Active Implantable Medical Devices

Active Implantable Medical Devices

Red Overlay
Active Implantable Medical Devices
Active Implantable Medical Devices
Red Overlay

Justifiably proud of our status as a full scope AIMD EU Notified Body and UK Approved Body

As a manufacturer of an active implantable medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the Medical Device Regulation (MDR) (EU) 2017/745 and, for Great Britain, the Part III of The Medical Devices Regulations 2002 (as amended).

It is critical to work with an EU notified body or UK approved body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, reliably and promptly. Our technical specialists have extensive experience in AIMD medical devices and can support you through the process of certifying your device.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.





Additional AIMD Resources