CMC


How to report serious incidents o


All you need to know about the reporting can be found in Article 87 for MDR and 82 for IVDR. Including the requirements and the Field Safety Corrective Actions (FSCA).

With the new regulation, manufacturer should report the following:

1)    Any incident that, is not documented in the product instruction or information or does not appear in the Technical File of the product, should be reported by a trend reporting.

2)    Any Field Safety Corrective Action (FSCA) for devices in the EU.

There are 3 different timeframes to determine the trend reporting, depending on the severity of serious incident of your product (both MDR and IDVR), you could have 2, 10 or 15 days to complete the trend report.

Eudamed system should be used when reporting to the Competent Authorities, manufacturer and member states should analyze all datas.

The manufacturer should present a solution or how to manage in case of incidents, how to determine the severity of the incident and should include the observation period in the post-market surveillance plan.

For incidents that are not serious, the manufacturer should report the electronic system.

All these datas should be prepared to be revised by the Competent Authorities and in case they ask for solution, the Competent Authorities should inform the Commission and the Notified Body who issued the certificate about the result of the revision and the solution adopted