Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2

Document information
Reference	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
Validity area	EU
Scope(s)	MD
Document name	Regulation (EU) 2017/745 - Medical Device Regulation
Version / Revision	20-Mar-2023
Status	Current
Document type	Legal act
Language(s)	EN
Description	REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.3.5
Scope	MD
Document part	Article 87 Paragraph 1 – 2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Serious incident, Field safety corrective action, Manufacturer, Incident, Medical device

Content

Reporting of serious incidents and field safety corrective actions

1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;

(b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.

The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92.

2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.