In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
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This is the approved revision of this page, as well as being the most recent.
| Document Information | |
|---|---|
| Area of validity | EU |
| Scope(s) | IVD |
| Document type | Regulation |
| Document name | In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 |
| Version / Revision | 2017/746, amended by 2022/1107 |
| Official source | Official link |
| Language(s) | EN, DE, FR (all EU official languages) |
| Status | Current |
| Restricted access | No |
The In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 replaces the former IVD Directive (IVDD 98/79/EC). It introduces a significantly stricter framework for in vitro diagnostic medical devices, including reclassification of the majority of IVDs into higher risk classes requiring Notified Body involvement.
Full application started on 26 May 2022. The amendment 2022/1107 introduced a phased transition for legacy devices based on device class and Notified Body capacity.
Key references
| Topic / Keyword(s) | Category / Chapter | Scope | Linked document | Description |
|---|---|---|---|---|
| Post-market performance follow-up, PMPF | Clinical | IVD | IVDR (EU) 2017/746 – Articles 78–81 & Annex XIII Part B: Post-Market Performance Follow-Up | Articles 78–81 and Annex XIII Part B define the mandatory post-market performance follow-up (PMPF) system, equivalent to PMCF under MDR. |
| Unique Device Identification, UDI, Traceability | Labelling | IVD | IVDR (EU) 2017/746 – Articles 24–26 & Annex VI: UDI | Articles 24–26 and Annex VI establish the UDI system for IVDs, aligned with the MDR UDI framework. |
| Performance evaluation, Scientific validity | Clinical | IVD | IVDR (EU) 2017/746 – Article 56 & Annex XIII Part A: Performance Evaluation | Article 56 and Annex XIII Part A define performance evaluation requirements, including analytical performance, clinical performance, and scientific validity. |
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