The Regulation (EU) 2017/745 (MDR) describes in Article 87 for all manufacturers of medical devices binding requirements for the interpretation of the reporting obligations and harmonized timelines throughout Europe for the reporting of incidents. These

adapted reporting requirements also apply to devices that are placed on the market under the MDD [see Article 120 (3) MDR].

Definition of Reporting Obligations:
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.

It is particularly important to note that non-reporting of expected adverse reactions is only allowed if they are recorded as part of a

trend reporting to the national market surveillance authorities.

A “field safety corrective action” is defined as “corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.” A connection to a (reportable) incident is not a necessary requirement for mandatory reporting an FSCA.

Reporting Timelines
The timelines for reporting incidents have also been redefined:

• serious incidents: immediately, after a (reasonably possible) relationship between the incident and the product have been established, but not later than 15 days after becoming aware of the incident,
• serious public health threat: immediately, but not later than two days, after becoming aware of the threat,
• in the event of death or an unanticipated serious deterioration in a person’s state of health: immediately after the manufacturer has established or suspected a causal relationship between the product and the serious incident, but no later than 10 days after becoming aware of the incident.

(For details see Article 87 MDR).

Reporting Conventions:
The following form, already established in Jan. 2020, shall be used for reporting incidents of both medical devices and in-vitro diagnostics: Manufacturer incident report 2020

Various changes have been implemented in the form, which should be taken into account. In particular, a uniform classification of activities is required (relevant for follow-up and final reports). The necessary catalogs have been published by the IMDRF and are available for download.

The amended timelines, the current report form and the associated documents should be taken into account when updating the process descriptions for handling incidents.

Where to report
In accordance with Article 87, reports should in principle be made via the EUDAMED system. Until the EUDAMED database is fully available, reports on incidents and FSCA shall continue to be made to the National Reporting Points (overview of National Vigilance Contact Points).

In addition, may we remind you of the obligation to also report incident reports and FSCA to the Notified Body. Please use the email address vigilance(at)mdc-ce.de. We kindly ask you to submit both the pdf document and the corresponding XML file to ensure correct recording of the reports.