Active Implantable Medical Devices
Active implantable medical devices (AIMD) are used for a wide range of treatment in the health care industry. The term AIMD was initially defined in the Directive 90/385/EEC. The article 1(C) of this directive refers to an active implantable medical device as an 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.
Progress of bioelectronics, biomaterials and biotechnology during the recent decades provided more opportunities to development and advancement of implantable medical devices which have a significant effect on improving patient’s quality of life. However AIMDs are considered as one of the highest risk medical device categories due to the fact that they are totally or partially implanted into the body and that they are functioning on a source of energy (electrical energy or any source of power other than that directly generated by the human body or gravity). The conformity assessment process of these high-risk devices is consequently very rigorous and request a high level of assessment by Notified Bodies.
Although AIMD is covered under its own Directive (90/385/EEC), this category of medical devices is now included under Regulation (EU) 2017/745. The new European Medical Devices Regulation (EU) replaces both Active Implantable Medical Devices Directive (90/385/EEC) and Medical Devices Directive (93/42/EEC). Under the new regulations, AIMD are subject to similar requirements as Class III devices.
Article 8 of the Regulation (EU) 2017/745 and Article 5(1) of the Directive 90/385/EEC support the use of harmonized standards (published in the Official Journal of the European Union) to demonstrate the conformity with the requirements of respective Regulations and AIMD directive covered by those standards
General requirements for active implantable medical devices are historically addressed in the harmonized standard EN 45502-1. For some specific types of AIMDs, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this general standard. The family of EN 60601-1 standards are also applicable to the active non implantable parts of these devices. This family of standards along with others are largely used by manufacturers as part of conformity assessment related to AIMD directive.
GMED teams include highly qualified experts to assess in particular:
- Implantable cardiac pacemakers,
- Implantable defibrillators,
- Implantable defibrillators,
- Leads, electrodes, adaptors for implantable cardiac pacemakers, defibrillators, neurostimulators,
- And many other active implantable medical devices.
Our teams of experts, dedicated to the health care and medical devices industry, and our proven practices make GMED among the leading companies at an international level.
GMED is a well-known notified body thanks to its experience and state of the art knowledge of all types of medical devices including high-risk and innovative devices.