An active implantable medical device (AIMD) is a “medical device” that relies upon a source of energy (such as electrical) for the functionality of the device and that is intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes, and which is intended to remain in place (as per Regulation (EU) 2017/745). Pacemakers, defibrillators, cochlear implants or neurostimulators are examples of typical AIMDs. The very long development time due to the complexity of the AIMD itself in its intended environment and the supplier management required is the main challenge for AIMD manufacturers.
From 26th of May 2020, the MDR Regulation (EU) 2017/745 shall apply for AIMD and will replace the current EU Directive 90/385/EEC. As AIMDs are considered as high-risk devices because they are designed to remain in direct contact with the body for extended periods, they shall comply to rigorous requirements principally related to electrical safety, electromechanical compatibility (EMC), sterilization, biocompatibility and software to ensure the protection of the health and safety of the patient. EN 45502 is the main reference harmonized standard for AIMD. More other specific standards may apply depending on the intended use of the device.
One of the difficult aspects is to organize V&V and process controls along the various versions of the implantable parts throughout time. Recurrently, the question of the necessity to re-execute testing because of design changes or process changes has to be addressed. Our experts help you to organize the planning and required justifications.
In order to prepare a complete Technical Documentation for the CE marking of your AIMD according to the new Regulation (EU) 2017/745, our AIMD Medidee specialists can help you to define and implement the following: