Regulation (EU) 2024/1860 of June 13, 2024 amended IVDR Article 110. It entered into force on July 9, 2024, the day it was published in the Official Journal. Its recitals say notified body capacity was still not enough to certify the large number of IVDs that need one, and there was a risk of shortages, especially of Class D devices, when the transitional period then in force ended on May 26, 2025. The amendment changed Article 110(2), replaced Article 110(3) and inserted paragraphs 3a to 3e.
The Deadlines by Class
The table covers two groups. The first is devices with a certificate issued by a notified body under the IVDD (Directive 98/79/EC) that is still valid under Article 110(2). The second is devices that were self-declared under the IVDD, with a declaration of conformity drawn up before May 26, 2022. A device with neither does not fall under Article 110(3a) or (3b) and needs full IVDR conformity before it is newly placed on the market. Under Article 110(4), devices lawfully placed on the market under the IVDD before May 26, 2022, or under Article 110(3) from that date, may continue to be made available.
| Device status | Class | May be placed on the market until | Legal basis |
|---|---|---|---|
| Covered by an IVDD notified body certificate valid under Art. 110(2) | Any class | December 31, 2027 | IVDR Art. 110(3a) |
| Self-declared under the IVDD, notified body now required | D | December 31, 2027 | IVDR Art. 110(3b)(a) |
| Self-declared under the IVDD, notified body now required | C | December 31, 2028 | IVDR Art. 110(3b)(b) |
| Self-declared under the IVDD, notified body now required | B, sterile A | December 31, 2029 | IVDR Art. 110(3b)(c) |
| Self-declared under the IVDD, no notified body needed under the IVDR | A (non-sterile) | Not covered by Art. 110(3b) | IVDR Art. 48(10) |
Every date in the table depends on the conditions in the next section. Article 110(3) grants the derogation only "provided the conditions set out in paragraph 3c of this Article are met".
Two Different Legacy Paths
The class table applies to only one of the two groups. Read a device's path first and its class second.
Path one: certificate-covered (Article 110(3a))
A device with a certificate issued under the IVDD that is still valid under IVDR Article 110(2) follows IVDR Article 110(3a). Its class does not change the date. Every such device may be placed on the market until December 31, 2027, provided the Article 110(3c) conditions are met. Article 110(2) keeps certificates issued from May 25, 2017 valid until that date if they were still valid on May 26, 2022 and have not been withdrawn since.
Path two: self-declared, notified body newly required (Article 110(3b))
IVDR Article 110(3b) covers a device whose IVDD conformity assessment did not involve a notified body, whose declaration of conformity was drawn up before May 26, 2022, and whose IVDR conformity assessment does require a notified body. The class dates apply to this group: December 31, 2027 for Class D, 2028 for Class C, 2029 for Class B and sterile Class A.
So a Class C device with an IVDD certificate ends on December 31, 2027 under path one, and a self-declared Class C device ends on December 31, 2028 under path two. The risk class is the same and the dates are a year apart.
Conditions You Must Meet
IVDR Article 110(3c) lists six conditions. The device must continue to comply with the IVDD, have no significant changes in design and intended purpose, and present no unacceptable risk to health or safety. The other three conditions carry dates.
A quality management system by May 26, 2025
The manufacturer had to put in place a quality management system in accordance with IVDR Article 10(8) no later than May 26, 2025. Point (d) of Article 110(3c) gives this one date for every device, so it does not move with the class dates in the table.
A formal application to a notified body, by group
The manufacturer or the authorised representative must lodge a formal application with a notified body for conformity assessment of the device, or of a device intended to substitute it. Point (e) sets three deadlines: May 26, 2025 for certificate-covered devices and self-declared Class D devices, May 26, 2026 for self-declared Class C devices, and May 26, 2027 for self-declared Class B and sterile Class A devices.
A written agreement with the notified body
Point (f) requires the notified body and the manufacturer to sign a written agreement by September 26, 2025, September 26, 2026 or September 26, 2027, for the same three groups. Each date falls four months after the matching application deadline.
Class A: Sterile vs. Non-Sterile
IVDR Article 48(10) lets manufacturers of Class A devices, other than devices for performance study, declare conformity themselves by issuing the EU declaration of conformity. A non-sterile Class A device needs no notified body under the IVDR, so it does not meet the Article 110(3b) test and the table gives it no extended date.
Sterile Class A devices are different. The same paragraph requires the procedures in Annex IX or Annex XI for a Class A device placed on the market in sterile condition, with the notified body's role limited to the aspects relating to establishing, securing and maintaining sterile conditions. A self-declared sterile Class A device therefore falls under Article 110(3b), point (c), with Class B, and its date is December 31, 2029. Its application deadline is May 26, 2027 and its agreement deadline is September 26, 2027.
Registration vs. Market Placement
Article 110 decides how long a legacy IVD may still be placed on the market or put into service. It does not decide when the device must be registered in EUDAMED. Other provisions do that.
IVDR Article 110(3d) says the IVDR requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply to Article 110(3a) and (3b) devices instead of the IVDD requirements. The registration date comes from IVDR Article 113(3), point (fa), which names devices placed on the market under Article 110(3), (3a) or (3b) and counts from the same Commission notice that starts the MDR registration clock in MDR Article 123(3). That clock is covered in the guide to the November 2026 EUDAMED deadline, and the data for a legacy device without a Basic UDI-DI is covered in the legacy device registration data guide.
A device can be registered in EUDAMED and still be outside its Article 110 window, for example after a missed application deadline. A device inside its Article 110 window can still have a registration duty under Article 113(3), point (fa), if it is also placed on the market from the date in point (f).
Common Mistakes
| Mistake | What Actually Happens | Prevention |
|---|---|---|
| Applying the class table to a certificate-covered device | The device follows Article 110(3a), with one date of December 31, 2027 for every class | Check whether the device holds an IVDD notified body certificate that is valid under Article 110(2) before reading its class off the table |
| Watching only the final 2027 to 2029 date | Article 110(3c) makes the QMS, application and written agreement dates conditions of the extension | Track the QMS, application and agreement dates for each device |
| Assuming Article 110 sets the EUDAMED registration deadline | Article 110 governs market placement; registration timing comes from Article 113(3), point (fa) | Plan the two clocks separately |
| Treating all Class A devices the same | Self-declared sterile Class A devices follow the Class B dates; non-sterile Class A is not covered by Article 110(3b) | Check sterile condition as well as the class letter for every Class A device |
Preparation Checklist
- For each legacy IVD, record whether it is certificate-covered (Article 110(3a)) or self-declared (Article 110(3b))
- For self-declared devices, confirm the IVDR risk class under IVDR Annex VIII to find the right row in the table
- For certificate-covered devices, check that the certificate is valid under Article 110(2), including the July 9, 2024 expiry rule
- Confirm a QMS in accordance with IVDR Article 10(8) was in place by May 26, 2025
- Confirm the formal application to a notified body was lodged by the device's group deadline (May 26, 2025, 2026 or 2027)
- Confirm the written agreement with that notified body was signed by September 26, 2025, 2026 or 2027
- Track EUDAMED registration under Article 113(3), point (fa), as a separate task
The dates above come from IVDR Article 110 as amended by Regulation (EU) 2024/1860. If a legacy IVD in your portfolio is self-declared and its application deadline passed without an application, it cannot use the extended date for its class.
Frequently Asked Questions
What are the IVDR legacy device deadlines by class?
Under IVDR Article 110(3b), as amended by Regulation (EU) 2024/1860, a device that was self-declared under the IVDD and now needs a notified body may be placed on the market until December 31, 2027 for Class D, December 31, 2028 for Class C, and December 31, 2029 for Class B and sterile Class A, if the Article 110(3c) conditions are met. A device with an IVDD notified body certificate that is still valid under Article 110(2) has one date instead, December 31, 2027 under Article 110(3a), whatever its IVDR class.
Is the IVDR deadline the same for every device in a class, or does it depend on whether a notified body was involved under the IVDD?
Yes, it depends on that. Article 110(3a) covers devices with an IVDD notified body certificate that is still valid under Article 110(2). They all get December 31, 2027. Article 110(3b) covers devices that had no notified body under the IVDD, had a declaration of conformity drawn up before May 26, 2022, and need a notified body under the IVDR. They follow the class table. A certificate-covered Class D device and a self-declared Class D device both end on December 31, 2027, under different paragraphs. A self-declared Class B or C device gets a later date than a certificate-covered device of the same class.
Does Class A need to do anything under this transition?
Sterile Class A does. IVDR Article 48(10) lets manufacturers of Class A devices (other than devices for performance study) declare conformity themselves, but a device placed on the market in sterile condition needs a notified body for the aspects relating to establishing, securing and maintaining sterile conditions. Self-declared sterile Class A devices therefore fall under Article 110(3b), point (c), with Class B, and their date is December 31, 2029. Non-sterile Class A devices need no notified body under the IVDR, so Article 110(3b) does not cover them.
What has to happen before a manufacturer can rely on these extended dates?
Article 110(3c) lists six conditions. Three have dates: a quality management system under IVDR Article 10(8) in place by May 26, 2025 for every device; a formal application to a notified body lodged by May 26, 2025 (certificate-covered devices and self-declared Class D), May 26, 2026 (self-declared Class C) or May 26, 2027 (self-declared Class B and sterile Class A); and a written agreement with the notified body signed by September 26, 2025, 2026 or 2027 for the same three groups. The extension applies only if all conditions are met, so a device that misses one of these dates cannot use its later 2027 to 2029 date.
Is the EUDAMED registration deadline the same as these IVDR Article 110 dates?
No. Article 110 decides how long a legacy IVD may be placed on the market or put into service. Article 110(3d) says the IVDR rules on registration of economic operators and devices apply to these devices instead of the IVDD rules, and IVDR Article 113(3), point (fa), sets when that registration is due for those devices that are also placed on the market from the date in its point (f). A device can be inside its Article 110 window and still have a separate EUDAMED registration duty.
What happens to an in-house (health institution) device under this timeline?
A separate rule covers it. Under IVDR Article 5(5), the IVDR's requirements, except the relevant general safety and performance requirements in Annex I, do not apply to devices manufactured and used only within health institutions established in the Union, provided all of a list of conditions are met. Point (d) is one of them: the health institution must justify in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance, by an equivalent device available on the market. Under Article 113(3), point (j), as amended by Regulation (EU) 2024/1860, that point applies from December 31, 2030.