Who should receive a report from the FSCA? When the manufacturer is outside the EEA, an FSCA report must be distributed in the Member State in which the manufacturer or agent is located, in addition to the competent authorities of the Member States where the device is put on the market. A safety note on the ground (FSN) must also be distributed to consumers in these Member States. How can we learn more about the requirements for vigilance reporting in Europe? The European Commission`s MEDDEV 2.12/1 guidance document provides manufacturers with valuable information on terminology, timetables and other requirements for vigilance reporting. Download our free Medical Device Vigilance Reporting in Europe white book photo to get an overview of the types of events announced. The term “vigilance report” includes incident reporting and field safety action (FSCA). According to MEDDEV 2.12/1, an incident report must be reported if a malfunction of the aircraft, deterioration in aircraft performance, inadequate instructions or insufficient marking can result in death or serious injury or, if repeated, cause death or serious deterioration of the health. The incident must be reported to the competent authority (CA) of the Member State where the incident occurred. When a manufacturer takes steps to reduce the risk of death or serious health damage, such as a recall. B, a safety correction report (FSCA) is to be distributed to the certification bodies of the Member States where the device is placed on the market, as well as to the certification body where the manufacturer or its AR is located. The new Medical Devices Regulation (MDR) in Europe deals with specific timetables for FSCA reports. Download our free and detailed white paper for details on the changes made by the MDR regarding the vigilance report: understanding the new regulation on medical devices in Europe. The European Medical Devices Directive (93/42/EEC) and the In vitro Diagnostic Devices Directive (98/79/EC) stipulate that manufacturers of medical devices are legally required to report adverse incidents and safety measures (FSCAs) to the relevant EU authorities.
However, the “when, what and who” aspect of EU incident reports is often perplexing for regulators. Emergo represents more than 1,000 medical device and IVD companies as the EU`s official agent, which is why our team is constantly involved in assisting companies in their vigilance report. The European Commission has published new guidelines to clarify manufacturers` obligations under the medical device monitoring system set up by the Medical Devices Directive (MDD). These are the basic steps to report an incident in Europe: you can find the whole story here on the Emergo Group blog. We have experience in helping hundreds of manufacturers monitor marketing, CE marking, ISO 13485:2016 certification and other regulatory advice services. Companies that do not report incidents correctly could expect serious consequences. Ignorance is not an acceptable excuse not to report incidents, which is why PR professionals need to be proactive. The opinions expressed in this blog post are the author`s only opinions and do not necessarily reflect the opinion MassDevice.com or his collaborators.