IVDR Transition Timelines Extended

Regulation (EU) 2024/1860 was published on June 9, 2024, in the Official Journal of the European Union (OJEU) with immediate effect. The amending Regulation provides extra time to conduct the conformity assessment of IVD’s needed for a CE certificate or an issued DoC.

This Amending Regulation extends the IVDR transition timelines while also recognizing as valid previously issued IVDD Certificates for the duration of those longer transition timelines. This allows manufacturers to continue placing their devices on the market based on compliance with the Directive and IVDR Art 110 provisions while transitioning them to the IVDR.

However, it is important to note that the extended transition timelines apply only to devices transitioning to the IVDR and meet additional specific conditions in the Regulation. These conditions ensure the manufacturer has taken appropriate steps to transition to the IVDR.

The table below shows the new transition timelines that apply for different IVD classes subject to the following conditions:

• Compliance with Directive 98/79/EC (IVDD) and no unacceptable risk to the health or safety of patients, users, or other persons, or other aspects of public health protection.
• No significant changes were implemented in the design or intended purpose of the device.
• No later than 26 May 2025, the manufacturer has placed an IVDR-compliant QMS.
• No later than the applicable deadlines below, the manufacturer has lodged an IVDR application and has signed a formal written agreement with a Notified Body.

*Conditional to certificates validity (Art 110(2)).

IVD devices covered by IVDD Certificates that were valid as of 26 May 2022, but expired before the publication of this new amending Regulation (dated July 9, 2024) benefit from the extended transition timelines (as shown in the table above) if the manufacturer

• Has applied to an NB and has a signed agreement with an NB before the expiry of the IVDD Certificate, and/or
• Has a granted derogation/exemption issued by a Competent Authority under either Article 54 or Article 92 of the IVDR.

We recommended that manufacturers who have already made or planned their IVDR applications and documentation submissions with an NB do not deviate from their plans.

We strongly recommend manufacturers who are yet to make their IVDR applications to submit them as soon as possible for the following reasons:

• Only those devices transitioning to the IVDR benefit from the longer transition timelines and extended validity of the Directive Certificates for those devices.
• Delaying or changing your current planned submissions will mean that the submissions will be added to the end of the review queue. This has a potential risk of a delayed conformity assessment by an NB.
• Manufacturers cannot change their devices' design or intended purpose under the Directive, even under the longer transition timelines.

Class D IVDs, following the designation of European Reference Labs (EURLs): NB adopted a risk-based Class D transition strategy whereby they actively engage in conformity assessment of high-risk (Class D) devices. Per October 1, 2024, when the designated EURLs are actively operating, NB’s will transition Class D devices into the new framework. The aim is a consistent approach for performance verifications and batch tests on Class D devices.

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