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 […]
Clinical Investigation 101 for Medical Devices: Importance, Process, and Compliance with EU MDR
Clinical investigations are essential in the development and regulation of medical devices, ensuring their safety, efficacy, and performance. Under the European Medical Device Regulation (MDR) 2017/745, clinical investigations have become more structured and rigorous, requiring thorough planning, precise execution, and compliance with regulatory frameworks. In this blog, we’ll explore what clinical investigations entail, why they […]
Breaking Barriers in Women’s Health
Zara Malik, Head of Regulatory Affairs at LFH Regulatory had the privilege of attending the Innovation in Women’s Health webinar hosted by the Association of British HealthTech Industries (ABHI), and chaired by Women’s Health Ambassador, Dr Henrietta Hughes. The session brought together a vibrant group of #STEMinists — professionals united by a shared mission to […]
Custom Made Devices – How Are Custom-Made Medical Devices Regulated in the EU?
Are you a medical device manufacturer wondering how custom-made devices (CMDs) are regulated in the EU? Under Medical Devices Regulation (MDR) 2017/745, CMDs must comply with strict requirements to ensure safety and performance. This guide provides a clear breakdown of CMD compliance steps, key documentation requirements, and common challenges faced by manufacturers. The medical device […]