How to Structure a Medical Device Technical File for EU MDR/IVDR
Technical file (TF) documentation is a structured compilation of documents demonstrating the device meets the regulatory requirements of the EU MDR 2017/745 and EU IVDR 2017/746. The TF must be compiled to meet the requirements of the EU MDR or EU IVDR, and be retained for the device lifetime: at least 10 years after the […]
Risk Management for MDR and IVDR Compliance in 2025
Understand how ISO 14971-based risk management supports MDR and IVDR compliance, from design to post-market surveillance.
FDA QSR vs ISO 13485: The Crucial Differences You Must Know
Navigating the regulatory landscape for medical devices can be complex, especially when comparing US requirements with other international standards. A common question is:
MHRA PMS Requirements 2025: What UK Device Manufacturers Must Know
Understand the new MHRA post-market surveillance requirements for UK medical devices.
From 16th June 2025, new MHRA PMS requirements are now applicable to all CE and UKCA-marked medical devices placed on the Great Britain (GB) market. These changes, introduced under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368), amend the UK Medical Devices Regulations 2002.
Performance Evaluation Under IVDR: What you Need to Know in 2025
The In Vitro Diagnostic Regulation (IVDR) introduced stricter rules for IVD devices and has fundamentally changed how IVD manufacturers demonstrate the safety and performance of their devices. The requirements for performance evaluation are described within Chapter VI of the IVDR and supported by Annexes I, II, III and XIII. The IVDR, with a special focus […]
How to Manage Risk in SaMD and Avoid Compliance Mistakes
Software as a Medical Device (SaMD) is quickly revolutionising healthcare globally by enabling innovative solutions for diagnosis, treatment, and patient management. Whilst these amazing developments are being made, risk management is critical to ensuring patient safety and compliance with standards (such as ISO 14971) and regulations (such as MDR (EU) 2017/745). It’s critical to have […]