MDCG guidance
MDCG 2019-11 rev.1: Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG guidance · New technologies · June 2025
Key facts
| Reference | MDCG 2019-11 rev.1 |
|---|---|
| Title | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
| Topic | New technologies |
| Published | June 2025 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2019-11 rev.1 (June 2025), MDCG 2019-11 (October 2019) 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.