Glossary:TAG-00031-Pat-onA

Glossary > Patient information sheet

Patient information sheet
Tag-ID	TAG-00031-Pat-onA
English	Patient information sheet / Patient information leaflet / Participant information sheet
EN Abbr.	PIS / PIL
French	Note d'information au patient / Fiche d'information au participant / Brochure d'information pour le patient
FR Abbr.	NIP / FIP
German	Patienteninformation / Probandeninformation / Aufklärungsschrift / Teilnehmerinformation
DE Abbr.	PI

References

	Scope	Document part	Language	Document
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2	MD	Article 63 Paragraph 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 63 Paragraph 3 – 5	MD	Article 63 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 59 Paragraph 2	IVD	Article 59 Paragraph 2	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5	IVD	Article 59 Paragraph 3 – 5	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2	HM	Article 29 Paragraph 2	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5	HM	Article 29 Paragraph 3-5	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6	MD	5.8.4 - 5.8.6	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5	HM	4.5	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995