Glossary:TAG-00213-Ser-wie

Glossary > Serious incident

Serious incident
Tag-ID	TAG-00213-Ser-wie
English	Serious incident / Serious adverse device effect
French	Incident grave / Effet indésirable grave lié au dispositif
German	Schwerwiegendes Vorkommnis / Schwerwiegendes gerätebezogenes Vorkommnis

References

	Scope	Document part	Language	Document
DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2	MD	§ 2	DE	DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2	MD	Article 87 Paragraph 1 – 2	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5	MD	Article 87 Paragraph 3 – 5	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5	IVD	Article 82 Paragraph 3 – 5	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51	MD	3.51	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020