How Long Can a Legacy IVD Stay on the Market? The Two Tracks of Art. 110 IVDR

The common table of IVDR transition periods has three rows: class D until the end of 2027, class C until the end of 2028, class B and sterile class A until the end of 2029. It is correct, and for many manufacturers it is still the wrong table. Art. 110 of Regulation (EU) 2017/746 as amended by Regulation (EU) 2024/1860 has two tracks, and the class-based schedule belongs to only one of them. If you hold a certificate under the old directive, you are done on December 31, 2027, in every class.

Track 1: with a legacy certificate, every class ends on December 31, 2027

Art. 110(3a) covers devices with a certificate under Directive 98/79/EC that remains valid under Art. 110(2) IVDR. Placing such devices on the market or putting them into service is permitted until December 31, 2027. The paragraph does not mention a class. A certified class C device has the same last day on this track as a class D device, and so does a certified class B device.

For manufacturers who planned their portfolio by the three-row table, this is the unwelcome news: a class C device with a legacy certificate has no 2028. The table says end of 2028, the regulation says December 31, 2027. The difference points in the direction that hurts.

One special case belongs here: certificates under Annex VI of the directive became void under Art. 110(2) on May 27, 2025, at the latest. Anyone who held only such a certificate is already without Track 1 today.

Track 2: devices that needed no notified body get the staggered schedule

Art. 110(3b) covers devices for which the conformity assessment procedure under Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity under that directive was drawn up before May 26, 2022, and which require a notified body under the IVDR. Only for this group does the schedule by class apply:

• Class D until December 31, 2027 (point a)
• Class C until December 31, 2028 (point b)
• Class B and sterile class A until December 31, 2029 (point c)

This is the largest part of the market, because self-certification was the norm under the directive. So the three-row table is correct for the majority. It becomes wrong as soon as a portfolio contains both tracks and nobody has sorted the devices.

The conditions without which neither track applies

Both tracks apply only if the conditions of Art. 110(3c) are met. Three of them carry no date: the device continues to comply with the directive, there are no significant changes in design and intended purpose, and the device does not present an unacceptable risk. The others depend on calendar dates.

The QMS under Art. 10(8) had to be in place by May 26, 2025, for every group (point d). The application follows the track and the class (point e), and the written agreement with the notified body follows four months later in each case (point f).

The misconception: the extension comes by itself

In projects, the extended deadlines are regularly treated as a given, as if Regulation (EU) 2024/1860 had handed every legacy device one to three extra years. It set conditions, and for most groups the dated ones have passed: the QMS was due on May 26, 2025, as was the application for Track 1 and for class D, and the application for class C on May 26, 2026. The written agreement was due on September 26, 2025, for Track 1 and class D, and on September 26, 2026, for class C. Only for class B and sterile class A are the application (May 26, 2027) and the agreement (September 26, 2027) still open.

A device for which one of these conditions is missing does not have the extended deadline. The regulation offers no consolation at this point, it only says when the extension applies.

If one of the conditions of Art. 110(3c) IVDR is not met, placing the device on the market or putting it into service on the basis of the extended transitional provisions is no longer possible. Further placing on the market is then permitted only with full conformity with the IVDR, including any conformity assessment procedure required (Art. 5 in conjunction with Art. 48 IVDR). Devices already lawfully placed on the market may, as a rule, continue to be made available on the market under Art. 110(4) IVDR.

By May 26, 2027: the application for class B and sterile class A

For class B devices and sterile class A devices on Track 2, May 26, 2027, is the next dated checkpoint in the chain. By that day, the application must have been lodged with the notified body (Art. 110(3c)(e)(iii)). The written agreement follows by September 26, 2027 (Art. 110(3c)(f)(iii)), and placing on the market ends on December 31, 2029.

The class C dates have passed: application on May 26, 2026 (Art. 110(3c)(e)(ii)), written agreement on September 26, 2026 (Art. 110(3c)(f)(ii)). A class C device on Track 2 keeps the end date of December 31, 2028, only if both conditions were met. September 26, 2027, closes the series of dated conditions; after that, only the ends of the transition periods remain.

What already follows the IVDR for legacy devices today

The sentence with the most practical consequences in the article is in Art. 110(3d), and it does not look like a deadline. For devices in the transition period, post-market surveillance, market surveillance, vigilance and the registration of economic operators and devices follow the IVDR, not the directive. At these four points, compliant with the directive means nothing. Anyone who postpones the IVDR obligations until after the new certificate is already behind, and the gap shows up in the notified body's audit at the latest.

Two more paragraphs belong here. Under Art. 110(3e) IVDR, the IVDR notified body that has concluded the written agreement under Art. 110(3c)(f) has been responsible for the appropriate surveillance of the legacy devices covered by that agreement since September 26, 2025, at the latest. Responsibility for the conformity assessment originally carried out under the IVDD does not transfer with it. And under Art. 110(11), the obligation to report an interruption or discontinuation of supply under Art. 10a also applies to devices on both tracks. The EUDAMED deadlines run alongside on their own calendar, see the article on EUDAMED readiness.

Calculated backward

The chain reads from the end. For a class B device on Track 2, placing on the market ends on December 31, 2029; by then the IVDR certificate must be in hand, otherwise placing it on the market stops there. The agreement is due on September 26, 2027, the application on May 26, 2027. The application itself does not yet require finished technical documentation with a performance evaluation, but the conformity assessment that follows does. The time for completing it, for the assessment, for rounds of questions and for audit findings lies between application and certificate and is not provided for in the regulation's calendar. It has to come from your own planning.

In its evaluation of the MDR and IVDR of December 2025, the European Commission gives typical processing times of 13 to 24 months for issuing new certificates with a combined QMS and product assessment (SWD(2025) 1051 final, Section 4.1.1.2). This time span covers both the work of the notified body and the activities required of the manufacturer, and it is not a statutory processing deadline.

For a device on Track 1, the calculation is shorter and harder: end on December 31, 2027, all dated conditions passed. What still counts today are the three undated ones: maintain conformity, no significant changes in design and intended purpose, no unacceptable risk. On this track, a planned further development is a date the manufacturer sets for itself.

What to do now

• Sort the portfolio into two tracks. Which devices hold a certificate under the directive that is still valid, which were placed on the market without a notified body. The calendar follows from the track, not from the class alone.
• Class B and sterile class A: treat May 26, 2027, as a submission date, not as the start of a deadline. The application must meet the requirements of Annex VII Section 4.3 IVDR. Fully completed technical documentation and performance evaluation do not necessarily have to exist when the application is lodged; their timely completion for the subsequent conformity assessment must, however, be planned. The written agreement must be in place by September 26, 2027.
• Class C, Track 2: check whether the application (May 26, 2026) and the agreement (September 26, 2026) are in place. Both deadlines have now passed. If the application and the written agreement were not concluded on time, the device cannot benefit from the extended transition period until December 31, 2028. Further placing on the market then requires full IVDR conformity.
• Freeze changes that would cost the track. Every change to design or intended purpose goes through the assessment of whether it is significant before it is implemented.
• Run PMS, vigilance and registration under the IVDR today, not only after the certificate.

Entourage supports IVD manufacturers in sorting their portfolio under Art. 110, in the deadline roadmap per device, in the application and agreement with the notified body, and in the technical documentation and performance evaluation on which the conformity assessment after the application builds. Most engagements begin with a gap analysis that records for each device which track it is on and which condition of Art. 110(3c) is still open.

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