MDCG guidance
MDCG 2020-1: Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
MDCG guidance · New technologies · March 2020
Key facts
| Reference | MDCG 2020-1 |
|---|---|
| Title | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software |
| Topic | New technologies |
| Published | March 2020 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2020-1 (March 2020) 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.