MDCG guidance
MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
MDCG guidance · Borderline and Classification · April 2022
Key facts
| Reference | MDCG 2022-5 |
|---|---|
| Title | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices |
| Topic | Borderline and Classification |
| Published | April 2022 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2022-5 (April 2022) Revisions on file
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About MDCG guidance documents
The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.