MDCG guidance
MDCG 2019-15 rev.1: Guidance notes for manufacturers of class I medical devices
MDCG guidance · Class I Devices · December 2019
Key facts
| Reference | MDCG 2019-15 rev.1 |
|---|---|
| Title | Guidance notes for manufacturers of class I medical devices |
| Topic | Class I Devices |
| Published | December 2019 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2019-15 rev.1 (December 2019) 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.