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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 or performance of a device leading for the reasons referred to in subparagraph (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 events and recalls as described above. The vigilance guidelines, Guidelines on a Medical Device Vigilance System, MEDDEV 2.12-1 rev. 6 from December 2009, requires IMMEDIATE reporting of incidents and defines IMMEDIATELY as ‘without any delay that could not be justified”. The guidelines distinguishes between three timelines (not later than 2, 10 or 30 calendar days) to allow the review of an event if not immediately to be determined an incident: IMMEDIATELY but not later than 2 calendar days after awareness by the manufacturer of the thread in cases of serious public health thread. IMMEDIATELY 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. IMMEDIATELY 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: http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm. For our clients: Please refer to the Client Area to download the vigilance forms: Client Login As described above, the manufacturer as well is required to inform the competent authority of any Field Safety Corrective Action (recalls and others). Further clarification of a Field Safety Corrective Action can also be found in the vigilance guideline. Status: August 2010
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