FDA Medical Device Classification and 510(k) Exemptions Explained
Understanding how the FDA classifies medical devices is essential for any manufacturer planning to enter the United States. Classification determines the regulatory controls that apply, the premarket submission required and the level of evidence the FDA expects. It also influences commercial strategy because timelines, cost and feasibility vary significantly between classes. The transcript outlines the […]
Proposed EU MDR and IVDR Changes, What the Reforms Mean for Manufacturers
The European Commission has proposed the most significant amendments to the EU Medical Device Regulation and In Vitro Diagnostic Regulation since their entry into force. These changes are intended to correct well-documented implementation challenges, reduce unnecessary regulatory burden, improve predictability and protect patient access, while maintaining high standards of safety and performance. For manufacturers, the […]
EU MDR/IVDR Technical File vs FDA Device Master Record: What Manufacturers Need to Know
Medical device manufacturers expanding into both the European Union and the United States often face a familiar question: Are the EU MDR/IVDR Technical File and the FDA Device Master Record (DMR) the same thing? At first glance, both sets of documentation describe how a device is designed, manufactured, and verified for safety and performance. Yet […]
The Risks of Misclassification in Medical Devices: Why Getting It Right Matters
Correct classification is the foundation of medical device compliance. It determines the regulatory pathway, the level of scrutiny, the depth of technical documentation required, and the evidence needed to demonstrate safety and performance. Both the MHRA and EU authorities are ramping up oversight and identifying more products on the market that do not meet the […]
FDA Draft Guidance: Quality Management System Information for Premarket Submissions (QMSR 2026)
The FDA has released a draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews”, outlining how manufacturers must demonstrate their Quality Management System (QMS) compliance under the upcoming Quality Management System Regulation (QMSR). The QMSR, set to take effect on 2 February 2026, represents one of the most significant changes to U.S. […]
International Recognition of Medical Devices: MHRA’s Policy Explained
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a landmark policy proposal that will reshape how medical devices gain market access in Great Britain. This Statement of Policy Intent on International Recognition, first published in February 2025 and updated in October 2025, sets out how the MHRA plans to recognise medical device […]