EU MDR / IVDR
126 articles
Sustainability & ESG in Medical Devices: Regulations and Best Practices
How sustainability, ESG reporting, and circular economy reshape medical device design, manufacturing, EU CSRD compliance, and lifecycle strategy.
CE Marking for Medical Devices: EU MDR Requirements, Process, and Assessment
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
Complete guide to EU MDR and IVDR for medical device and IVD manufacturers, covering classification, conformity assessment, UDI, EUDAMED, timelines, and CE marking.
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.