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.
An Active Implantable Medical Device is defined as:
- a device the operation of which 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,
- which 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,
- which is intended to remain in place after the procedure,
- and includes any active device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days.
All 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.
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 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. 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. We are 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 neurostimulator 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)
Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.
