46 lines
2.2 KiB
Plaintext
46 lines
2.2 KiB
Plaintext
{{RegDocument
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| area_of_validity = EU
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| scope = IVD
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| document_type = Regulation
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| name = In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
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| version = 2017/746, amended by 2022/1107
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746
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| language = EN, DE, FR (all EU official languages)
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| status = Current
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| restricted_access = No
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}}
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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.
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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.
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== Key references ==
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{| class="wikitable" style="width:100%;"
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! Topic / Keyword(s) !! Category / Chapter !! Scope !! Linked document !! Description
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{{Reference
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| topic = Post-market performance follow-up, PMPF
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| category = Clinical
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| scope = IVD
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| linked_document = [[IVDR (EU) 2017/746 – Articles 78–81 & Annex XIII Part B: Post-Market Performance Follow-Up]]
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| description = Articles 78–81 and Annex XIII Part B define the mandatory post-market performance follow-up (PMPF) system, equivalent to PMCF under MDR.
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}}
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{{Reference
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| topic = Unique Device Identification, UDI, Traceability
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| category = Labelling
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| scope = IVD
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| linked_document = [[IVDR (EU) 2017/746 – Articles 24–26 & Annex VI: UDI]]
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| description = Articles 24–26 and Annex VI establish the UDI system for IVDs, aligned with the MDR UDI framework.
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}}
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{{Reference
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| topic = Performance evaluation, Scientific validity
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| category = Clinical
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| scope = IVD
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| linked_document = [[IVDR (EU) 2017/746 – Article 56 & Annex XIII Part A: Performance Evaluation]]
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| description = Article 56 and Annex XIII Part A define performance evaluation requirements, including analytical performance, clinical performance, and scientific validity.
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}}
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|}
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[[Category:In Vitro Diagnostics]]
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[[Category:EU Regulation]]
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