- Telefon: +49 711 7861-3771
- E-Mail: email@example.com
- Anschrift: Handwerkstraße 15, 70565 Stuttgart
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.
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:
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.