Be confident of medical device market approval
Active implantable medical devices (AIMD) 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.
From 26 May 2021, the EU Medical Device Regulation, (MDR (EU) 2017/745) has replaced the EU Directive on Active Implantable Medical Devices (90/385/EEC). Devices holding a certificate from a European Notified Body under the Active Implantable Medical Devices Directive (90/385/EEC) have an additional grace period and may continue to be placed on the market until 26 May 2024 if the manufacturer fulfil the specific prerequisite requirements drawn in the MDR.
Click here for more information about the Medical Device Regulation.
TÜV SÜD Product Service is one of the largest EU Notified Body for medical devices covered by MDR. 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 MDR, manufacturers may tap into the European market consisting of 500 million consumers.
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