
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