Regulatory Blog

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

In 2026, several key guidances published on GOV.UK clarify the rules manufacturers, sponsors, and regulators must follow for clinical investigations, market placement, conformity assessment, and exemptions. This blog covers four major guidances released and maintained by the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Government. Collectively, they form an essential framework for anyone involved in medical device development, clinical evaluation, reg

Safety reporting is one of the most critical safeguards in clinical trials involving investigational drugs and medical devices. To ensure that safety information is collected, evaluated, and communicated effectively, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices   (December 2025), and Sponsor Responsibilities — Safety Reporting Requirements and

Placing a medical device or in vitro diagnostic (IVD) on the UK market involves more than product design and manufacturing. Manufacturers must demonstrate regulatory compliance, engage effectively with regulators, and prepare for evolving post-market expectations. To support this, the UK government and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a series of guidances and roadmaps that explain both current requirements and the future direction

Medical device regulation in the UK is designed to ensure that products placed on the market or manufactured for patient use are safe, effective, and appropriately controlled. While most manufacturers are familiar with the general requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002), certain categories of devices and manufacturing scenarios are subject to additional, specific legal provisions. Two important MHRA guidance documents explain these areas in detai

Radiopharmaceuticals present unique quality challenges due to their radioactive nature, short shelf lives, and frequent need for on-site or near-patient preparation. To reflect scientific and technological advances since the original 2007 guideline, the European Medicines Agency has released the draft Guideline on quality of radiopharmaceuticals – Revision 2  for public consultation. Adopted by CHMP in December 2025, this revision provides updated expectations for quality doc

As FDA continues to modernize and digitize its medical device review infrastructure, the updated guidance eCopy Program for Medical Device Submissions  plays a central role in transitioning industry toward fully electronic submissions. The December 2025 revision, reflected in the attached document, expands the technical requirements, clarifies the interaction between the eCopy and eSTAR programs, and incorporates contemporary digital standards needed to support efficient, err

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