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

MDR and IVDR transition periods for legacy products – what manufacturers need to know

The European Union’s Medical Device Regulation (MDR) came into effect on 26 May 2021 followed by the In Vitro Diagnostic Device Regulation (IVDR) the following year (26 May 2022). These new regulations brought with them elevated clinical requirements, re-classified and up-classified devices, and a changing role for notified bodies, resulting in a certification bottleneck. 

The European Commission has issued a proposal to extend the MDR transition period, and other changes, for legacy devices covered by a valid MDD/AIMDD certificate.  This action follows the adoption of the extension of the IVDR transition period in 2021. For manufacturers with legacy devices that have current certificates, but have not yet completed the MDR or IVDR certification process, extension of the transition period may buy you some much needed time but conditions apply.

ICON’s dedicated medical device experts have proven experience with supporting companies in successful transitions to MDR and IVDR. 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.

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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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Early planning: 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.

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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.

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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.


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