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MDSS
serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individually.

The European Medical Device Directives require manufacturers to implement a process to review the experience gained from their 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 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. 5 from April 2007, allows for 10 days for incidents and 30 days respectively for near incidents to be reported to the authorities.  The guidelines also state that a report should be submitted as soon as possible.  The guidelines, however, do not represent the law.  The interpretation is that if the cause of the incident is not clear, the manufacturer has time to evaluate whether the product was actually the reason of the incident. 

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.  However, 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 German DIMDI forms for such purposes.  The forms are issued both in German and English and have been accepted by the various competent authorities in the European Union, since they follow the European vigilance guidelines. 

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 recall.  Further clarification of a recall can also be found in the vigilance guideline. 

Status: September 2005