EU MDR / IVDR
5 articles
CE Marking for Medical Devices: Requirements, Process, and Conformity Assessment Under EU MDR
The complete guide to CE marking medical devices under EU MDR — classification, conformity assessment routes, Notified Body selection, technical documentation, and step-by-step process.
Clinical Evaluation Report (CER) for Medical Devices: The Complete Guide
How to write a Clinical Evaluation Report that meets EU MDR requirements and passes Notified Body review — methodology, structure, literature search strategy, and common pitfalls.
EU MDR and IVDR: The Complete Guide to European Medical Device Regulation
The definitive guide to EU MDR (2017/745) and IVDR (2017/746) — covering classification rules, conformity assessment, technical documentation, EUDAMED, UDI, transition timelines, and practical strategies for manufacturers navigating CE marking in 2026.
UK Medical Device Regulation Post-Brexit: UKCA Marking, MHRA & The Complete Guide
Navigate UK medical device regulation after Brexit — MHRA framework, UKCA vs CE marking, UK Responsible Person, Northern Ireland Protocol, and practical compliance guidance.
IVDR Performance Evaluation: The Complete Guide for IVD Manufacturers
How to conduct performance evaluation under the EU IVDR — scientific validity, analytical performance, clinical performance, classification rules, and what Notified Bodies expect.