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 have extensive experience and can support you through the process of bringing your medical device on to the EU market.
An Active Implantable Medical Device is defined as:
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:
Used for a wide range of treatments in various specialized fields, active medical devices represent a significant and profitable segment of the healthcare industry. As a manufacturer of active medical devices, one of your biggest challenges in breaking into – or continuing your success in – this market is navigating the regulatory process efficiently.
Our active medical device specialists are not just experienced in the regulations, they are product experts who understand the specifics of these devices.
BSI Medical Devices is justifiably proud of its status in the industry as a full scope Notified Body, which includes active medical devices. Nowhere is this more apparent than in our level of experience; our specialist Active Medical Devices team has 43 technical experts, 6 clinical specialists supported by a body of internal clinicians, and 10 dedicated support staff.
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.
