Active Implantable Medical Devices

Justifiably proud of our status as a full scope AIMD Notified Body

AIMD Active Implantable Medical Device BSI

As one of the highest risk categories of device, active implantable medical devices (AIMDs) are subject to rigorous regulatory controls before they can reach global markets.

The Medical Device Regulation (MDR) (EU) 2017/745 defines the requirements of these medical devices. As an AIMD Notified Body our technical specialists can help you navigate the regulatory process to bring your device on to the EU market.

What is an AIMD?

An AIMD is defined as "any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.”

AIMDs are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the MDR also apply to any accessories that are used to enable the device to operate as intended, for example: battery packs, controllers, implant kits, leads, programmers, refill kits, and software applications.

BSI is the only organization with two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797); both of which have full scope designations to the IVDR and MDR. Our AIMD team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise, and is able to offer CE certification services for AIMDs under the MDR. Examples of products we cover include:

  • Implantable cardiac pacemakers and accessories
  • Implantable defibrillators and accessories
  • Implantable neuro stimulator systems and accessories
  • Leads, electrodes, adaptors for implantable pulse generators
  • Brachytherapy systems and accessories
  • Ventricular Assist Devices (VADs) and accessories
  • Cochlear implants and accessories
  • Implantable infusion pumps and accessories
  • Implantable glucose monitors and accessories
  • Micro Electro-Mechanical Systems (MEMS)

Stay up to date with the latest updates from BSI