Active Implantable Medical Devices

Active Implantable Medical Devices BSIAs 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. Directive 90/385/EEC defines the requirements of AIMDs. As an AIMD Notified Body our product specialists can help you navigate the regulatory process to get your product to market.

As an AIMD Notified Body our product specialists can help you navigate the regulatory process to get your product to market.


What is an active implantable medical device?

The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device 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". As one of the highest risk categories of device, they are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the AIMD Directive also apply to any accessories that are used to enable the device to operate as intended, for examples leads, programmers, controllers, battery packs, software applications, implant kits and refill kits. 

As a full scope Notified Body, BSI offers CE certification services to the AIMD Directive. Our AIMD team has a broad range of industry and regulatory experience, including product design and development, manufacture and regulatory expertise. The AIMD team also has specific expertise in radio telecommunications (R&TTE) and software development. 

Examples of AIMDs include:

  • Implantable cardiac pacemakers
  • Implantable defibrillators
  • Leads, electrodes, adaptors for implantable cardiac pacemakers and defibrillators
  • Implantable neuro stimulator systems
  • Brachytherapy
  • Haemodynamic support

  • Cochlear implants
  • Implantable infusion pumps and accessories
  • Implantable glucose monitors
  • Algorithm development
  • Micro Electro-Mechanical Systems (MEMS)
  • Technologies for AIMDs

Why choose BSI for your product compliance to Directive 90/385/EEC?

Used for a wide range of treatments in various specialized fields, Active Implantable Medical Devices (AIMDs) represent a significant and profitable segment of the healthcare industry. And as a manufacturer of AIMDs, one of your biggest challenges in breaking into - or continuing - success in this market – is navigating the regulatory process efficiently.

Our AIMD specialists are not just experienced in the regulatory process, but they are product experts who understand the specifics of active implantable products.

BSI Medical Devices is justifiably proud of its status in the industry as an AIMD Notified Body. Nowhere is this more clearly seen than in our level of experience, our large specialist AIMD team has 11 technical experts, with 12 graduate degrees between them.

BSI Active Implantable Medical Devices graduate degrees

BSI Active Implantable Medical Devices team expertise


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