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UK Med. Dev Guidance: UKCA Marking, MHRA Regulatory Advice, and the Future Medical Device & IVD Regime
Placing a medical device or in vitro diagnostic (IVD) on the UK market involves more than product design and manufacturing. Manufacturers must demonstrate regulatory compliance, engage effectively with regulators, and prepare for evolving post-market expectations. To support this, the UK government and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a series of guidances and roadmaps that explain both current requirements and the future direction
Sharan Murugan
Dec 20, 20253 min read
UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"
UK's Medicines and Healthcare Products Regulatory Agency (MHRA) this week (16,17 May 2023) released updated multiple guidances related...
Sharan Murugan
May 18, 20232 min read
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Notify the MHRA...
Sharan Murugan
May 13, 20232 min read
MHRA Guidance: Registration & Regulating Medical Devices in UK
Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...
Sharan Murugan
Apr 29, 20232 min read