Project design for the implementation of the Medical Device Regulation (MDR)
The new Medical Devise Regulation (MDR), which came into force on 17 May 2017, poses considerable challenges for medical device manufacturers and the pharmaceutical industry. The new regulation deeply intervenes in the complex development processes and also applies to established market products. As a result, in addition to the time-consuming conversion processes, delays resulting from necessary tests and the involvement of Notified Bodies must also be taken into account. In order to meet the implementation deadline of 26 May 2020, an early and professional project design is essential.
Compliance and implementation of the requirements of MDR by May 2020