August 2018 White Paper 4 ways the Medical Device Regulation will impact your device studies Author: Matthias Havenaar4 ways the Medical Device Regulation will impact your device studies 2 Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As of May 25th 2017 the Medical Device Regulation (MDR) has replaced the long standing Medical Device Directive (MDD). The impact of the MDR to the medical device industry is substantial. Markedly, the new regulation will require a re-registration and re-classification of all medical devices currently on the market. Companies are given until May 26th 2020 to meet the new regulations. Current CE registered products are given until 2024 to re-register under the MDR. What do

Join for free to read