Significant changes ahead for medical device manufacturers
The European Union is currently developing a revised regulation that addresses the requirements for medical devices and active implantable medical devices offered for sale in the EU. Once adopted, the new regulation will replace the EU’s Directive on active implantable medical devices (90/385/EEC) and the EU’s Medical Device Directive (93/42/EEC).
Regulations for Active Implantable Medical Devices (AIMD) under the EU Directive 90/385/EEC
An active implantable medical device (AIMD) is any active medical device 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. AIMDs include a wide range of devices, including pacemakers, defibrillators, infusion pumps, ventricular assist systems and devices, cochlear implants and neurostimulators. Because AIMDs are designed to remain in direct contact with the body for extended periods, they are subject to rigorous standards and requirements to protect the health and safety of patients.
Regulatory requirements for AIMD
Directive 90/385/EEC of the European Union (EU) specifies the Essential Requirements manufacturers and importers must meet to apply the CE Mark and legally market or sell AIMDs in the EU. To demonstrate compliance with the requirements of the AIMD Directive, a manufacturer must develop technical documentation in order to properly evaluate their device. AIMD manufacturers must also establish a quality management system that complies with the Directive’s requirements.
Why choose TÜV SÜD
TÜV SÜD Product Service is the world’s largest EU Notified Body for AIMDs and other medical devices.Our extensive network makes TÜV SÜD Product Service an effective single source for manufacturers seeking expertise in the testing and certification of AIMDs and other medical devices to EU requirements, as well as regulations applicable to medical devices in other major markets.
By achieving compliance with the Essential Requirements of the AIMD Directive, manufacturers may tap into the European market consisting of 500 million consumers. In addition, AIMDs bearing the CE Mark may achieve faster regulatory review and approval in other global markets.
Our services at a glance
- Design dossier and technical documentation review - TÜV SÜD Product Service reviews the technical documentation (design dossier) for the device according to the requirements of the AIMD Directive, and issues after positive assessment the required product certificate.
- Quality system auditing - TÜV SÜD performs a quality system audit consistent with the requirements of the Directive, and issues after positive audit result the required Quality Management System certificate.
- Testing services - TÜV SÜD Product Service provides compliance testing for medical devices in accordance with various relevant regulations and standards. Active implantable medical device testing is based on witness testing on applicant’s premises.
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services required under the EU’s AIMD Directive, including auditing of the manufacturer’s quality system. Active implantable medical device testing is based on witness testing on applicant’s premises.
- Expert partnership - TÜV SÜD Product Service is a trusted partner to companies ranging from global manufacturers to regional and local start-up companies.