On March 7th, 2017 the Council of the European Union voted their approval of the new Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). This is a significant step forward that many have looked forward to, and the new regulations are expected to improve the safety of medical devices in the European Union. It should be noted that both laws have one more step to go, which is the final adoption by the EU Parliament, expected to occur in April.
Click here to read the official Press Release for additional details. We will provide additional updates as developments occur.
UL Regulatory Consultants are ready to help you understand the impact of and changes to the MDR and IVDR. Click here to find realated articles, webinar recordings and other resources.