A US manufacturer CE marks its Class IIa medical device and labels it in multiple languages. If a distributor is contacted from Sweden requesting the product, what should they do?

The correct choice involves notifying the manufacturer and requesting that the label be updated to include Swedish. This approach is important because medical devices must comply with the specific language requirements of the country where they are marketed. In the case of Sweden, it is expected that products intended for consumers or healthcare professionals be labeled in Swedish to ensure proper understanding and safe use.

Compliance with local regulations and standards is a critical aspect of medical device distribution. By contacting the manufacturer for an updated label, the distributor helps ensure that the product adheres to the legal requirements in Sweden, promotes user safety, and mitigates risks associated with misinterpretation of instructions or warnings provided in another language.

The other choices do not align with regulatory expectations. Simply supplying the product as labeled ignores the necessity for local language compliance. Not supplying until a local distributor is appointed could hinder access to the product without addressing label language issues. Translating the label independently poses risks in ensuring the accuracy and regulatory compliance of the new label. Therefore, contacting the manufacturer for proper labeling is the most responsible and compliant action.