EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’
If you are a manufacturer of an IVD or a medical device, once your product is on the market, you must have an effective system for reviewing and evaluating customer complaints and product issues for any safety concerns. The European Commission guidance MEDDEV 2.12/1 revision 81 should be your first port of call in guiding you on making the determination that an event constitutes a reportable incident. In the first of a two part series on medical device vigilance I’m presenting the Cheat’s Guide to the European vigilance system.
Events which fall under the definition of an ‘Incident’ must be reported. An ‘Incident’ is defined as:
“Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.”
The following three criteria must be met for an event to constitute an Incident:
- An event has occurred
- The Manufacturer’s device is suspected to be a contributory cause of the incident
- The event led, or might on re-occurence, lead to one of the following outcomes: death or serious deterioration in state of health of a patient, user or other person
Incidents must be reported immediately, without delay that cannot be justified or within the following timelines:
- Public Health Threat: 2 calendar days
- Death or Serious deterioration in health occurred: 10 calendar days
- All other incidents 30 calendar days
Incidents must be reported to the Competent Authority of the country in which the incident occurred.
A ‘Manufacturer’s Incident Report’ form available on the European Commission website1 must be filled in. Details such as manufacturer information, patient/healthcare facility information, description of the incident and timing of follow up must be completed. The Incident Report form may be submitted by either the Manufacturer or the EU Authorised Representative.
You can read the second part of the series where we’ll be answering the most frequently asked questions that we get asked by our clients in relation to medical device vigilance reporting.
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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