EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions
In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD and medical device manufacturers. In this article, we are going to delve a bit deeper and answer some questions about vigilance reporting that we are regularly asked by clients.
I have submitted an initial incident report, is there a timeline within which I have to submit follow-up and final incident reports?
You need to provide the Competent Authority with follow-up information that becomes available after submission of an Incident Report in a timely manner. There are no guidelines specified in the European Commission guidance MEDDEV 2.12/1 as to the timelines for follow up reports1. It is advisable to keep the Competent Authority informed of progress, even if it is to report slower progress than expected. However, it should be noted that individual Competent Authorities may have their own expectations in respect of timelines, for example the UK Competent Authority MHRA expect that follow-up reports are submitted within 30 days of initial Incident Reports2 or as negotiated with the MHRA.
Do I have to report incidents that occurred outside the jurisdiction?
No. The IVD and medical device directives are adopted in 33 European countries – 28 EU members, 3 EEA members (Norway, Iceland and Lichtenstein), 1 EU candidate country (Turkey) and Switzerland. Incidents which occur outside of these countries do not need to be reported to the national Competent Authorities under the European medical device vigilance system.
Who is responsible for submitting the Incident Report?
Under the European system, incident reports can be submitted by either the Manufacturer or the EU Authorised Representative. Irrespective of who submits the report, the legal Manufacturer maintains full responsibility for the safety and performance of the product.
Do I have to submit an Incident Report for an event that is reported in literature or social media?
There is no requirement for pro-active screening of scientific literature or social media under the IVD and medical devices legislation. However, there is a requirement to submit reports to the regulatory authority when a Manufacturer (meaning any employee or representative) “becomes aware” of reportable incidents from any source. This would include sources such as literature and social media. Allegations from such sources should be logged in the Manufacturer’s complaint system and assessed for vigilance reporting using the criteria outlined in European Commission guidance MEDDEV 2.12/11.
Do I need to report use errors?
Under the European system, use errors are only reportable where death or serious deterioration in health has occurred. Use errors which did not result in death or serious deterioration in health are not ordinarily reportable. However, all use errors must be trended and may become reportable on detection of a significant trend.
Abnormal use is defined separately from use error under the European system. Whilst use error constitutes an unintentional misuse of the device by the user (slip, lapse or mistake), abnormal use is intentional misuse (e.g. off-label, contraindicated use, sabotage, untrained use). Death or serious deterioration in state of health which occurred as a result of abnormal use is not reportable by the Manufacturer.
As a general principle, there should be a pre-disposition to report rather than not to report in case of doubt on whether or not an event is reportable. Submitting an Incident Report is not an admission of liability.
However, if you are unsure of the requirements or need support in making your determination or in submitting the forms to the Competent Authority, contact us here at Acorn Regulatory or complete your details below.
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- Guidelines on a Medical Device Vigilance System. European Commission Guidance, MEDDEV 2.12/1 Revision 8 http://ec.europa.eu/growth/sectors/medical-devices/documents/guidelines/index_en.htm
- Directives Bulletin no. 3 Guidance on the operation of the EU vigilance system in the UK, September 2008. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/403818/Directives_Bulletin_no3.pdf