EU IVDD to IVDR Transition under Article 110

1. Key takeaways

The IVDD (Directive 98/79/EC) was repealed under Article 112 as from 26 May 2022, but Article 110 preserves a transition corridor for legacy devices: devices placed on the market before 26 May 2022 under the IVDD that require notified body involvement under the IVDR may continue to be placed on the market during a defined period, provided the conditions are met. That transitional framework has been amended three times, by Regulation (EU) 2022/112 (adopted 25 January 2022), Regulation (EU) 2023/607 (adopted 15 March 2023) and Regulation (EU) 2024/1860 (adopted 13 June 2024, entered into force 9 July 2024).

The corridor is conditional, not automatic, and it does not suspend compliance duties. Post-market surveillance, market surveillance and vigilance obligations under the IVDR already bind legacy devices, and the conditions for using the extension, including deadlines for quality management systems, application submissions and written agreements with notified bodies, are staggered by class. Every conclusion below rests on the amended text of Article 110 rather than on the original 2017 wording.

2. Legal basis

The table below lists the instruments that shape the IVDD-to-IVDR transition.

Because the three amending regulations build on each other, citations should always point to the consolidated text of Article 110 as amended by Regulation (EU) 2024/1860, with the earlier amendments recorded in the file history.

3. Expert insights

Insight 1: the transition corridor targets devices that need a notified body for the first time under the IVDR.

The European Commission’s question-and-answer document frames the scope as follows: it applies to devices for which a conformity declaration was drawn up under the IVDD before 26 May 2022 and for which conformity assessment under the IVDR requires notified body involvement, unlike under the IVDD. Devices already certified by a notified body under the IVDD, a small fraction of the installed base, follow a separate certificate-extension path. The two paths differ in both their conditions and their end points, so the first analytical step for any legacy portfolio is to sort device entries into the two paths before reading any deadlines.

Insight 2: the transition is not a pause in compliance, only a deferral of conformity assessment.

According to MDCG 2022-8, the Chapter VII obligations of the IVDR, covering post-market surveillance, market surveillance and vigilance, apply to legacy devices in full. Manufacturers must operate a post-market surveillance system based on a PMS plan (Articles 78 and 79) and must apply the post-market performance follow-up requirements of Annex XIII Part B (PMPF). In practice, compliance gaps among legacy portfolios appear most often in the PMS system rather than in the technical documentation, precisely because teams assume that the old IVDD file remains sufficient until the IVDR assessment begins.

Insight 3: the three amendments move in the direction of longer periods, class-based segmentation and removal of the sell-off deadline.

Regulation (EU) 2022/112 first introduced transition periods segmented by class. Regulation (EU) 2023/607 deleted the sell-off provision, so devices lawfully placed on the market during the transition may continue to be made available until the certificate or shelf life expires. Regulation (EU) 2024/1860 extended the class-based periods further, added the supply-interruption notification duty in Article 10a, and rewrote the mechanism by which EUDAMED modules are rolled out. The cumulative deadlines that result from all three amendments are set out in part 06 of this series.

Insight 4: transition eligibility is continuously conditional, never permanently acquired.

Under the Commission’s question-and-answer document, legacy devices must continue to conform to the original directive, must not undergo significant changes in design or intended purpose, must not present an unacceptable risk to patients or public health, and must satisfy the time-point requirements for the quality management system, the application and the written agreement. If any condition fails at any time, the transitional period ends at that moment. Eligibility is therefore a standing state that change control, quality management and regulatory teams must monitor together, not a status granted once at the start.

4. Practical recommendations

1. Draw up a decision table per device entry recording whether transition eligibility has been established, citing the basis that the device was placed on the market before 26 May 2022.
2. Stand up the PMS and vigilance system to the standard of Chapter VII of the IVDR now, because those obligations apply during the transition itself.
3. Embed transition-eligibility conditions into the change control process: any design or intended-purpose change must first undergo a significant-change assessment.
4. Fix the eligibility evidence with the written agreement and the proof of application submission, so that the position can be demonstrated years later.
5. For products without transition eligibility, such as newly launched models, go straight down the full IVDR route and do not spend time on transitional arguments that will not apply.

5. Verification checklist

• □ Confirmed that the product was lawfully placed on the market under the IVDD before 26 May 2022
• □ Confirmed whether the product requires notified body involvement under the IVDR (which decides the applicable transition path)
• □ Obtained and preserved the evidence of application submission and of the written agreement
• □ PMS and vigilance system established in line with Chapter VII
• □ A significant-change assessment node embedded in the change control process
• □ Tracked whether Article 110 is amended again by later amending regulations

Regulatory information verified as of 29 October 2026.

GRZAN maps legacy portfolios against the amended Article 110, determines which transition path applies to each device entry, and builds the PMS and change-control structures that keep transitional eligibility alive until IVDR certification is complete. For tailored compliance support on the EU IVDR market, contact info@grzanglobal.com.