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Active Implantable Medical Devices

Be confident of medical device market approval

Regulations for Active Implantable Medical Devices

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.

Regulatory requirements for AIMD

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.

Why choose TÜV SÜD

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.

Our services at a glance

  • Technical documentation review - TÜV SÜD Product Service reviews the technical documentation for the device according to the requirements of the MDR. 
  • Quality system auditing - TÜV SÜD performs a quality system audit consistent with the requirements of the MDR.
  • Testing services - TÜV SÜD Product Service provides compliance testing for medical devices in accordance with various relevant regulations and standards.

 Your benefits at a glance

  • Recognised medical device expertise - TÜV SÜD Product Service is one of the largest EU Notified Body in the world. 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 Medical Device Regulation, including auditing of the manufacturer’s quality system. 
  • Expert partnership - TÜV SÜD Product Service is a trusted partner to companies ranging from global manufacturers to regional and local start-up companies.

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