Absorbed / Dispersed Substances
MDR Reference: Annex I, GSPR 12; Classification Rule 21
Service Item ID: mdr_sec06_absorbed_substance
Applicability: Devices incorporating substances that are absorbed by or locally dispersed in the human body
Overview
Devices that introduce substances intended to be absorbed by or locally dispersed in the body (other than those covered by drug-device combination rules) require additional pre-clinical evidence. MDR Rule 21 classifies such devices as Class III.
Key Requirements
- ADME studies: Absorption, Distribution, Metabolism, Excretion characterisation
- Local tolerance: Tissue response at the application site
- Drug interactions: Potential interactions with concomitant medications
- Toxicity testing: Systemic and local toxicity of the absorbed substance
- Pharmacokinetic data: Substance concentration profiles over time
Key Deliverables
| Document | Description |
|---|---|
| ADME Study Reports | Pharmacokinetic characterisation |
| Local Tolerance Studies | Tissue response assessment |
| Toxicity Assessment | Systemic and local toxicity data |
| Drug Interaction Analysis | Potential interactions with medications |
| Substance Characterisation | Purity, stability, degradation products |
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 12 | Devices incorporating substances absorbed or locally dispersed |
Related Topics
- Drug-Device Combination -- Devices incorporating medicinal substances
- Biocompatibility -- Biological evaluation of the substance
- CMR / Endocrine Disrupting Substances -- Chemical substance risk assessment