Regulatory Blog

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 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 ”

If you're developing a medical device or in vitro diagnostic (IVD) and need clarity on UK regulatory requirements, the MHRA offers a dedicated paid advisory meeting service. This guidance, " Medical devices: get regulatory advice from the MHRA " is particularly useful when the application of existing regulations to your specific device or situation isn't straightforward. Here's a full breakdown of how the service works. What it's for The service is designed to provide regulat

Clinical trials play a critical role in evaluating the safety and effectiveness of medicines before they are made available to patients. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance to help sponsors and researchers comply with regulatory requirements for clinical trials involving medicinal products. This article provides a consolidated overview of MHRA guidance covering several key areas of clinical trial regulation,

South Africa continues to strengthen regulatory efficiency and regional collaboration through structured reliance pathways. The SAHPRA Medical Devices Reliance Guideline and the ZAZIBONA Centralised Procedure – SAHPRA’s Reliance Process collectively demonstrate SAHPRA’s commitment to regulatory convergence within the SADC region. Guidance: Medical Devices Reliance Guideline – SAHPRA’s Structured Reliance Framework The Medical Devices Reliance Guideline outlines the principle

The Food and Drug Administration (FDA) Philippines has issued a draft guideline for public comments outlining regulatory expectations for medical device establishments regarding record maintenance and post-market reporting. The draft provides structured guidance on importation and distribution records, product complaint handling, adverse event reporting, and field safety corrective actions (FSCAs). This guidance aims to strengthen traceability, post-market surveillance, and

Australia’s Therapeutic Goods Administration (TGA) continues to strengthen regulatory clarity through updated guidance documents covering medical devices and over-the-counter (OTC) medicines. Guidance: Complying with Unique Device Identification requirements for medical devices – TGA The TGA’s guidance on Unique Device Identification (UDI) requirements outlines the regulatory framework for assigning and maintaining UDIs for medical devices supplied in Australia. The UDI sy

In the transforming regulatory landscape for medical devices and in vitro diagnostics (IVDs), understanding the requirements for registration and market entry across the UK—especially in Great Britain (GB) and Northern Ireland (NI)—is essential for manufacturers, authorised representatives, and regulatory professionals. Post-Brexit regulatory divergence has resulted in distinct registration and conformity requirements in Great Britain versus Northern Ireland. Guidance: Regis

In February 2026, FDA issued an updated guidance titled Computer Software Assurance for Production and Quality Management System Software , superseding the September 2025 version. In parallel, FDA released an updated Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions guidance, reflecting the growing cyber risk associated with digital and connected medical technologies. Together, these guidances signal a shift awa

As innovation in healthcare rapidly expands across digital health, medical devices, and advanced clinical trial designs, regulatory expectations must evolve in parallel. Recognising this shift, the US Food and Drug Administration (FDA) released and updated several key guidance documents in January 2026 , offering clarity on how emerging technologies and novel scientific approaches should be developed, evaluated, and regulated. These guidances collectively address clinical dec

In the ever-evolving world of pharmaceutical and medical product regulation, correctly classifying your product is crucial. Some products fall into a “grey area” where they could be regulated as a medicinal product, a medical device, or another type of product such as a cosmetic, food supplement, or biocide. To help manufacturers and other stakeholders make this determination, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) publishes detailed guidance on h