New Medical Device Regulation (MDR) have been published in the Official Journal of the EU on May 5, 2017

The new regulation on Medical Devices (EU) 2017/745 was published on May 5 and will take effect from May 25, 2017. The transitional period will officially start immediately after the entry into force date. The transition from the MDD to the MDR will last 3 years, with 2020 as the application date.

The new regulation can be found on the EUR-lex website:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN

Please contact us for assistance in regulatory strategy and planning with regard to the transition to the MDR.