MDCG guidance
Helsinki Procedure: Helsinki Procedure for borderline and classification under MDR & IVDR
MDCG guidance · Borderline and Classification · September 2021
Key facts
| Reference | Helsinki Procedure |
|---|---|
| Title | Helsinki Procedure for borderline and classification under MDR & IVDR |
| Topic | Borderline and Classification |
| Published | September 2021 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- Helsinki Procedure (September 2021) 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.