Anon,
In still waiting patiently for some guidance replacing/updating MEDDEV 2.12/1 it is generally still the guidance document to use for reporting serious incidents and Field Safety Corrective Actions (FSCA).
1. If the serious incident occurs outside of the European Union there is no requirement to report this incident to a Member State - even if the product is CE Marked and sold in the European Union.
2. If a field corrective action (or maybe A corrective action) is taking place in a country outside of the European Union for which a product is sold in the EU, CE Marked, then this needs to be notified to the Competent Authority (CA) of your Authorised Representative (AR). There is not a need to notify any other CA unless a FSCA is also being done in that Member State.
In the future, once EUDAMED is fully implemented, this will be easier because there will be a single portal where serious incidents and FSCA/FSN are entered in the electronic system. This hopefully will remove any issues about reporting to various agencies as this will be kept in the Vigilance module of EUDAMED so individual Member State reporting will not need to be performed.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Sep-2022 21:37
From: Anne LeBlanc
Subject: FSCA and Incident Reporting (MIR)
Hello Anon
Guidance document MEDDEV 2.12-1 might be helpful. It says incidents need to be reported to the CA of the state where they occurred, and FSCAs need to be reported to all the affected states as well as the AR's state.
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Anne LeBlanc
United States
Original Message:
Sent: 12-Sep-2022 00:35
From: Anonymous Member
Subject: FSCA and Incident Reporting (MIR)
This message was posted by a user wishing to remain anonymous
Dear Experts,
I need your help to understand a few aspects of EU incident reporting and FSCA.
1. Incident Reporting (MIR) -
If a Death or Serious Incident occurred in Japan, do I need to inform the Competent Authority (CA) of the EU Member States? If yes, then how to determine which member state?
Note: we have our AR (Authorized Representative) in Germany.
2. FSCA -
The same question, if the serious incident led us to take corrective action, do we need to inform about FSCA to all the CA in the EU?
I have read that EU MDR says, we need to inform the CA of the member state where our AR is located. But what about other CA?
Thanks in advance