Drug-Device Combination Studies
MDR Reference: MDR Art.1(8)(9); Annex II, Section 6.2.1
BPG Rev.4 Reference: Section 6.2.1
Service Item ID: mdr_sec06_drug_device
Applicability: Devices incorporating or administered with a medicinal substance
Overview
Drug-device combination products require pre-clinical evidence addressing both the device component and the medicinal substance, including their interaction. The regulatory pathway depends on the primary mode of action (device or drug).
Regulatory Framework
- MDR Art.1(8): Devices incorporating a medicinal substance as an integral part
- MDR Art.1(9): Devices used to administer a medicinal product
- Competent authority consultation: Required for the medicinal substance component
- CTD Module 3: Quality data for the drug substance (CEP/ASMF)
Key Deliverables
| Document | Description |
|---|---|
| Drug Substance CEP/ASMF | Certificate of Suitability or Active Substance Master File |
| Device-Drug Interaction Studies | Compatibility, leachables, stability with drug |
| Non-clinical Data (CTD Module 4) | Pharmacology, toxicology studies |
| Clinical Data (CTD Module 5) | Clinical efficacy and safety of the combination |
| Competent Authority Opinion | Consultation outcome for the medicinal substance |
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 10.4 | Devices incorporating substances: quality, safety, efficacy of substance |
| 12 | Devices incorporating medicinal substances |
Related Topics
- Biocompatibility -- Material compatibility including drug interaction
- Absorbed / Dispersed Substances -- Related requirements