EU MDR / IVDR
88 articles
Medical Device Technical File: Complete Guide to EU MDR Technical Documentation (Annex II & III)
Comprehensive guide to medical device technical documentation — EU MDR Annex II & III requirements, FDA Design History File comparison, STED format, ISO 13485 medical device file, and step-by-step preparation instructions.
Post-Market Clinical Follow-Up (PMCF) Under EU MDR: Plans, Studies, and the Complete Implementation Guide
A comprehensive guide to PMCF under EU MDR — covering PMCF plan development, study design, evaluation reports, integration with PMS and clinical evaluation, and practical implementation strategies.
Sustainability & ESG in Medical Devices: Regulatory Drivers, Circular Economy, and Industry Best Practices
How environmental sustainability, ESG reporting, and circular economy principles are transforming medical device design, manufacturing, and regulation — covering EU CSRD, FDA green initiatives, lifecycle assessment, and practical implementation strategies.
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.