Aktive implantierbare Medizinprodukte durch BSI

Active Implantable Medical Devices BSIActive Implantable Medical Devices (AIMDs) are subject to strict standards and definitions before they can reach global markets. Directive 90/385/EEC regulates the market readiness and service parameters for AIMDs.

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?

AIMDs are typically high risk devices and are subject to rigorous standards and definitions before they can reach global markets. Directive 90/385/EEC regulates the market readiness and service parameters for active implantable medical devices (AIMDs). In order to meet regulations under 90/385/EEC, a product must meet the directive’s definition of an AIMD: a medical device that is – at the same time – both “active” and “implantable”.

Quote from the directive “Active implantable medical device" means 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.”

This definition may apply to an entire system or to interchangeable parts intended to form a system (together along with other devices). In these cases, each part belonging to a system is covered under the Directive – regardless of whether such part on its own is 'active', 'active and implantable' or not.

Examples of AIMDs include:

  • Active medical devices
  • Implantable cardiac pacemakers
  • Implantable defibrillators
  • Leads, electrodes, adaptors for implantable cardiac pacemakers and defibrillators
  • Implantable nerve stimulators
  • Bladder stimulators
  • Sphincter stimulators
  • Diaphragm stimulators

  • Cochlear implants
  • Implantable active drug administration device
  • Catheters, sensors for implantable active drug administration device
  • Implantable active monitoring devices
  • Programmers, software, transmitter accessories to a device that is active and implantable

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 justifiable 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 9 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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