The European Commission has once again extended the transitional periods for compliance with EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) by Regulation (EU) 2024/1860. This deadline extension offers manufacturers additional time to comply with the extensive requirements of the IVDR. This is intended to prevent potential bottlenecks and ensure security of supply.

The main points summarized

Extended transition periods

Depending on the risk class of the products already CE-marked under IVDD, the transition periods have been adjusted as follows:

• Class D: 31. December 2027
• Class C: 31. December 2028
• Sterile class A devices and class B: 31. December 2029

No extension for Class A (non-sterile) and new IVDs

There is no extended transition period for non-sterile Class A devices and new IVDs that were not certified under the previous directive (IVDD). These devices must already meet the requirements of the IVDR since May 26, 2022.

In-house IVD

In-house IVDs, also known as Laboratory Developed Tests (LDTs), benefit from an extended transition period. From December 31, 2030, healthcare institutions must demonstrate that the specific needs of their target patient population cannot be met by a comparable product on the market or that the available product does not meet the required level of performance. However, they must already meet the essential safety and performance requirements set out in Annex I of the IVDR.

Conditions

However, manufacturers must fulfill certain conditions in order to benefit from the extended transition periods.

Manufacturers must submitt a formal application for conformity assessment to the Notified Body. There are also staggered deadlines for this depending on the risk class

• Class D: Application until 26. May 2025
• Class C: Application until 26. May 2026
• Sterile class A devices und class B: Application until 26. May 2027

A contract must be concluded with the notified body within 4 months of the application in order to benefit from the extended transition period. The plans for Post-Market Surveillance (PMS), Post-Market Performance Follow-Up (PMPF) and Performance Evaluation (PE)  must already be submitted for the application.

Immediate requirements to be observed

Despite the extended transition period, IVD manufacturers must already comply with certain requirements of the IVDR during the transition period. These include obligations in the areas of post-market surveillance (PMS), market surveillance, vigilance and the registration of economic operators and products in EUDAMED.

Quality management system (QMS)

All manufacturers must implement an IVDR-compliant QMS by May 26, 2025 at the latest. The QMS also includes performance evaluation and risk management.

What you should do now

QMS

By May 2025 at the latest, a QMS in accordance with the IVDR is required, including performance assessment and risk management.

Submit formal applications and conclude contracts

Submit formal applications for conformity assessment to the relevant Notified Body within the new deadlines. Secure a written contract with the Notified Body within four months of submitting the application in order to continue marketing the products certified under the IVDD. An accumulation of applications is to be expected towards the end of the deadline, so that a new bottleneck is to be expected.

Use the extended deadlines proactively to ensure the conformity of your products with the IVDR and maintain your presence on the market.

Useful links

• Services by novineon for PMS / PMPF, Performance Evaluation and risk management
• Regulation (EU) 2024/1860
• Q&A of the EU Comission