Notified body
A notified body is an organization that has been authorized by a national or regional authority within the European Union to carry out evaluation and certification of products in various regulated areas.
These bodies have an important role in ensuring that products comply with current rules and standards within their specific sectors. They ensure that products meet the requirements for CE marking and other certification requirements within the EU. In Sweden, for example, the Swedish Medical Products Agency is responsible for notified bodies of medical devices.