Amendments to MDR 2017/745 and IVDR 2017/746 Finally Published in the Official Journal

Regulation (EU) 2024/1860 (2024/0021/COD) was published in the Official Journal of the European Union (OJ) on 9 July 2024 making the latest amendments to the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) official. These amendments were originally proposed in January as COM(2024)43 and were later agreed to without changes by both the Council and European Parliament.

The original Commission proposal sought to address three key stakeholder concerns:

1. Continued device availability especially for high-risk class D IVDs
2. Continuity of supply of devices
3. Improved traceability

The published amendments to the regulations address these concerns by incorporating:

1. Extensions to the deadlines by which various classes of legacy IVD devices must be no longer made available on the Union market and updates to the transitional provision for such devices;
2. Obligations on manufacturers to provide advanced notification of withdrawal of certain devices to Competent Authorities (CAs), health institutions (HIs), and healthcare professionals (HCPs) who are supplied these directly; and
3. A gradual implementation of EUDAMED by module.
   Figure 1 provides an overview of the new IVDR transitional arrangements.

Figure 1. Amended IVDR Transitional Arrangements

It is important to look at the details of the transitions and not just the end dates, as misunderstanding of these details could be costly. For example, when the Commission made their proposal, they stated that there were conditions to the amended extensions for IVD legacy devices to “…ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time.” This was achieved by only allowing legacy IVDs for which manufacturers have lodged an application with the NB and had it accepted by specified dates to maintain their legacy devices on market past these dates.

For clarity, to take advantage of the IVDR transition amendments manufacturers must:

1. Continue to meet the IVDD,
2. Not make any significant changes to the device or its intended use/purpose,
3. Have a quality management system (QMS) in place to support the IVDR transition no later than 26 May 2025,
4. Meet IVDR post-market requirements for all devices, not just those that have completed the IVDR transition,
   Once an agreement is signed with the NB for these legacy devices, the NB will become responsible for surveillance.
5. Meet the requirements in Annex XIII and XIV for all clinical performance studies and post-market follow-up studies, where applicable, and
6. Inform CAs, HIs, and HCPs who are supplied devices directly six (6) months prior to any permanent or temporary interruption to supply of devices that may cause serious harm or that may pose a risk of serious harm to patients.

To continue to sell products during the extended transition period for the IVDR, manufactures must lodge an application with the notified body for the devices planned for transition and continue to meet the above conditions for these devices. New devices or devices that have undergone a significant change do not benefit from the extension and are subject to the full IVDR.

The implementation timelines for in-house test requirements described in IVDR Article 5(5) were not changed except for Article 5(5)(d) where labs now have until 31 December 2030 to justify their in-house tests are necessary when equivalent devices are available on the market due to unmet needs for their patients. All other in-house test requirements came into force on 26 May 2024.

The updates related to EUDAMED now allow the Commission to implement the ‘electronic systems’ referred to in MDR Article 33(2) independently as they determine these to be functional and as meeting the predetermined functional specifications. In other words, the updates allow the Commission to implement EUDAMED in modules instead of waiting for EUDAMED to be ‘fully functional’ as was originally required. As a reminder, the electronic systems or modules include:

1. Device registration
2. UDI database
3. Economic operator registration
4. Notified bodies and certificates of conformity
5. Clinical investigations/clinical performance studies
6. Vigilance and post-market surveillance, and
7. Market surveillance.

Going forward, it is essential to understand:

1. The transition timelines for your IVD device(s).
2. The conditions you need to meet to be eligible to use these extensions.
3. Which devices in your portfolio would require notification to CAs, HIs, and HCPs if their supply were to be interrupted or discontinued.
4. The process and timelines by which you would execute required notifications to CAs, HIs, and HCPs for certain devices who supply may be interrupted or discontinued.
5. The dynamics of the notified body application process and the implications of delaying submissions for their review.

There are many factors to consider, we have discussed this in more depth in the EU-IVDR two years on! Webinar now available on demand free of charge and there are further details on our webpage.