BSI (British Standards Institution) has announced that it has certified its first Active Implantable Medical Device (AIMD) products, Abbott’s neuromodulation clinician programmer app and its patient controller app for use on compatible personal Apple smartphone devices, to the Medical Devices Regulation (MDR) (EU 2017/745) via its Notified Body in The Netherlands (2797).
All Active Implantable Medical Devices and their accessories are classified as Class III and subject to the most rigorous regulatory controls. The BSI certificate is the first to meet the EU Technical Documentation Assessment Certificate, Regulation (EU) 2017/745, Annex IX, Chapter II.
