Essential Requirement 2 states: ?The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state-of-the-art.? This means documents and standards that are safety related, relevant to the intended purpose and considered state-of-the-art must be taken into account and solutions adopted that are identical or conform to the same safety principles.
MEDDEV guidances are considered as the state-of-the-art standards with regards to the essential requirements of Directive for Active Implantable Medical Devices (AIMD), 90/385/EEC, therefore MEDDEV 2.12-1 rev 8 Vigilance guidance must be followed for the determination of the timescale for the initial reporting.
TIMESCALE FOR THE INITIAL REPORTING OF AN INCIDENT
Upon becoming aware that an event has occurred and that one of its devices may have caused or contributed to that event, the MEDICAL DEVICE MANUFACTURER must determine whether it is an INCIDENT.
The following time lines apply in a case of:
Serious public health threat: IMMEDIATELY (without any delay that could not be justified) but not later than 2 calendar days after awareness by the MANUFACTURER of this threat.
Death or UNANTICIPATED serious deterioration in state of health: IMMEDIATELY (without any delay that could not be justified)
after the MANUFACTURER established a link between the device and the event but not later than 10 elapsed calendar days following the date of awareness of the event.
Others: IMMEDIATELY (without any delay that could not be justified) after the
MANUFACTURER established a link between the device and the event but not later than 30 elapsed calendar days following the date of awareness of the event.
If after becoming aware of a potentially reportable INCIDENT there is still uncertainty about whether the event is reportable, the MANUFACTURER must submit a report within the timeframe required for that type of INCIDENT
