Navigate EU regulatory requirements with confidence.
Practical guidance backed by official EMA documents.
Drug-device combination products under EU MDR explained. Learn about Article 117, integral vs non-integral DDCs, regulatory pathways, and practical steps for regulatory affairs professionals.
Read guideNavigate clinical investigation requirements under EU MDR 2017/745. Learn about Article 62 exemptions, sufficient clinical data pathways, and device-specific considerations.
Read guideMaster PMS requirements under EU MDR. Learn PMS plans, PSUR timelines, trend reporting obligations, and practical implementation strategies for medical device manufacturers.
Read guideComplete guide to MDR Annex IX and Annex XI conformity assessment routes. Learn which pathway applies to your device class and what documentation the Notified Body requires.
Read guideComprehensive guide to EC Variations Guidelines (2025) effective January 15, 2026. Classification code changes, Type IA annual updates, transition rules, and compliance checklists for regulatory professionals.
Read guideNavigate MDCG guidance documents with this practical guide. Find the right document for clinical evaluation, notified bodies, PMS, software, UDI, and borderline products under EU MDR.
Read guideSelect the right Notified Body for EU MDR certification. Learn the 5-step process: NANDO check, scope verification, capacity assessment, location, and experience evaluation.
Read guideMaster MDR technical documentation requirements. Learn the 6 documentation sections, GSPR compliance, and how to structure your technical file for Notified Body review.
Read guideComplete guide to Unique Device Identification (UDI) under MDR. Learn UDI-DI vs UDI-PI, EUDAMED registration, carrier requirements, and issuing entity selection.
Read guideHow to determine PMOA for borderline drug-device products. Learn the assessment framework, MDCG guidance interpretation, and when to seek regulatory advice.
Read guideNavigate the Article 117 consultation procedure for integral drug-device combinations. Learn documentation requirements, timelines, and how to obtain Notified Body opinion.
Read guideAvoid costly clock stops in DDC submissions. Learn the 5 most common pitfalls: PMOA errors, missing NB opinions, GSPR gaps, labeling mistakes, and lifecycle oversights.
Read guideEU MDR requirements for drug-device combinations explained. Learn about GSPRs, classification rules, conformity assessment pathways, and how MDR interfaces with pharmaceutical legislation.
Read guideThese guides are in development. Each will provide practical, EMA-backed guidance on specific regulatory topics.
Key MDR provisions affecting drug-device combinations, from classification to post-market requirements.
Understanding companion diagnostic regulation under IVDR and its intersection with medicinal products.
How to determine device class for integral and co-packaged combinations under MDR/IVDR.
Practical guidance on determining PMOA and its regulatory implications.
Key differences and regulatory implications of integral versus co-packaged products.
Analysis of EMA Q1 guidance on classification of combination products.
How to navigate borderline product queries with EMA and national authorities.
Detailed analysis of labeling requirements from EMA Q&A (Q3-4).
Understanding requirements for co-packaged devices from EMA Q&A (Q5-6).
Complete walkthrough of the Article 117 consultation procedure for DDC manufacturers.
Understanding the Notified Body consultation process and timelines.
EMA consultation procedures specific to companion diagnostics.
Managing variations for drug-device combinations: Type IA, IB, and Type II.
Comprehensive checklist for labeling drug-device combination products.
What to include in Module 3.2.R for combination product submissions.
Clinical evidence requirements specific to drug-device combinations.
PMS requirements when MDR meets pharmaceutical vigilance.
Unique Device Identification requirements for integral and co-packaged DDCs.
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