Your Questions Answered
I have submitted an initial incident report, is there a timeline within which I have to submit follow-up and final incident reports?Although the European Commission guidance MEDDEV 2.12/1 Guidelines on a Medical Device Vigilance system does not explicitly state when follow up reports should be submitted to the Competent Authorities, a general rule of thumb would be to submit a follow up report as soon as additional information becomes available or in the absence of additional information, 30 days post submission of the initial report. Note – Certain individual Competent Authorities may have their own expectations in terms of timelines for submission of follow up reports – e.g. 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 to the E.U. ?Incidents which occur outside of the EEA, Switzerland & Turkey and do not result in a Field Safety Corrective Action do not need to be reported to the National Competent Authorities under the European medical device vigilance system. However, incidents which occur outside the EEA, Switzerland & Turkey and do result in a Field Safety Corrective action for these geographical areas do need to be reported to the relevant Competent Authorities.
Who is responsible for submitting the Incident Report?As per the European Commission guidance MEDDEV 2.12/1 Guidelines on a Medical Device Vigilance, 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 user errors?User errors are deemed reportable where death or serious deterioration in health has occurred. User errors which did not result in death or serious deterioration of health do not need to be reported by the Manufacturer to the national competent Authority. Such events should be handled internally by the Manufacturer under their own quality and risk management system. All user errors should be trended and may become reportable on detection of a significant trend. The European Commission guidance MEDDEV 2.12/1 Guidelines on a Medical Device Vigilance also consider abnormal use. Whilst user error constitutes an unintentional misuse of the device by the user, abnormal use is deviating from normal use of the device (e.g. off-label use, untrained use). Under MEDDEC 2.12/1 , the Manufacturer does not need to report abnormal use to the Competent Authority. As a general rule of thumb, there should be a pre-disposition to report rather than not to report where doubt exists in terms of event reportability.
How We Can HelpIf you require support with reportability decision making or with the submission of Manufacturer Incident Report Form/s to the Competent Authority/ Authorities, contact us here at Acorn Regulatory or complete your details below. [ninja_form id=1]
- 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