In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

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.

0.00

(0 votes)