Active Implantable Medical Devices

Active Implantable Medical Devices

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Active Implantable Medical Devices
Active Implantable Medical Devices
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Placing your AIMD product on the market

As an AIMD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market.

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.

  • Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Directives and Regulations.
  • Approved Body - BSI UK (0086) - provides conformity assessments under the new UKCA Scheme.

We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

AIMD webinar series

AIMD video series

These insightful videos will help you focus on various aspects of the MDR. From helping you place AIMDs on the market to providing tips for a smooth certification process.

 

MRI position paper

MRI conditionality applications

Our AIMD Team has just released a new position paper incorporating feedback derived from many MR conditional applications for AIMD and other implantable devices. Similar considerations as presented in the paper can be applied to a wide range of device types. 

Download the position paper

What is an AIMD?

According to the MDR an Active Implantable Medical Device is:

  • Its functioning depends on an energy source other than that generated by the human body for that purpose or by gravity, and which acts by changing the density of or converting that energy
  • It is to be totally introduced into the human body or used to replace an epithelial surface or the surface of the eye by clinical intervention and is intended to remain in place after the procedure.
  • It is intended to be partially introduced into the human body by clinical intervention and is intended to remain in place after the procedure for at least 30 days.

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, such as, battery packs, controllers, implant kits, leads, programmers, refill kits, and software applications.

Active Implantable Medical Devices and their accessories are classified as Class III and therefore subject to the most rigorous regulatory controls.

For further clarity and more detailed information on an AIMD, please reference the MDR (EU) 2017/745 for EU and Part III of The Medical Devices Regulations 2002 (as amended) for Great Britain.

THOMAS DOERGE, GLOBAL HEAD OF AIMD, BSI

Meet our expertise

As a manufacturer of AIMDs, one of your biggest challenges in breaking into, or continuing your success in, this market is navigating the regulatory process efficiently. Strong, statistically relevant clinical data demonstrating the safety and performance of your device is essential to ensuring a successful outcome of your MDR application.

Our AIMD Technical and Clinical Specialists have a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise. They will support you through the process of certifying your device.

AIMD brochure

Explore our AIMD brochure

Download our AIMD brochure to learn more about how we can support your product launch.

Download the brochure

Active Implantable Medical Devices under the EU MDR

Thomas Doerge, Global Head Active Implantable Medical Devices at BSI, discusses technical documentation requirements under the EU Medical Device Regulation.