Regulatory Blog

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

Understanding MHRA Guidance on Medical Device Regulations, Regulatory Advice Meetings, and Regulatory Support Medical device manufacturers must navigate a wide range of regulatory requirements throughout the product lifecycle, from development and market access to post-market compliance and safety monitoring. To support stakeholders, the Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidance documents covering medical device regulatory requi

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not

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 South African Health Products Regulatory Authority (SAHPRA) has published a new guidance document titled “Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices”. The guideline provides requirements for medical device wholesalers preparing a Site Master File (SMF) as part of medical device establishment licence applications in South Africa. The guidance applies to wholesalers of medical devices, including In Vitro Diagnostic medical devic