MDCG guidance
MDCG 2020-14: Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)
MDCG guidance · Notified bodies · August 2020
Key facts
| Reference | MDCG 2020-14 |
|---|---|
| Title | Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) |
| Topic | Notified bodies |
| Published | August 2020 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2020-14 (August 2020) 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.