Who should a US-based manufacturer inform if an incident is reported in Japan regarding a Class I medical device they produce?

In the context of the US-based manufacturer reporting an incident regarding a Class I medical device in Japan, the correct action would be to inform the appropriate authorities in Japan regarding the incident. However, this question specifically zeroes in on the European context as it provides the choices focused on the EU's regulatory framework.

The correct answer reflects the importance of ensuring that any relevant regulatory authority is informed about the incident, which in this case is centered around the medical device's compliance and safety within a specific jurisdiction. Given that Class I medical devices are generally lower-risk products, the manufacturer must communicate with the applicable Competent Authority (CA) in Japan if the incident has implications for a broader market, including discussions with authorities that might have oversight or consensus in international markets, particularly in Europe.

Choosing the Competent Authority in the Netherlands highlights the relevance in a broader European regulatory context. It aligns with the obligations manufacturers have under the Medical Device Regulation (MDR) and their attention to vigilance and reporting as required for the safety of devices.

It's essential to note that reporting to the CA in Germany or engaging with a Notified Body (NB) may not directly relate to incidents reported specifically in Japan, as the manufacturer's first responsibility lies within the jurisdiction where the incident was reported and