MDCG guidance
MDCG 2023-4: Medical Device Software (MDSW) - Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
MDCG guidance · New technologies · October 2023
Key facts
| Reference | MDCG 2023-4 |
|---|---|
| Title | Medical Device Software (MDSW) - Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components |
| Topic | New technologies |
| Published | October 2023 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2023-4 (October 2023) 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.