Europe: Medical Device Incident Reporting

Each year, the regulatory authorities receive several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Incident Reporting system helps in monitoring device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

According to the Medical Device Regulation (MDR 2017/745), 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. The respective reports shall be submitted through the electronic system referred to in Article 92 and the period for the reporting shall take account of the severity of the serious incident. 
• c. Manufacturers shall report any serious incident 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. 
• d. In the event of a serious public health threat, the report shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
• e. 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.
• f. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.
• g. 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. 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 in advance of the field safety corrective action being undertaken.
• h. 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.
• i. 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.
• j. Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report 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.
• k. 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.

The Member States shall take appropriate measures such as organizing targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities about the suspected serious incidents. These reports, along with data from other sources, can provide critical information that helps improve patient safety. 

Once a competent authority of a Member State obtains reports on suspected serious incidents 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. The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.