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UK MHRA Med Dev Guidances: Legal Requirements for Specific Medical Products and the Health Institution Exemption
Medical device regulation in the UK is designed to ensure that products placed on the market or manufactured for patient use are safe, effective, and appropriately controlled. While most manufacturers are familiar with the general requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002), certain categories of devices and manufacturing scenarios are subject to additional, specific legal provisions. Two important MHRA guidance documents explain these areas in detai

Sharan Murugan
Dec 20, 20253 min read
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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
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