BSI certifies first AIMD product to the Medical Devices Regulation

Abbott receives BSI AIMD conformity certificate

3 February 2021

BSI today 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 our first to meet the EU Technical Documentation Assessment Certificate, Regulation (EU) 2017/745, Annex IX, Chapter II.

Abbott’s Clinician Programmer app enables clinicians to create customized therapy for neurological conditions, including chronic pain or movement disorders, and the Patient Controller app helps patients manage their prescribed stimulation programs. This certification allows Abbott’s portfolio of neuromodulation devices, including Infinity™ DBS System for patients with Parkinson's disease or disabling tremor, as well as Proclaim™ XR SCS System and Proclaim™ DRG Neurostimulation System for patients living with chronic pain, to be controlled from a tablet or mobile phone. This integration across all Abbott neuromodulation technologies will allow patients to more seamlessly interact with their physicians, enabling enhanced communication and better management.

Paul Risborough, Global Head of AIMD at BSI said: “The assessment included an initial MDR application, audit, software applications, patient kits, and software enhancements. Due to the nature of the product, cybersecurity controls featured heavily in the review. I am proud of the team of 14 people who contributed internally to the review; the team really pulled together to make this happen.”

Gary Slack, Senior Vice-President of the Notified Body at BSI added: “Meeting the requirements for these high-risk devices has been a steep learning curve, especially with many new review forms and many new requirements; as a notified body, we have learnt significant amounts during our early reviews. Our teams are working and learning in parallel to share best practice. This certificate required our dedicated clinical assessors and is the first issue of a clinical evaluation assessment report (CEAR). We are developing our systems and processes to improve our service levels to clients for these rigorous regulatory requirements.”

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