According to the European Medical Devices Directive (MDD 93/42/EEC) medical device manufacturers are legally required to report serious adverse incidents and corresponding "Field Safety Corrective Actions" (FSCA) such as a recall or a Field Safety Notice (FSN) to the Authorities. Manufacturers that fail to correctly report incidents could face financial penalties or even criminal sentences.
According to the European Commission’s Guidance document "Meddev 2 12-1 Vigilance" (http://www.ec.europa.eu/health/medical-devices/files/meddev/2_12_1_ol_en.pdf), such an incident report must be filed in case that a device malfunction, a deterioration in device performance, inadequate instructions or inadequate labeling result or may result in death, serious injury, or other serious deterioration of health. Such serious incident must be reported to the competent authority of the member state where the incident occurred and also to the competent authority in the member state where the manufacturer or its Authorized Representative is located if the manufacturer is based outside of the EEA. Ignorance or misinterpretation is not an excuse for not reporting.
Astaris Medtech can help determine when incidents are reportable, help ensure that final incident reports are completed on time, assist in the correct diction and formulation and if being your European Authorised Representative Astaris Medtech can also submit your incident reports to the competent authorities on your behalf. Astaris Medtech offers support in responding correspondence of authorities, in issuing FSNs, or other requirements in case of a serious incident.