Regulatory Blog

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

The UK’s post-Brexit regulatory landscape for medical devices continues to evolve, placing renewed emphasis on safety, performance, and transparency. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued clear guidance on both registering medical devices for market access and conducting clinical investigations, ensuring compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002) and the Windsor Framework. This combined overview summarizes the lat

Medical devices, whether diagnostic, therapeutic, or assistive, undergo rigorous scrutiny before entering the UK market. One of the most...