View source for Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5

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Paragraph 3 – 5
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{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| IVD
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! Document part
| Article 82
Paragraph 3 – 5
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Reporting of FSCAs and serious incidents (IVDR)
|}

== Content ==
Reporting of serious incidents and field safety corrective actions

3.   Manufacturers shall report any serious incident as referred to in point (a) immediately after they have established a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.

4.   Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.

5.   Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.