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Medical Device Directive 93/42/EEC

Be confident of medical device market approval

Regulatory requirements for medical devices

From 26 May 2021, the EU Medical Device Regulation, (MDR (EU) 2017/745) has replaced the EU’s Medical Device Directive (93/42/EEC). Devices holding a certificate from a European Notified Body under Medical Device Directive (93/42/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

By complying with the requirements of the EU’s MDR and other regulations that apply to medical devices, manufacturers can tap into the European marketplace which consists of 500 million consumers. 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 medical devices to EU requirements, as well as regulations applicable to these devices in other major medical device markets.

 Our services at a glance

  • Technical documentation review - TÜV SÜD Product Service reviews all documentation for the device according to the requirements of the MDR. 
  • Quality system auditing - TÜV SÜD performs a quality management system audit consistent with the requirements of the MDR. 
  • Testing services - TÜV SÜD Product Service can provide 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 an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range 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. 
  • Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.

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