Master Drug-Device Combinations
23+ guides. 5 learning paths. EU regulatory clarity.
Choose your starting point below.
Choose Your Learning Path
Click a cluster to jump directly to your curated content.
Fundamentals
Build Your Foundation
(know the landscape)
EMA Q&A Deep Dive
Expert Interpretation
(interpret with confidence)
Procedures & Processes
Navigate the System
(navigate without delays)
Practical Implementation
Submission-Ready
(submit without clock stops)
Case Studies
Real-World Examples
(learn from real approvals)
New to drug-device combinations?
Take the assessment quizNew to DDCs → Solid Foundation
Master the core concepts of drug-device combination regulation. Start here to build a solid understanding of MDR, IVDR, classification, and PMOA.
Continue Your Journey — 11 Guides
MDR 2017/745 for Drug-Device Combinations: What Every RA Professional Must Know
EU MDR requirements for drug-device combinations explained. Learn about GSPRs, classification rules, conformity assessment pathways, and how MDR interfaces with pharmaceutical legislation.
Companion Diagnostics Under IVDR: Complete Regulatory Guide for CDx Development
Navigate IVDR requirements for companion diagnostics. Learn classification rules, performance studies, consultation procedures, and labeling requirements for CDx devices in the EU.
Classification Rules for Drug-Device Combination Products Under EU MDR
Master MDR classification rules for combination products. Learn how PMOA, device function, and pharmaceutical interface determine your regulatory pathway under Rule 14 and Rule 22.
Principal Mode of Action (PMOA) Determination for Drug-Device Combinations
How to determine PMOA for borderline drug-device products. Learn the assessment framework, MDCG guidance interpretation, and when to seek regulatory advice.
Integral vs Co-Packaged Combinations: Regulatory Pathways and Key Differences
Understand the three cumulative conditions distinguishing integral from co-packaged drug-device combinations. Learn classification impacts, labeling differences, and grey area navigation.
Medicinal Product vs Medical Device: How to Determine Product Classification
Learn how to determine whether your product is a medicinal product or medical device. Understand principal intended action, borderline assessment procedures, and regulatory consultation options.
How to Select a Notified Body Under EU MDR: The 5-Step Selection Guide
Select the right Notified Body for EU MDR certification. Learn the 5-step process: NANDO check, scope verification, capacity assessment, location, and experience evaluation.
MDR Clinical Investigations: Requirements, Exemptions & Practical Guidance
Navigate clinical investigation requirements under EU MDR 2017/745. Learn about Article 62 exemptions, sufficient clinical data pathways, and device-specific considerations.
MDCG Guidance Documents: A Practical Navigation Guide for EU MDR Compliance
Navigate 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.
EU vs US Drug-Device Regulation: What Changes Everything
Compare EU MDR and FDA regulatory approaches for drug-device combination products. Learn key differences in classification, assessment, and approval pathways for cross-border regulatory strategy.
DDC Approval Timeline: Every Milestone from Start to Finish
Complete timeline for drug-device combination product approval in the EU. From Notified Body engagement through MAA assessment, clock stops, Commission decision, and market access milestones.
EMA Guidance → Expert Interpretation
Deep analysis of EMA Q&A documents with practical interpretation. Understand what the official guidance really means for your submissions.
Continue Your Journey — 3 Guides
Borderline Products: The Advice Pathway Nobody Maps
Navigate EMA Q&A Q2 on borderline product advice. Learn which authority to approach (NCA, EMA ITF, or MDCG), when to seek formal vs informal advice, and practical steps to get definitive classification.
Integral DDC Labeling: The CE Mark Trap Nobody Warns You About
Deep analysis of EMA Q&A Q3-4 on labeling requirements for integral drug-device combinations. Learn why CE marks don't belong on iDDC packaging, how to integrate device IFU into SmPC, and the labeling traps that delay submissions.
Co-Packaged DDCs: Two Products, Two Sets of Rules
Deep analysis of EMA Q&A Q5-6 on co-packaged drug-device requirements. Learn CE marking obligations, dual labeling frameworks, alternative solutions for small devices, and manufacturer responsibilities under MDR.
Coming Soon — 2 Guides in Development
Q&A Deep Dive: Consultation Procedure for Ancillary Substances
EMA guidance on ancillary medicinal substance consultation procedures (Q7-9).
Q&A Deep Dive: Companion Diagnostic Consultation
Understanding the companion diagnostic consultation procedure (Q10-12).
Know the Rules → Navigate the Process
Step-by-step procedural guidance for consultations, variations, and lifecycle management. Know exactly what to do at each regulatory milestone.
Continue Your Journey — 2 Guides
EMA Variations Framework 2026: What Changed and How It Affects Your Submissions Starting January 15
Comprehensive 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.
EU MDR Conformity Assessment Procedures: Which Route for Your Device?
Complete 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.
Coming Soon — 6 Guides in Development
How Notified Bodies Consult with EMA
Understanding the Notified Body consultation process and timelines.
Companion Diagnostic Consultation Procedure
EMA consultation procedures specific to companion diagnostics.
Lifecycle Management for Combination Products
Managing your DDC through its lifecycle: variations, renewals, and regulatory changes.
Renewal Procedures for Combination Products
Marketing authorization renewal requirements for drug-device combinations.
+ 2 more guides planned
Ready for Implementation?
These paths cover hands-on implementation and real-world case studies for experienced RA professionals.
Theory → Submission-Ready
Hands-on implementation guides with checklists, templates, and common pitfalls. Turn regulatory knowledge into submission-ready documentation.
Continue Your Journey — 3 Guides
Technical Documentation Structure Under EU MDR: Complete Annex II Guide
Master MDR technical documentation requirements. Learn the 6 documentation sections, GSPR compliance, and how to structure your technical file for Notified Body review.
UDI Requirements Under EU MDR: Implementation Guide for Device Manufacturers
Complete guide to Unique Device Identification (UDI) under MDR. Learn UDI-DI vs UDI-PI, EUDAMED registration, carrier requirements, and issuing entity selection.
5 Fatal Pitfalls in Drug-Device Submissions (And How to Avoid Them)
Avoid costly clock stops in DDC submissions. Learn the 5 most common pitfalls: PMOA errors, missing NB opinions, GSPR gaps, labeling mistakes, and lifecycle oversights.
Coming Soon — 6 Guides in Development
Labeling Requirements Checklist for DDCs
Comprehensive checklist for labeling drug-device combination products.
Quality Documentation Requirements (Module 3.2.R)
What to include in Module 3.2.R for combination product submissions.
Clinical Data Requirements for DDCs
Clinical evidence requirements specific to drug-device combinations.
Vigilance and Incident Reporting
Incident reporting requirements at the interface of MDR vigilance and pharmacovigilance.
+ 2 more guides planned
Read About It → See It Applied
Real-world case studies showing regulatory pathways in action. Learn from actual approval scenarios across different product types.
Coming Soon — 3 Guides in Development
Case Study: Pre-filled Syringe Combination
Real-world regulatory pathway analysis for a pre-filled syringe DDC.
Case Study: Autoinjector Combination
Regulatory lessons from autoinjector combination product approvals.
Case Study: Companion Diagnostic Development
CDx development pathway with parallel drug-device regulatory strategy.
Need Instant Regulatory Answers?
RegulatorySense delivers AI-powered guidance backed by authoritative EMA documents. Get answers in seconds, not hours.