New Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR & IVDR) have been published in the Official Journal of the EU on May 5, 2017

The new regulation on Medical Devices (EU) 2017/745 and on In Vitro Diagnostic Medical Devices (EU) 2017/746 were both 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 transition from the MDD to IVDR will be 5 years, with 2022 as the application date.

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

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

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN

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