Regulatory Blog

Innovation is transforming medicinal product development through the introduction of novel methodologies such as biomarkers, digital health technologies, artificial intelligence (AI), modelling and simulation, real-world data, patient registries, and advanced non-clinical testing methods. These approaches have the potential to improve evidence generation, streamline drug development, and support more informed regulatory decision-making. However, before they can be widely adop

Determining whether a product qualifies as a medical device is one of the most important regulatory decisions for manufacturers before placing a product on the Great Britain market. Many products fall into a "borderline" category because they may share characteristics with medicines, cosmetics, food supplements, biocides, personal protective equipment (PPE), or other regulated products. To provide greater regulatory clarity, the Medicines and Healthcare products Regulatory Ag

Manufacturers who intend to place medical devices on the market in Great Britain or Northern Ireland must comply with the registration requirements established by the Medicines and Healthcare products Regulatory Agency (MHRA). The Register Medical Devices to Place on the Market guidance explains which devices require registration, who is responsible for registration, applicable timelines, registration procedures, and the associated fees. It also outlines the differences in re

As clinical research continues to evolve, decentralized clinical trials (DCTs) are becoming increasingly important. By incorporating technologies such as telemedicine, remote monitoring, electronic consent, and home healthcare services, decentralized trials can reduce participant burden and improve access to research opportunities. Recognizing this shift, Health Canada launched a consultation on its Draft Guidance for Decentralized Clinical Trials (DCTs). Feedback from indust

Human factors engineering focuses on understanding how users interact with medical devices and applying that knowledge to design safer and more effective products. The FDA explains that user interface design can significantly impact patient safety, as user errors may lead to incorrect treatment, delayed therapy, compromised medical care, or patient harm. Manufacturers routinely perform human factors assessments during device development to identify and mitigate use-related ri

The International Medical Device Regulators Forum (IMDRF) continues to strengthen global harmonisation of medical device quality management systems (QMS) through updated guidance focused on supplier controls and risk-based oversight. A major development in this area is the draft guidance titled “Guidance on the Control of Products and Services Obtained from Suppliers ”, published by the IMDRF Quality Management Systems Working Group. The IMDRF draft guidance provides detailed

To support industry stakeholders, the UK Medicines and Healthcare products Regulatory Agency (MHRA) offers a dedicated Regulatory Advice Meeting service for medical devices and in vitro diagnostic devices (IVDs). This service helps organisations better understand regulatory expectations, clarify complex requirements, and navigate the UK regulatory system more effectively. The MHRA guidance titled “Medical devices: get regulatory advice from the MHRA” explains how manufacturer

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

Patient-matched medical devices are becoming increasingly important in modern orthopedic surgery. These devices are designed specifically for individual patients using imaging data such as CT scans or MRI scans. The goal is to help surgeons position orthopedic implants more accurately during surgery and improve overall surgical planning. To provide clearer regulatory expectations for manufacturers, the U.S. Food and Drug Administration (FDA) published the guidance titled “Pat

The European Union has taken another major step toward strengthening the efficiency, predictability, and consistency of medical device and in vitro diagnostic (IVD) certification processes. On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, which was subsequently published in the Official Journal of the European Union on 5 May 2026. The regulation establishes uniform quality management and procedural requirements for conformity as

The traditional clinical trial model has long been associated with delays in data reporting, lengthy timelines, and inefficiencies in decision-making. Recognizing these challenges, the U.S. Food and Drug Administration (FDA) has taken a transformative step toward modernizing clinical research. This press announcement was released on April 28, 2026, marking a significant milestone in the evolution of clinical trials. The FDA introduced major steps to advance the implementation

The European Union continues to strengthen its medical device regulatory framework through updated guidance on device classification, nomenclature (EMDN), and supply chain transparency. These updates aim to improve regulatory clarity, traceability, and patient safety, particularly under the MDR and IVDR frameworks. Key developments include the Update – MDCG 2021-24 Rev.1: Guidance on classification of medical devices (April 2026), alongside supporting guidance documents on EM

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

The FDA continues to strengthen regulatory expectations across both pharmaceutical quality and medical device oversight, with two important draft guidances issued in April 2026. The guidance Establishing Impurity Specifications for Antibiotics (April 2026, Draft) and Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators (April 20, 2026, Draft) provide structured recommendations for industry and regulators. Guidanc

The South African regulatory framework for medical devices is strengthening its oversight to ensure full accountability across the supply chain , particularly when activities are outsourced to third parties. The South African Health Products Regulatory Authority (SAHPRA) has clarified that outsourcing does not reduce regulatory responsibility and that all parties involved must comply with licensing requirements. The guidance Licensing Requirements for Outsourced or Contracted

The UK regulatory framework for medical devices continues to evolve with a strong focus on market transparency, safety, and clinical evidence generation . Recent updates from the Medicines and Healthcare products Regulatory Agency (MHRA) reinforce the importance of proper device registration and clinical investigation oversight to ensure patient safety and regulatory compliance. The guidance Register medical devices to place on the market was updated on 10 April 2026 , in

The guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle was issued on 30 March 2026 , updating and superseding the earlier 2016 guidance, and providing comprehensive recommendations on how patient preferences can inform benefit-risk assessments. The FDA recognizes that patients living with diseases or conditions develop first-hand insights into treatment benefits and risks. Their perspectives can play a critical role in evaluatin

The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices was published on 31 March 2026 , outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice. Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evi

Introduction The Therapeutic Goods Administration (TGA) released multiple New & updated guidance s on 16 March 2026 , that provides clarity on when certain software products may be excluded from medical device regulatory requirements . With the rapid growth of digital health technologies, this guidance helps distinguish between software that requires regulation and software that can be safely excluded based on its intended use and risk profile. Background As digital health s

Medical devices intended for weight management play an important role in addressing obesity and related health conditions. The U.S. Food and Drug Administration (FDA) has issued guidance to help manufacturers understand regulatory expectations when developing and submitting premarket applications for medical devices with indications associated with weight loss. The FDA guidance titled “ Medical Devices with Indications Associated with Weight Loss: Premarket Considerations ”