Two new regulations fundamentally change the way medical devices are regulated in the EU.
Join Jay at the MDR & IVDR EU Conference, December 4-6 in Orlando, Florida!
On 5 April 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations were published in the Official Journal of the European Union – the last step in their long and arduous journey. The MDR applies from 26 May 2020 and the IVDR applies from 26 May 2022. These new regulations were developed because “… a fundamental revision of those Directives [on medical devices, active implantable medical devices, and in vitro diagnostic medical devices] is needed to establish a robust, transparent, predictable and sustainable regulatory framework … which ensures a high level of safety and health whilst supporting innovation (Recital 1).”
The two new regulations fundamentally change the way medical devices are regulated in the EU – and impose significant new responsibilities on all economic operators. These regulations “…set high standards of quality and safety … in order to meet common safety concerns as regards such products (Recital 2).” Among the many changes that the MDR and IVDR introduce, they up-classify many device types; regulate as devices products that were not previously regulated; introduce an EU UDI System; enhance a manufacturer’s Quality System requirements; introduce new requirements for clinical evaluation; impose significant new requirements related to post market surveillance; and drastically change the relationships and review processes involving manufacturers, Notified Bodies, and Competent Authorities. This will all affect the conformity assessment of devices being brought to market in the EU.
Though there are many questions yet to be answered about how the MDR/IVDR will actually work, many guidance documents still in development, and ambiguity around the new Eudamed, manufacturers cannot afford to delay implementation. There are too many changes affecting too many processes to wait until everything is defined and well understood. To that end, USDM is proud to be the primary sponsor of the MDR & IVDR EU Conference 2017, being held 4-6 December in Orlando, FL. We are hosting a pre-conference workshop on Monday, December 4 focused on developing and maintaining the product identification and device master data needed to meet the needs and challenges of the evolving global regulatory and commercial landscape. I hope to see you in sunny Florida!
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*This blog was written prior to the European Commision MDR/IVDR deadline delays. Click here for the most recent updates.
About the Author
Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.
About USDM Life Sciences
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.
Vice President of Unique Device Identification Solutions Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.