The European Parliament has decided to postpone the implementation of the Medical Device Regulation (MDR), EU no 2017/745, by one year. Due to the corona crisis, the MDR will now come into effect on May 26, 2021.
This postponement has consequences for Dutch companies active in the medical technology and devices sector. They were largely already ready for the implementation of this regulation. This may include applying for the correct certification. Much is still unclear because individual countries still have to decide how and what will happen with this decision in this extra year.
FME is organizing a webinar on May 26 about the consequences of the postponement of the MDR. This is free for FME members and you can register via the following link. For more information and a FAQ, see the website Ministry of Health, Welfare and Sport. If more information is known, we will also report on it.
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