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UK Med Dev Guidance: Comprehensive Guide to Registering Medical Devices in Great Britain and Northern Ireland
With the regulatory landscape evolving in the UK post-Brexit, manufacturers, importers, distributors and authorised representatives must be fully aligned with the registration requirements laid out by the MHRA. The guidance titled “ Register medical devices to place on the market ” sets out the detailed steps, legal framework, responsibilities and timelines you must meet for compliant market entry. Under the guidance, every medical device (including in-vitro diagnostics (IV
Sharan Murugan
22 hours ago2 min read
UK MHRA Guidance: Modifying Clinical Trial Approvals in the UK
With the 2025 amendments to the Medicines for Human Use (Clinical Trials) Regulations taking effect on 28 April 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive guidance “ Clinical trials for medicines: modifying a clinical trial approval” for sponsors and investigators which outlines how to manage changes to an approved clinical trial of a medicinal product. Types of Modification Modifications to a clinical trial approval f
Sharan Murugan
22 hours ago3 min read