In 2024, the European Commission published guidance on the extended transition period for the In Vitro Diagnostic Medical Devices Regulation (IVDR) and updated guidance on the Medical Devices Regulation (MDR) transition. Regulation (EU) 2024/1860 prompted questions about which legacy devices could qualify and what manufacturers needed to document. This article summarizes the guidance as it stood in 2024; manufacturers should check the current official texts and their device-specific circumstances before relying on any transition route.

IVDR Transition: Which Devices Were Covered?

The extension concerned qualifying legacy in vitro diagnostic devices, not a general grace period for newly introduced products. A device’s status under the earlier IVDD, its certificate or declaration of conformity where applicable, and compliance with the extension conditions all mattered.

The 2024 guidance described staged deadlines tied to risk class. It identified May 26, 2025 for an IVDR-compliant quality management system and for class D manufacturers to submit a notified-body application; other application and agreement deadlines for class C, class B and class A sterile devices followed on different dates. These milestones have since passed or may be approaching depending on the class. Check the applicable date, evidence and conditions for the specific device in the current official guidance.

What if a Manufacturer Was Not Seeking IVDR Certification?

When this guidance was published, some qualifying legacy devices could continue to be placed on the market during an initial period under the transitional provisions, even before the later application milestones. That did not remove relevant IVDR obligations such as post-market surveillance, vigilance and registration. The 2024 article discussed May 26, 2025 as a key quality-management milestone. It should not be read as a present-day blanket permission to continue marketing an IVDD device.

How Could a Manufacturer Demonstrate Eligibility?

Customers, distributors or customs brokers may ask for evidence that a device satisfies the transition conditions. Depending on the device and stage of the process, the guidance discussed several forms of documentation:

1. Manufacturer statement: identify the devices concerned, applicable IVDD certificates and how the conditions and deadlines have been met.
2. Notified-body application and written agreement: retain records of the submission and the agreement where required.
3. Notified-body confirmation: a letter may confirm receipt of an application and the status of the written agreement.
4. Certificate of Free Sale: where issued by a competent authority, its stated validity depends on the device’s qualifying status and supporting documentation.

In 2024, the article noted that templates and practices for confirmation letters were still evolving. Rather than treating a template or a certificate as automatic proof, check which evidence the relevant authority or trading partner currently accepts.

What About Changes to a Legacy Device?

Administrative changes, such as an address update or a change of authorised representative, are different from significant changes to design or intended purpose. The latter can affect whether a device remains eligible for transition. The article referred to MDCG 2022-6 for guidance on distinguishing significant from non-significant changes; a manufacturer should document its assessment for the device concerned.

Do Legacy Devices Need IVDR UDI Assignment?

The 2024 guidance distinguished legacy devices under the transitional provisions from devices CE-marked under the IVDR when discussing unique device identification (UDI). The original discussion stated that IVDR UDI assignment requirements did not apply to the former in the same way as to IVDR-certified devices, even where quality-management obligations applied. Check the current guidance for related registration and traceability obligations rather than treating this as a general exemption from identification duties.

Related MDR Transition Questions

The updated MDR Q&A discussed how Article 10(9) quality-management requirements apply to legacy devices, taking into account that they are not yet fully MDR-compliant. It also addressed arrangements for transferring appropriate surveillance from a notified body that issued an MDD or AIMDD certificate to an MDR notified body. Self-declared devices under the MDD that newly require notified-body involvement under the MDR have a different surveillance position. The applicable pathway depends on the device and its earlier conformity route.

Other questions in the guidance concerned what constitutes a formal application, the contents of a written agreement with a notified body, evidence of an IVDR-compliant quality management system and the meaning of a substitute device. The official Q&A documents are the better starting point for those detailed definitions:

• European Commission IVDR transition Q&A
• European Commission MDR transition Q&A

These are the source addresses included in the 2024 article. Before using a deadline or an interpretation in a regulatory plan, confirm that the linked documents and applicable legislation remain current.