Whom should a US based manufacturer inform of an incident involving a Class I medical device sold in Germany?

Whom should a US based manufacturer inform of an incident involving a Class I medical device sold in Germany?

• A. Appropriate authorities outside the EU
• B. CA in Germany
• C. CA in Netherlands
• D. NB

Answer: (C)

A US-based manufacturer must notify the appropriate authority in Germany when an incident involving a Class I medical device occurs. This is because incidents concerning medical devices must be reported to the competent authorities of the country where the device is placed on the market or used. In Germany, this falls under the jurisdiction of the competent authority (CA) responsible for medical devices, which ensures that proper regulations are upheld and that patient safety is maintained. Selecting the CA in Germany aligns with the regulatory requirements set forth by the European Union concerning medical devices, emphasizing the importance of direct communication with local authorities when dealing with incidents. The other options, while related, do not meet the specific requirement of informing the appropriate authority in the country where the incident occurred, which in this case is Germany.

A US-based manufacturer must notify the appropriate authority in Germany when an incident involving a Class I medical device occurs. This is because incidents concerning medical devices must be reported to the competent authorities of the country where the device is placed on the market or used. In Germany, this falls under the jurisdiction of the competent authority (CA) responsible for medical devices, which ensures that proper regulations are upheld and that patient safety is maintained.

Selecting the CA in Germany aligns with the regulatory requirements set forth by the European Union concerning medical devices, emphasizing the importance of direct communication with local authorities when dealing with incidents.

The other options, while related, do not meet the specific requirement of informing the appropriate authority in the country where the incident occurred, which in this case is Germany.