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Certification according to MDR (EU) 2017/745

DEKRA is a Notified Body for Regulation (EU) 2017/745 on medical devices

After more than four years of negotiations at European level, Regulation (EU) 2017/745 on medical devices came into force on May 25, 2017. With a few exceptions, the regulation will apply from May 26, 2020 and replaces the two medical device directives 90/385/EEC and 93/42/EEC.

On August 15, 2019, DEKRA Certification GmbH received notification as a notified body in accordance with the EU Medical Device Regulation ((EU) 2017/745, MDR), which came into force on May 25, 2017. After receiving a positive recommendation for approval from the EU body in June, the final decision was made in August.
The main new features of MDR (EU) 2017/745 include
  • Specification of the requirements for the creation and maintenance of technical documentation for medical devices,
  • Tightening of the requirements for clinical evaluation,
  • Introduction of a new group of reusable surgical instruments intended for reprocessing
  • Introduction of an additional control procedure for high-risk medical devices by a panel of experts (so-called scrutiny procedure),
  • Tightening of the provisions on post-market surveillance of medical devices and the vigilance system,
  • Regulation of the reprocessing of single-use devices, including a ban on the reprocessing of certain single-use devices,
  • Improving the identification and traceability of devices by introducing a unique device identification number (UDI),
  • Obligation of manufacturers to provide cover in the event of liability,
  • Increased transparency through the European database (EUDAMED), which is partially accessible to the public,
  • New classification rules for software, products with nanomaterials and material medical devices, among others.
Furthermore, the new regulation also pursues the goal of uniform designation and monitoring of notified bodies throughout Europe on the basis of more specific and stricter requirements. This will lead to a further reduction in the number of Notified Bodies in this area. DEKRA Certification GmbH is the third Notified Body in Europe that has been able to fully demonstrate the stricter requirements and has been notified by the European Commission. The scope of the notification covers non-active and active medical devices with the exception of active implantable devices. For the exact scope of application, please refer to the official list in the European database NANDO by following the link on this page.
Further information