The European Medical Device Directives require manufacturers to implement a process to review the experience gained from their Medical Devices in the post-production phase. In addition, the requirements stipulate that manufacturers need to notify the Competent Authorities as soon as they are informed of adverse events.
We find such requirements in the various Annexes of the Medical Device Directives
. In Annex II of the MDD 93/42/EEC, for example, it is stated under section 3.1., last bullet point:
"an undertaking by the manufacturer to institute and keep up to date a systematic procedure, including the provisions referred to in Annex X, to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the Competent Authorities of the following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics ir performance of a device leading for the reasons referred to in sub-paragraph (i) to systematic recall of devices of the same type by the manufacturer."
Thus, the manufacturer is required to report to the various Competent Authorities immediately upon learning of adverse event and recalls as described above. The vigilance guidelines, Guidelines on a Medical Device Vigilance System
, MEDDEV 2.12-1 requires IMMEDIATE reporting of incidents and defines IMMEDIATELY as `without any delay that could not be justified'. The guidelines distinguishes between three time-lines (not later than 2, 10 or 30 calender days) to allow the review of an event if not immediately to be determined an incident:
but not later than 2 calendar days after awareness by the manufacturer of the thread in cases of serious public health thread.
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 in cases of death or unanticipated serious deterioration in state of health.
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 in other cases.
The guidelines, however, do not represent the law. The interpretation is that if the cause of the event is not clear, the manufacturer has time to evaluate whether the product was actually the reason of the event which then makes it an incident which must be reported.
Therefore, if established that the product caused the incident, a report should be submitted immediately. Many manufacturers tend to rely on the 10 and 30 days time frames stated in the guidelines, even going as far as to stipulate working days. What must be kept in mind is that if further events could have been prevented during the investigation time, it was not acceptable to delay reporting.
MDSS reports on behalf of its clients
and uses the report forms given Annex 3 and 4 of the guidelines, which can also be found here:
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As described above, the manufacturer as well is required to inform the Competent Authority of the Field Safety Corrective Action (recalls and others). Further clarification of a Field Safety Corrective Action can also be found in the vigilance guideline.
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