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UK Medical Device Regulations: UKCA Marking and MHRA Clinical Investigation Requirements
The United Kingdom’s medical device regulatory system has changed significantly following Brexit. Medical device manufacturers that previously relied mainly on European Union regulations must now also understand UK-specific regulatory requirements for placing devices on the Great Britain market and conducting clinical investigations in the UK. To help manufacturers, sponsors, and regulatory professionals understand these expectations, the UK Medicines and Healthcare products
Sharan Murugan
May 174 min read
UK MHRA Guidance: Compliance with ICH E6 GCP in UK, Quality and Risk proportionality, & Clinical Investigations for Medical Devices
The UK clinical trial regulatory framework is undergoing a major transformation with the implementation of updated ICH E6 (R3) Good Clinical Practice (GCP) principles, alongside new guidance on quality, risk proportionality, and clinical investigations. The guidance Clinical trials for medicines: Compliance with ICH E6 Good Clinical Practice (GCP) in the United Kingdom, Clinical trials for medicines: guidance on quality and risk proportionality, and Clinical investigations fo
Sharan Murugan
Apr 253 min read
UK MHRA Guidance: Clinical Investigations for Medical Devices
As the UK strengthens its regulatory framework for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) outlines a clear system for sponsors intending to conduct clinical investigations. These investigations are essential for generating evidence on device performance and safety before market approval. The MHRA guidance, “ Clinical investigations for medical devices " : that provides a structured route that sponsors must follow before initiating any
Sharan Murugan
Dec 7, 20253 min read
UK MHRA Med. Dev Guidance: Clinical Investigations in the UK: When & How to Notify MHRA
Conducting clinical investigations for medical devices in the UK requires strict adherence to MHRA’s updated regulatory framework, designed to support patient safety, device innovation, and compliance with evolving UK (and EU for Northern Ireland) requirements. The guidance “ Notify MHRA about a clinical investigation for a medical device ” provides a clear roadmap for manufacturers, sponsors, and investigators who plan to conduct clinical investigations of medical devices i
Sharan Murugan
Nov 15, 20252 min read
India CDSCO Guidance: Subject Expert Committee (SEC), What Pharma and Clinical Trial Teams Need to Know
The Central Drugs Standard Control Organization (CDSCO) under India’s Ministry of Health & Family Welfare has released a detailed...
Sharan Murugan
Jul 23, 20252 min read
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...
Sharan Murugan
Nov 3, 20242 min read
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...
Sharan Murugan
Oct 2, 20242 min read
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...
Sharan Murugan
Mar 16, 20231 min read