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MDR and IVDR: How prepared is your business for the new regulations?

MDR takes effect and IVDR is around the corner - what manufacturers need to know

The European Union’s new Medical Device Regulation (MDR) came into effect on 26 May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) will go into effect one year later. These new directives will bring:

  • Elevated clinical requirements
  • Re-classified and up-classified devices
  • A changing role of notified bodies, leading to bottlenecks and delayed timelines

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 upon implementation of MDR/IVDR.

ICON’s dedicated medical device experts can help you navigate these challenges and prepare your business for success under the new regulations.

To learn more, please contact us.

The IVDR journey

The IVDR journey

A roadmap to meet 2022 deadlines, while navigating pandemic disruptions

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
MDR/IVDR Brings Higher Costs & Bottlenecks

MDR/IVDR brings higher costs and bottlenecks

Is your business strategy in place for a successful transition?

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.

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The key to success under MDR and IVDR

Developing and commercialising medical devices and In-Vitro Diagnostics

The key to success under MDR and IVDR

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
IVDR technical file remediation

IVDR technical file remediation

Understanding technical file requirements for a successful transition

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

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Medical device experience and expertise at ICON

ICON's dedicated team can assist with all phases of your clinical trial development and testing to successfully bring your product to market.

 

Read more about ICON's services in medical devices and diagnostics