Manufacturers’ Responsibilities

As might be expected, a manufacturer in charge of medical device production has a significant list of responsibilities when he or she is seeking to conform to European Medical Device Vigilance System guidelines. These responsibilities include the following:

• Notify NCAs (National Competent Authorities) when medical device incidents occur or in regards to field safety corrective actions;

• Ensure that field safety corrective actions and incidents comply with reporting criteria

• Investigate medical device incidents;

• Participate in the application of corrective actions;

• Communicate effectively with all authorized representatives (who may be located in the EEA and/or in Switzerland) in regards to incidents, MEDEV-5 guidelines and FSCAs (Field Safety Corrective Actions);

• Communicate with marketing and additional agents in regards to transpired incidents;

• Submit multiple reports for incidents that encompass multiple devices (one for each device);

• Communicate with “the notified body advised of issues occurring in the post production phase affecting the certification. This would include relevant changes derived from the vigilance system;”

• Provide reports according to the methods assigned by the European Vigilance System even when medical devices have ceased to be listed via the market;

• Submit initial AND final reports regarding medical device incidents;

• Determine the relevance of incidents that occur outside of the EEA and/or Switzerland on processes (etc.) that occur within the EEA and/or Switzerland. When an incident is determined to be relevant manufacturers should file a field safety corrective action;

• Identify a point of contact within Switzerland and the EEA where action can be taken if a manufacturer is normally located outside of these areas.

Manufacturers’ Responsibilities: Identifying Incidents According to MEDDEV-5 Criteria

Since one of the primary responsibilities of medical device manufacturers in regards to the European Medical Device Vigilance System is to report incidents that meet specific criteria, the MEDDEV-5 text divides the criteria into three parts:

1. “An Event has Occurred”

According to MEDDEV-5 criteria, an event has occurred when:

• Device malfunctions affect the ability of a device to perform;

• Tests performed via a device result in false conclusions;

• Device promotes a patient reaction that was unexpected;

• Device promotes a side effect that was unexpected;

• A device has been destroyed;

• A device has been abused or degraded;

• Therapy that relies on the device has been offered inappropriately;

• Medical device labels are not accurate.

2. “The Device Contributed to the Incident”

According to the MEDDEV-5 criteria a device contributed to an incident when healthcare professionals opine that the device was related to the incident in question; a manufacturer opines (after appropriate investigation) that the device was related to the incident in question; incidents similar to the incident in question have occurred.

3. “The Event Could Have Resulted in a Problem”

According to the MEDDEV-5 criteria, an event could have resulted in a problem when: the incident in question could possibly have resulted in a death(s); the incident in question could possibly have resulted in the deterioration of a patient’s health.

Page : 1  |  2 | 3

Back | Next