EU MDR / IVDR
113 articles
EU MDR and IVDR Transition Timeline: Legacy Device Deadlines (2026-2029)
Guide to EU MDR and IVDR transition deadlines for legacy devices, including Articles 120 and 110, class-specific dates, eligibility conditions, EUDAMED, and market access.
How to Choose a Medical Device Regulatory Consultant: Complete 2026 Evaluation Guide
Evaluate medical device regulatory consultants with selection criteria, interview questions, red flags, pricing benchmarks, RAC/RAPS signals, and a stage-based decision framework.
EU IVDR Classification Rules: The Complete Guide to IVD Risk Classes A–D
Practical guide to IVDR Annex VIII classification rules for IVD Classes A-D, with device examples, software guidance, IVDD-to-IVDR changes, and the 2025 EU simplification proposal.
EU MDR Notified Bodies and Conformity Assessment Guide
Guide to EU MDR Notified Bodies and conformity assessment, including NB selection, routes by device class, audits, timelines, costs, and 2025-2026 regulatory context.
EUDAMED Registration Guide for Medical Device and IVD Manufacturers
Step-by-step EUDAMED registration guide covering SRN actor registration, UDI/device data, Notified Body certificates, market surveillance, May 2026 deadlines, and legacy devices.
Medical Device Technical File: EU MDR Documentation Guide
Prepare EU MDR technical documentation for medical devices, including Annex II and III content, FDA DHF comparisons, STED format, ISO 13485 files, and practical assembly steps.
EU MDR PMCF Guide: Plans, Studies, Reports, and Implementation
Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.
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.