IVDR Transition Update

IVDR Transition
Why was Change Needed
What is changing
How will this impact industry readiness to IVDR
Don’t Delay

In this blog we look at the impact of the recent announcement of the IVDR transition. Abingdon Health’s team has over 20 years’ experience in the lateral flow market and is a knowledge leader in the scale-up, transfer, manufacturing and regulatory approval of lateral flow products across a range of sectors including clinical (self-test, point of care), animal health, plant pathogen and environmental testing

IVDR Transition has been extended 

On the 25 April 2024, the European Parliament unanimously approved the proposal to amend the EU MDR (2017/745) and IVDR (2017/746) regarding the gradual roll out of the Eudamed obligation sighting concern of supply interruption and the transitional arrangements for certain in vitro diagnostic medical devices (IVDs).

The amendment has been requested by industry to ensure continued access to critical diagnostic products, essential for a smooth running European healthcare system, and offering a high level of protection to patients and users of diagnostic tests.

Why was change needed

The IVDR has applied for placing IVDs onto the EU market since 26 May 2022, replacing the existing IVD Directive 98/79/EC, this required that all devices, including legacy devices, must meet a higher level of regulatory compliance. In January 2022, the European Parliament and Council adopted an extension to the transitional arrangement, with extended timelines based on the risk classification of devices:

The original transitional extension was intended to ease the pressure on implementation issues and delay experienced with infrastructure (including Eudamed), Notified Body availability and manufacturing readiness, all of which were impacted by the Covid-19 outbreak.

While the transitions had allowed some breathing space, the industry is facing an uphill struggle to be ready to meet these dates.

What is changing

1. Further transitional extension for some devices

With the exception of legacy devices that do not require conformity assessment (Class A and devices used in Healthcare Institutions), additional time is being added to the transition time for IVDR, and existing devices can continue to be placed on the EU market until the following dates:

To use these timelines however, manufacturers must comply with certain conditions including:

• The devices are CE marked under the IVD Directive,
• There are no significant changes to the design or intended purpose,
• A Quality Management System compliant to IVDR shall be put in place by 26 May 2026,
• A formal application shall be lodged with a notified body 2 years prior to the dates above

2. Bringing forward the mandatory use of  the Eudamed database includes seven electronic elements including UDI, Vigilance and Market Surveillance. The earlier mandatory use of some Eudamed module would offer an enhanced adoption for this critical element of IVDR deployment.
3. Prior notice if supply of an IVD is stopped. To reduce the risk of device shortages, the proposal includes a requirement whereby Manufacturers are required to inform their relevent competent authority and health institutions if there is a temporary, or permanent interruption in the supply of their IVDs, especially if there are few or no alternative products, or where there is a risk of serious harm to patients or public health.

 How will this impact industry readiness to IVDR

The proposal offers a short-term solution for the current state of readiness in the industry for IVDR, especially for Class D devices, which often include low volume, but highly critical diagnostics which were at risk of not meeting IVDR compliance before the deadline of May 2025.

The proposal also encourages an increased usage of Eudamed, which has seen low adoption (caused in part by the delays to each module) by manufacturers within the UDI and Devices module.

In a wider sense, the commission is trying to mitigate the risk of supply shortages as a result of the IVDR transition, although it is currently up to the manufacturer to determine the severity of risk to supply for their products.

Don’t delay

The proposal allows a collective sigh of relief, allowing the industry more time to prepare the technical documentation and engage with a notified body. However, in reality the additional timelines do not offer time to pause. The additional 2-year delay allows the completion of the conformity assessment process, it does not provide any further time for getting the QMS ready for the IVDR.

At Abingdon Health, we have decades of regulatory experience within the IVD and MDR landscape and are available to support your needs in making the transitions as smooth as possible. Contact a member of the team using the contact form below to discuss this subject in confidence.

Note: This blog contains a summary of the key changes within the proposal, it is important that Manufacturers read and understand the proposal in full and get independent legal advice if required.