Links - RISE MNB

Medical devices at the Swedish Medical Products Agency

The Swedish Medical Products Agency is responsible for the supervision of medical devices as well as appointing and supervising notified bodies.

NANDO

The European Commission’s database of notified bodies.

Medical Device Regulation 2017/745 (MDR)

The EU’s Medical Device Regulation.

EUDAMED

EUDAMED is the common European database and IT system to be used for the storage and management of data on medical devices, IVDs, products, aesthetic devices as defined in Annex XVI of the MDR, accessories for these devices and their manufacturers.

MDCG endorsed documents and other guidance

Documents issued by the Medical Device Coordination Group (MDCG) to help stakeholders apply EU Regulation 2017/745 (MDR).

Team-NB documents

Documents issued by the European Association for Medical Devices of Notified Bodies (TEAM-NB).