What is the National Vigilance System of Medical Devices?
The system includes an articulated set of rules and material and human resources, aimed at the systematic collection of information concerning medical devices safety use and their scientific evaluation, and foresees that, appropriate measures are taken to protect the health citizens, where justified.
How is the National Vigilance System of Medical Devices?
It consists of a structure that includes:
a) The competent authority through their service responsible for medical devices vigilance;
b) Manufacturers and authorised representatives;
c) Distributors;
d) The units and establishments, public or private provision of health care;
e) Health professionals;
f) Other users;
g) Notified body where applicable.
a) The competent authority through their service responsible for medical devices vigilance;
b) Manufacturers and authorised representatives;
c) Distributors;
d) The units and establishments, public or private provision of health care;
e) Health professionals;
f) Other users;
g) Notified body where applicable.
What are Infarmed duties in the National Vigilance System of Medical Devices?
The Infarmed is responsible for the National System for Vigilance of medical devices having the following functions:
a) Establish, develop and disseminate the most suitable procedures to obtain information about incidents arising from the use of medical devices;
b) Receive, record and evaluate, in a centralized manner, reports of incidents in Portugal;
c) Where necessary, inform the manufacturer of the incident reports submitted by health professionals and other users;
d) Ensure the investigation of incidents and the implementation of preventive or corrective actions to reduce risk;
e) Conduct studies on the performance and safety in the use of medical devices and their benefit-risk;
f) To propose, where appropriate, safety recommendations for the use of medical devices;
g) To disseminate information and provide training in vigilance of medical devices;
h) To collaborate and share information on safety, with other competent authorities and, in case of recall of a medical device, notify the European Commission and the competent authorities of other Member States;
i) Collaborate with other public or private, including universities, in activities relevant to this area.
a) Establish, develop and disseminate the most suitable procedures to obtain information about incidents arising from the use of medical devices;
b) Receive, record and evaluate, in a centralized manner, reports of incidents in Portugal;
c) Where necessary, inform the manufacturer of the incident reports submitted by health professionals and other users;
d) Ensure the investigation of incidents and the implementation of preventive or corrective actions to reduce risk;
e) Conduct studies on the performance and safety in the use of medical devices and their benefit-risk;
f) To propose, where appropriate, safety recommendations for the use of medical devices;
g) To disseminate information and provide training in vigilance of medical devices;
h) To collaborate and share information on safety, with other competent authorities and, in case of recall of a medical device, notify the European Commission and the competent authorities of other Member States;
i) Collaborate with other public or private, including universities, in activities relevant to this area.
What are the manufacturer's obligations within the National Vigilance System of Medical Devices?
a) Communicate to the competent authority all information concerning the means of contact of the representative for medical devices vigilance issues and any modification of these elements;
b) Submit to the competent authority reports of incidents and safety corrective actions occurring in the territory;
c) Send to the competent authorities reports of incidents and safety corrective actions arising in the territory of a State not party to the Agreement on the European Economic Area, when manufacturer or authorised representative is placed in Portugal, or notified body responsible for assessment of the medical device is also located in Portugal;
d) To ensure and maintain a process of systematic review of experience with medical devices in the post-marketing, developing the most appropriate means to implement any safety corrective actions;
e) Investigate incidents, that is aware, involving medical devices for which is responsible, notifying and keeping informed the competent authority of that development;
f) To propose and implement, in line with the competent authority, preventive measures, or corrective action to the results of investigation carried out;
g) Ensure prompt and full, the requests of the competent authority for the provision of additional information necessary to evaluate the benefits and risks arising from the use of a medical device;
h) Collaborate with the competent authority, when requested, in initiatives aimed at improving the functioning of the system.
b) Submit to the competent authority reports of incidents and safety corrective actions occurring in the territory;
c) Send to the competent authorities reports of incidents and safety corrective actions arising in the territory of a State not party to the Agreement on the European Economic Area, when manufacturer or authorised representative is placed in Portugal, or notified body responsible for assessment of the medical device is also located in Portugal;
d) To ensure and maintain a process of systematic review of experience with medical devices in the post-marketing, developing the most appropriate means to implement any safety corrective actions;
e) Investigate incidents, that is aware, involving medical devices for which is responsible, notifying and keeping informed the competent authority of that development;
f) To propose and implement, in line with the competent authority, preventive measures, or corrective action to the results of investigation carried out;
g) Ensure prompt and full, the requests of the competent authority for the provision of additional information necessary to evaluate the benefits and risks arising from the use of a medical device;
h) Collaborate with the competent authority, when requested, in initiatives aimed at improving the functioning of the system.
What must be notified under the National Vigilance System of Medical Devices?
a) any malfunction, failure or deterioration of the features or performance, and any inaccuracy, omission or failure on the label or instructions for use of a device, which may cause or have caused death or serious deterioration in state of health of a patient, user or third party;
b) any indirect harm, following a bad medical decision, related to a medical device, when used according to the instructions supplied by the manufacturer;
c) any technical reasons or medical-related characteristics or the performance of a device for the reasons referred to above, led to a safety corrective action in the Portuguese market by the manufacturer for medical devices of the same type ;
d) Other information that experience shows are to be notified.
In case of doubt incidents should always be notified!
b) any indirect harm, following a bad medical decision, related to a medical device, when used according to the instructions supplied by the manufacturer;
c) any technical reasons or medical-related characteristics or the performance of a device for the reasons referred to above, led to a safety corrective action in the Portuguese market by the manufacturer for medical devices of the same type ;
d) Other information that experience shows are to be notified.
In case of doubt incidents should always be notified!
Who should notify the incident?
Manufacturers must report all incidents to the competent national authority in the country where the incident occurs, so it means that all incidents involving medical devices, in Portugal, must be notified to Infarmed.
Distributors must ensure that all incidents that occur in Portugal, and of which they have knowledge, are reported to Infarmed.
Users (whether health professionals, the patients themselves or a third person accompanying the patient, because of their disability) may voluntary notify Infarmed.
Distributors must ensure that all incidents that occur in Portugal, and of which they have knowledge, are reported to Infarmed.
Users (whether health professionals, the patients themselves or a third person accompanying the patient, because of their disability) may voluntary notify Infarmed.
What are the deadlines for reporting an incident to Infarmed?
The initial report must be submitted within:
a) 2 days, in situations involving a serious threat to public health;
b) 10 days in cases involving death or high risk to health;
c) 30 days, in other cases.
The final report should be submitted as soon as the investigation is considered complete, establishing itself as the limit within 10 days after investigation conclusion.
A follow-up report can be sent, if necessary, according to the agreed date.
a) 2 days, in situations involving a serious threat to public health;
b) 10 days in cases involving death or high risk to health;
c) 30 days, in other cases.
The final report should be submitted as soon as the investigation is considered complete, establishing itself as the limit within 10 days after investigation conclusion.
A follow-up report can be sent, if necessary, according to the agreed date.
What is a serious threat to public health?
Is any event that results in imminent risk of multiple deaths in a short period of time, deterioration in his state of health or illness that requires immediate action, since there is a potential risk to public health. Examples: possibility of transmission of diseases such as HIV infection or Creutzfelt-Jacob.
What are the obligations of the manufacturer when receives an incident notification?
When the manufacturer receives information about an incident that may be related to a medical device should investigate the situation to ascertain the causes and the need to implement safety corrective action, to minimize the risk associated with use of devices. In this sense, the manufacturer must:
- Send to Infarmed an initial report within the statutory period provided with appropriate information, including the measures to be taken immediately in urgent cases. This report must indicate the date of the next report;
- If appropriate, try to recover the medical device from the user, providing all the essential information for the decontamination process in the case of devices already used;
- Review the documentation from batch to rule out any abnormalities in the manufacturing process or quality control;
- Compile the information gathered from similar cases and check if it is still acceptable considering the risk management plan of the medical device;
- Justify the absence of safety corrective action based on information on the risk analysis of the medical device;
- If safety corrective action is taken up, except for recall, it should be justified in terms of risk management established for the medical device.
What documents should be send to Infarmed when it is necessary to implement a safety corrective action in Portugal?
- Field safety corrective action report;
- Field safety notice written in Portuguese;
- Form-response;
- List of national users;
- Expected date for conclusion of the action in Portugal.
What are the deadlines for notification of field safety corrective action to Infarmed?
The report of field safety corrective action and its field safety notice should be submitted two days before the proposed date to begin the action implementation, except in cases of serious threat to public health.
In cases of serious threat to public health, the safety corrective action must be initiated immediately and notified to the competent authority, not being the beginning of this action influenced by the response of the competent authority.
The reconciliation report or information on the completion of corrective action must be sent to Infarmed the agreed date.
In cases of serious threat to public health, the safety corrective action must be initiated immediately and notified to the competent authority, not being the beginning of this action influenced by the response of the competent authority.
The reconciliation report or information on the completion of corrective action must be sent to Infarmed the agreed date.
Who has to submit to Infarmed documents relating to field safety corrective action?
In general, it is the responsibility of the manufacturer to define the corrective action to be implemented and its report and also the contents of field safety notice. However, the documentation may be sent by the manufacturer or its representative or distributor.
