The European Union’s new Medical Device Regulation (MDR) will go into effect in May of 2021, and In Vitro Diagnostic Device Regulation (IVDR) will go into effect one year later. These new directives will bring:
Collectively, these requirements will have a profound impact on the business models of medical device and diagnostic companies around the world. For manufacturers wanting to gain a competitive edge in the market, they must have the right business strategy in place prior to the implementation of MDR/IVDR.
ICON’s dedicated medical device experts can help you navigate these challenges and prepare your business for success under the rapidly approaching regulations.
To learn more, please contact us.
The IVDR, alongside the Medical Device Regulation (MDR), provides a harmonised regulatory framework to ensure the safety and performance of devices. Major impacts of the IVDR include greater transparency, extended scope, increased oversight, heightened traceability, stricter requirements, as well as analytical performance and scientific validity.
In this whitepaper, we lay the groundwork for a successful transition.Read the whitepaper
The new EU medical device regulations (MDR) and in vitro diagnostic device regulations (IVDR) will begin going into effect in just a few months, at the start of 2020. As a result, some under-prepared manufacturers will be forced to pull some or all of their products off the EU market, while others will face significant delays.Read the whitepaper
Read the "Getting Ready for Europe’s New Rules: A Guide for Successfully Developing and Commercialising Medical Devices and In-Vitro Diagnostics under MDR and IVDR" white paper to learn how to effectively prepare for these imminent regulatory changes.Read the whitepaper
The new In Vitro Diagnostics Regulation (IVDR) requirements impact the entire IVD lifecycle. As a result, manufacturers may be experiencing significant increases in workloads across the medical device and diagnostic value chain. Discover the key elements of a successful IVDR techical file remediation strategy in this factshet.Read the factsheet