MDCG guidance
Manual on Borderline: Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.
MDCG guidance · Borderline and Classification · December 2022
Key facts
| Reference | Manual on Borderline |
|---|---|
| Title | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. |
| Topic | Borderline and Classification |
| Published | December 2022 |
| Document | health.ec.europa.eu |
At a glance
- No Full text searchable in Orca1
- Manual on Borderline (December 2022) Revisions on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.