While the Medical Device Regulation (MDR) 2017/745 has become valid after the transition period ended on 26 May 2021, the Medical Device Directive 93/42 (MDD) has finally been replaced by the MDR.
What does this mean for TROGE MEDICAL products?
Taking advantage of the final transition deadline for existing MDD certifications, we are working at full speed to implement all the necessary requirements to apply for CE certification according to MDR.
After formal application for MDR certification at our Notified Body, our current CE certification under MDD will be valid even until the end of 2028. On 20 March 2023, the European Union once again extended the EU MDR transition periods for devices transitioning to the EU MDR. The good news for our distribution partners the EU sell-off date has been fully removed. That means that medical devices you buy from us may continue to be made available on the EU market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.
Currently, it is not known how long our Notified Body will need after the application for product certification according to MDR. Once submitted the certification process will be completely in our Notified Body’s hand and beyond our control. Please rest assured, that our expert Regulatory Affairs team will do their utmost to complete the process within the given deadlines.