MDCG guidance
MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC
MDCG guidance · In Vitro Diagnostic medical devices (IVD) · May 2022
Key facts
| Reference | MDCG 2022-8 |
|---|---|
| Title | Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC |
| Topic | In Vitro Diagnostic medical devices (IVD) |
| Published | May 2022 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2022-8 (May 2022) 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.