Regulation (EU) 2017/745 on Medical Devices

DEKRA Certification GmbH is Notified Body for the Regulation (EU) 2017/745 on Medical Devices

On 15 August 2019, DEKRA Certification GmbH received approval as a notified body in accordance with the EU Medical Device Regulation (2017/745, MDR) which came into force on 25 May 2017. After receiving a positive recommendation for approval from the EU body in June, DEKRA was informed of the final decision in August. With this approval, DEKRA Certification GmbH continues to be a reliable, competent partner for its customers in the field of medical device certification and will continue to be able to offer comprehensive services from a single source in the future.

Regulation (EU) 2017/745 on Medical Devices

After more than four years of negotiations at the European level, Regulation (EU) 2017/745 on medical devices came into force on 25 May 2017. With a few exceptions, the Regulation will be valid starting on 26 May 2020, and will replace the two Medical Device Directives 90/385/EEC and 93/42/EEC.

Significant changes include:

  • Specification of the requirements for preparation and maintenance of technical documentation for medical devices,
  • Stricter requirements for clinical evaluation,
  • Introduction of a new category for reusable surgical instruments intended for reprocessing,
  • Introduction of an additional control procedure for high-risk medical devices by a committee of experts (scrutiny procedure),
  • Strengthening of provisions on post-market monitoring of medical devices and the vigilance system,
  • Regulation of the reprocessing of disposable products, including the prohibition of the reprocessing of certain disposable products,
  • Improved product identification and traceability by means of a Unique Device Identification Number (UDI),
  • Obligation of manufacturers to provide liability coverage,
  • Enhancement of transparency through the European database (EUDAMED), which is partly publicly accessible, and
  • New classification rules for software, products with nanomaterials and material medical devices, among others.

Furthermore, the new regulation sets more concrete and stricter requirements for notified bodies in order to achieve uniform designation and monitoring of them throughout Europe. This will have the effect of reducing the total number of notified bodies. DEKRA Certification GmbH is the third notified body in Europe that has been able to fulfil these more stringent requirements and has been notified by the European Commission. The scope of the designation covers both non-active and active medical devices with the exception of active implantable devices. For the exact scope please refer to the official list in the European database NANDO.

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