The Swedish Medicines Agency supervises manufacturers of medical devices and their products on the Swedish market.
The responsibility for medical devices, as well as their manufacture and use, lies with various parties throughout the products’ life cycle.
It is the manufacturer who has the main responsibility to ensure that the products are safe and have the right performance.
The role of the authorities is to conduct review, supervision and market control.
How are incidents handled?
The Swedish Medicines Agency receives reports on, and follows up on, the manufacturer’s investigation of serious incidents and corrective safety measures.
Furthermore, the Swedish Medicines Agency must receive notifications of negative events and incidents from healthcare, dental care, patients and private individuals.
What consequences could there be?
The Swedish Medicines Agency can impose fines and issue market bans.
The National Board of Health and Welfare regulates the use of medical technology products in health care and dental care.