Reporting of serious incidents and field safety corrective actions
1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:
(a) any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;
(b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92.
2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.
3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.
4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person’s state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.
7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5.
8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being undertaken.
9. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 89(9), in consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.
10. The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1.
The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.
11. Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 89.
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is an expected undesirable side-effect, which will be covered by trend reporting in accordance with Article 88, it shall provide an explanatory statement. If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 89.
Vigilance is made up of three components:
1) Reporting of serious incidents
2) Field safety corrective actions
3) Potentially reporting the trending of non-serious incidents.
So in Europe, as a manufacturer of medical devices, you have to report Serious incidents, Field safety corrective actions and Trends to the competent authorities. This reporting is to be done using EUDAMED. And vigilance requirements are applicable to all classes of devices. To better understand what to report, we need to understand some definitions.
Let’s start with the reportable incidents which then are:
– Any serious incident,
– Any serious incident leading to death or serious deterioration of health, and
– Serious public health threats.
So these are the incidents that the manufacturer must report to EUDAMED. All of these are obviously serious incidents but with different outcome to the patients.
MDR also states that, after becoming aware of an actual or potentially reportable incident, and even if the manufacturer is uncertain about whether the incident is reportable or not, the manufacturer shall submit a report to EUDAMED within the timeframes required in the MDR.
Below you see a summary of those reporting timeframes for vigilance in MDR. And this is where the different outcome to the patient plays a role. But please note that any reportable event shall be reported without undue delay. So the timelines here are the maximum allowed reporting time from when the manufacturer becomes aware of the incident.
And also, it is stated in MDR that, where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete, followed up by a complete report. So the timelines are important to follow. Also remember that management of vigilance needs to be covered by the manufacturer’s QMS.
When reporting incidents, the manufacturer normally sends in an initial report describing the incident and devices involved, and then later sends in a final report with conclusions and actions related to the incident, after the investigations have been performed. It is the initial report that needs to follow the reporting timeframes. But the manufacturer can also send in a combined initial and final report if the investigation is finalized within the reporting timeframes. Nevertheless, it shall be understood that both an initial and final report OR a combined report is always required.
It is then the competent authorities that are responsible review and follow up on the incident reports in EUDAMED. When reviewing these reports, the competent authorities can request further data from the manufacturer like the manufacturer’s risk assessments if they think it is needed. And also they can decide on potential actions, like demanding the manufacturer to further investigate and take actions or even decide on restrictions to the manufacturer to further sell the devices. Manufacturers shall also be aware that both healthcare professionals and the public can and are basically asked to report serious incidents as well. So it is always important that the manufacturers treat any serious incidents with high priority. Even if it is the competent authorities that have the major responsibility related to vigilance, also the notified body that has issued any EC certificate to a manufacturer that reports an incident will get access to the incident reports in EUDAMED for their considerations of potential actions.
The next thing related to vigilance is the Field safety corrective actions, or sometimes abbreviated FSCA. This means the corrective action or actions taken by a manufacturer to prevent or reduce the risk of a serious incident related to devices that are on the market. So this could be actions taken as results of investigations of reportable events but also if the manufacturer, for any other reason, understands that they need to correct something related to the use of their devices on the market. Meaning that in Europe the manufacturer shall report those Field safety corrective actions to EUDAMED before they are implemented. Except if the actions are extremely urgent and there is a risk of the public health, then these actions shall be taken immediately and reported in parallel. There are no specific timelines stated in the MDR regarding reporting and implementation of these Field safety corrective actions other than that they shall be reported and implemented without undue delay. Then the manufacturer shall ensure that the information about the field safety corrective action taken is brought, without delay, to the attention of users of the device in question by using a field safety notice or just FSN. The field safety notice shall be available in the official Union language or languages in which the field safety corrective action is taken. This FSN shall also be uploaded in EUDAMED. The field safety notice shall include clear identification of the device or devices affected, including the relevant UDIs. Further, the field safety notice shall explain, in a clear way, the reasons for the field safety corrective action and explanation of the malfunction of the device and associated risks with its use. Also the FSN shall clearly define all the actions to be taken by the users.
Then the last thing related to vigilance in Europe is trend reporting. Manufacturers shall report, to EUDAMED, any statistically significant increase:
– in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis
– significant increase in expected undesirable side-effects that could have a significant impact on the benefit-risk analysis that have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.
To summarize this we you could say that the manufacturers shall monitor if there are increases in the frequency or severity of risks that COULD potentially lead to unacceptable risks. So the manufacturers therefore need to specify the definition of WHEN there is a SIGNIFICANT increase of those incidents. So if the manufacturer sees a significant increase in the frequency or severity of these incidents, they shall report this to EUDAMED. And the definition of “significant increase” is up to the manufacturer to specify, but also remember that those methods and definition of significant increase shall be documented in the manufacturers post market surveillance plan.
So to summarize this, we can conclude that there are a lot of vigilance activities to potentially report to EUDAMED under the MDR, and it is quite obvious that the authorities are expecting better and more frequent vigilance reporting according to MDR, compared to the old directives.
MIR, Medical Device Incident Reporting. This is the official template to use for reporting incidents concerning medical devices. Link.
Applicable MDCG guidance documents
Relevant blog posts
About the author
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.