Representing one of the largest medical device markets in the world, the European Union (EU) recently underwent a significant regulatory shift. In 2016, the EU Council, Parliament and Commission agreed on final regulatory texts that will govern medical devices and in vitro
diagnostic medical devices (IVD), reportedly beginning in 2020. The proposed regulations, the Medical Devices Regulation (MDR) and the in vitro
Diagnostic Medical Devices Regulation (IVDR), are designed to fill the regulatory gaps uncovered as technology outpaced the current regulatory regime, which was last updated in 2007. This new regulatory order, reportedly scheduled to be published in the Official Journal of the European Union
in the spring of 2017 and to become fully effective three to five years later, ushers in a new regulatory era for medical device and IVD manufacturers throughout the world.
This publication is the second in a series of three that examines the new EU regulations governing Medical Devices and in vitro Diagnostic Medical Devices. Focusing on the MDR, this publication will examine it and focus on the medical device-specific provisions therein regarding classification, clinical evaluations and data, and conformity assessments. Specifically, we will cover:
- Medical device classification, including a general explanation of the classification rules
- Clinical investigation and clinical evaluation requirements for medical devices
- Medical device-specific conformity assessments and an explanation of each route
For reference, please follow this link to Part 1 on our website..