Share page on LinkedIn

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

On March 20, 2023, Regulation (EU) 2023/607 was published in the Official Journal of the European Union. This new regulation is a targeted amendment of the EU MDR (Regulation EU 2017/745) and the EU IVDR (Regulation  EU 2017/746) which formally extends the MDR transition period, along with other changes, for legacy devices covered by a valid MDD/AIMDD certificate. The new regulation is entered into force immediately. 

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. A perfect storm of complicating factors – including the COVID pandemic, global supply chain disruptions, the limited capacities of notified bodies certified to the new regulations, and the fact that economic operators themselves have been slow to prepare for the transition - have threatened the supply of medical devices and diagnostics to the European market.

For manufacturers with legacy medical devices and diagnostics that have current certificates, but have not yet completed the MDR or IVDR certification process, extension of the transition period provides welcome relief, but conditions apply. ICON’s dedicated medical device experts have proven experience with supporting companies in successful transitions to the EU MDR and EU IVDR, and are intimately knowledgeable about the targeted amendment. To learn more, please contact us.

EU MDR and IVDR transition extension: What changes do you need to know about?

EU MDR and IVDR transition extension: What changes do you need to know about?

Read this briefing document to understand the MDR amendment, including transition period extension and conditions and the current status of IVDR.

Read more
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.

Read the whitepaper
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

Latest on Regulatory Intelligence

If you would like to receive our regulatory email updates, including the latest on regulatory information please visit our Preference Centre webpage and select Regulatory Updates under Value Based Development.

Receive Regulatory Intelligence email updates

EU Regulations and MDR/IVDR blogs

EU Regulations and MDR/IVDR media contributions from ICON experts

EU Regulations on-demand webinar recordings

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