Regulatory Blog

The US Food and Drug Administration (FDA) has issued Regulatory Considerations for Prescription Drug Use-Related Software, a guidance for industry addressing the application of drug labeling requirements to software developed or distributed by, or on behalf of, prescription drug sponsors. The guidance explains how FDA considers software-generated content presented to patients, caregivers, and healthcare professionals, and how this content should be addressed in prescription d

The Medicines and Healthcare products Regulatory Agency (MHRA) guides registering medical devices for placement on the Great Britain and Northern Ireland markets. The guidance covers the registration process, placing devices on the market, putting devices into service, importers, in vitro diagnostic devices (IVDs), fees, registration updates, and specific transitional arrangements for devices with expired or expiring CE certificates. Registration for the Great Britain Market

The U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles for Good Machine Learning Practice (GMLP) in medical device development. These principles aim to support the development of safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). They address the unique challenges associated with data-driven de

The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template. These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and

Effective pharmacovigilance is essential for protecting patients and supporting the safe and effective use of medicinal products. The Guidelines on Good Pharmacovigilance Practices (GVP) provide a framework for pharmacovigilance activities in the European Union. The latest introductory cover note announces the publication of Revision 2 of Module III on Pharmacovigilance Inspections, reflecting recent changes to the applicable European pharmacovigilance legislation. Background

Accurate and structured medicinal product information is an important part of the regulatory and pharmacovigilance framework. Chapter 3.II: XEVPRM Detailed User Guidance provides detailed instructions for marketing authorisation holders (MAHs) on the electronic submission of information on medicinal products for human use to the European Medicines Agency through the XEVMPD. What is XEVPRM? XEVPRM stands for eXtended EudraVigilance Medicinal Product Report Message. It is the m

Dental restorative materials and curing devices are important components of modern dentistry, and their safety and performance must be demonstrated before marketing. The U.S. Food and Drug Administration (FDA) has issued guidance documents describing recommendations for premarket notification (510(k)) submissions for dental composite resin devices and dental curing lights. The two guidance documents provide device-specific recommendations covering device description, predicat

The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline for Borderline Products to help determine the appropriate regulatory pathway for products where classification is unclear. The guideline addresses products that may fall within categories such as medicines, medical devices, cosmetics, disinfectants, foodstuffs or other consumer products. Classification is determined on a case-by-case basis. What Are Borderline Products? Borderline product

Generative artificial intelligence (GenAI) is creating new opportunities for medical devices while also introducing regulatory challenges that may differ from traditional software and AI-enabled devices. The U.S. Food and Drug Administration (FDA) is seeking public input on how GenAI-enabled medical devices could be evaluated and monitored while maintaining reasonable assurance of safety and effectiveness. The FDA’s Center for Devices and Radiological Health (CDRH), through i

As medical device development becomes increasingly focused on clinical evidence, sponsors and manufacturers must understand when a clinical investigation requires regulatory notification and how to manage the study throughout its lifecycle. In the UK, clinical investigations may be required to generate evidence supporting UKCA, CE or CE UKNI marking, making regulatory planning an important part of device development. The Medicines and Healthcare products Regulatory Agency (MH

Clinical investigations of medical devices require a comprehensive submission that provides the MHRA with sufficient information to assess the safety and performance of the device. The MHRA guidance Clinical Investigations: Compiling a Submission explains how manufacturers should notify the MHRA of a planned clinical investigation and sets out the information and supporting documentation required for assessment. Why This Guidance Is Important The guidance provides manufacture

As medical devices become increasingly sophisticated, ensuring that they are safe and intuitive to use is just as important as demonstrating their technical performance. Many device-related incidents are not caused by product failure but by use errors that arise from complex interfaces, confusing instructions, or challenging use environments. The U.S. Food and Drug Administration (FDA) has updated the guidance Applying Human Factors and Usability Engineering to Medical Device

Hemodialysis blood tubing sets are critical components of the extracorporeal blood circuit used during hemodialysis treatment. Manufacturers submitting a Premarket Notification (510(k)) for these devices should provide sufficient information to demonstrate that the device is safe, effective, and substantially equivalent to a legally marketed predicate device. The Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions outlines recommendations for device d

Clinical investigations play an important role in generating clinical evidence to demonstrate the safety, performance, and clinical benefit of medical devices before they are placed on the market. Manufacturers and sponsors must determine when a clinical investigation is required and follow the appropriate notification procedures before commencing a study in Great Britain. The guidance documents Medical Devices That Need a Clinical Investigation and Clinical Investigations fo

Clinical investigations are an essential part of demonstrating the safety and performance of medical devices before they are placed on the market. Organizations conducting investigations in Great Britain must ensure that studies are appropriately planned, approved, and supported with complete regulatory documentation. The guidance documents Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission outline the regulatory framework,

Switzerland's regulatory framework for medicinal products and medical devices places strong emphasis on product quality, effective market oversight, and the safe conduct of clinical investigations. Recent Swissmedic information sheets provide important requirements for pharmaceutical companies, medical device manufacturers, sponsors, investigators, and other stakeholders operating in Switzerland. This blog provides a concise overview of three Swissmedic information sheets cov

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