EU Regulatory Updates

EU Medical Device Regulations come into force and start transition period The Regulation (EU) 745/2017 called the Medical Device Regulation (MDR) and the Regulation (EU) 746/2017 called the

In Vitro Diagnostic Regulation (IVDR) were published in the Official Journal of the European Union in May 2017. At the same time the countdown to the implementation of both of them begins. The requirements of the MDR will come into force between May 2017 and 2020. In the case of the IVDR, the requirements should be implemented between May 2017 and 2022.

The first deadline for coming into force above-mentioned articles from the regulations is 26 November 2017. Subsequently, other articles from the regulations discussing cooperation between member states and the European Commission should be implemented during three-year period for MDR and five-years for IVDR.

Source: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52017AG0002(01)