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There a huge increase lately by quality managers in the topic of adverse event reporting. This is partly because the new requirements in ISO 13485:2016, Clause 8.2.3 for reporting to regulatory authorities. In addition, the publication of the new European Medical Device Regulations on May 5, 2017 will require all device manufacturers with CE Marking to update their vigilance reporting procedures as well to comply with Articles 87-92.
The good new is that you have time to write your procedures and train your complaint handling unit properly. Most manufacturers are not upgrading their quality system to ISO 13485:2016 until 2018 or 2019. In addition, the some of the new EU regulations are not truly finalized, because the Eudamed database is not even ready for manufacturers to use yet.
What should be in your procedure?
Your procedure should be detailed enough to enable a person that has not submitted a mandatory problem report before to do so. In addition, you may need detailed instructions for importers or distributors of your device–who may be required to submit adverse event reports.
Well-written procedures typically state that you should review and update your risk management documentation when you are investigating complaints–especially when there is a new adverse event to report. That’s not good enough.
You really need your reporting procedure to reference your risk management process and to provide guidance for what information needs to be reviewed and updated. Ideally your risk management documentation should be aligned with reporting requirements so it is obvious which events require reporting and which events should not require reporting.
If you are interested in learning more about writing a reporting procedure, please review the blog I posted today: http://medicaldeviceacademy.com/blog/. The end of the blog also mentions a new training webinar on Canadian Device Licensing that will be live on Wednesday, May 24.
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Ian Hendra My review of adverse event reporting procedures in the US, Canada, the UK, Australia and New Zealand is that they are specified and documented by the regulators in each jurisdiction. There's no need to invent your own.
All you need is a step in the complaints/nonconformity management process that says "Actual or potential death or serious injury? Yes/No" If yes, report it as per the requirements in each jurisdiction. Two caveats: first a neat little table that gives you timelines and URLs, and secondly, some evidence that the person making the call understands the rules. Best idea is to make it a workflow.
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