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

The correct choice indicates that the distributor should notify the manufacturer and request the label be changed to include Swedish. This is important because regulatory compliance in the EU is stringent, and labeling must be in the official language of the country where the product is being marketed or sold.

In this case, while English may be widely understood in Sweden, the regulations mandate that medical device labeling must be accessible and clear to users and patients, ensuring their comprehension of product instructions, especially regarding safety and usage. Therefore, having Swedish language on the label is essential for compliance with local laws, ensuring that the manufacturer meets the requirements for commercialization within that market.

Moreover, addressing the translation of labels reinforces the company's commitment to patient safety and regulatory adherence, which is crucial for maintaining brand reputation and avoiding potential legal issues.