Since their proposal in early 2024, the MedTech industry has been awaiting the formal publication of the latest round of amendments to the EU MDR 2017/745 and IVDR 2017/746. The amendments have now been formally published in the form of Regulation 2024/18601. The regulations cover three topics as shown below.
MDR | IVDR | |
Amendments to the transition timeline for legacy IVDs that gives manufacturers additional time to keep their IVDD legacy devices on the market, provided they meet certain conditions. | ✔ | |
Amendments to the requirements for the roll-out of EUDAMED, to enable the completed modules to be launched for mandatory use without waiting for all six of the EUDAMED modules to be completed. | ✔ | ✔ |
A new obligation for manufacturers to notify their competent authority in the event of anticipated interruptions or discontinuations in supply of devices, where the absence of shortage of said devices could put patients at significant risk. | ✔ | ✔ |
Changes to the Transitional Timelines for IVDR (EU) 2017/746
Despite the extension to the transitional timelines in 20222, the commission has identified a risk of shortages for IVDs, especially high-risk devices, which had a transition deadline of 26 May 2025. The amendment pushes the existing transition deadlines out by a further 2.5 years. The exact transition deadline is dependent on the classification of the IVD device. Like the amendments to the MDR transitional arrangements (Regulation 2023/607), these extended timelines for legacy IVDs come with conditions to enable manufacturers to take advantage of the additional time:
- The device must continue to comply with the IVDD as well as the transitional provisions of IVDR Article 110(3). This includes meeting vigilance and post market surveillance requirements for IVDR.
- The device must not undergo any significant changes in design or intended purpose.
- The device must not present an unacceptable risk to the health and safety of the patient, users or other persons, or to other aspects of the protection of public health.
- The manufacturer must put in place an IVDR compliant quality management system (QMS) no later than 26 May 2025.
- The manufacturer must have lodged a formal application for IVDR with a notified body and within four months, the application must be covered by a written agreement between the notified body and the manufacturer. Unlike the extended transition under the MDR (Regulation 2023/607), these dates differ for each classification of upclassified product as shown below.
For IVDs classed as ‘general’ under the IVDD that have now been upclassified under the IVDR, their new transition dates are as follows:
IVDR Classification |
QMS in place according to |
Lodged application for conformity assessment with notified body (NB) |
Contract in place with NB for conformity assessment |
End of transition period |
Class D | 26 May 2025 | 26 May 2025 | 26 Sep 2025 | 31 Dec 2027 |
Class C | 26 May 2025 | 26 May 2026 | 26 Sep 2026 | 31 Dec 2028 |
Class B & Sterile Class A |
26 May 2025 | 26 May 2027 | 26 Sep 2027 | 31 Dec 2029 |
List A and List B IVD devices under the IVDD now have an extended grace period up to 31st December 2027.
IVD manufacturers with devices on the market under IVDD (self-declared or through notified body) will have additional time to make the transition to IVDR. The new transition deadline and conditions are similar to what is in place for MDR, so notified bodies are expected to leverage the same procedures already in place for the MDR transition. Self-declaration templates3 and NB confirmation letter templates4 have recently been created for the IVDR transition despite the Commission’s Q&A5 stating that the existing MDR templates are acceptable (with edits) for the IVDR transitional period too.
The amendment also extended the deadline for the application of Article 5 (5d) where healthcare institutions are required to justify that their specific needs cannot be met by an equivalent device as part of their supporting evidence for in-house manufactured IVDs. This requirement is now applicable from 31 December 2030 rather than 26 May 2028.
RQM+ Recommendations:
- Remember that plans are living documents that should be revisited and updated in light of new information. The amendments to the transitional period for IVDs may give certain products or product families a new lease of life. The introduction of the ‘substitute device’ concept may also reinvigorate plans for legacy devices that are due to be replaced by new design iterations.
- Don’t delay in ensuring that your QMS complies with the requirements of IVDR 2017/746 Article 10(8). Make sure that you consider the content of Annex ZB of EN ISO 13485:2016 / A11:2021 and all the relevant MDCG guidance documents.
- Use the templates provided to ensure that you have supporting evidence for the extended validity of your expired, or soon-to-be expired, certificates.
- Don’t be complacent. As with the extended MDR transition timelines, the extensions for the IVDR transitional arrangements are principally to give the notified bodies sufficient time to process the IVDR applications. Notified bodies have capacity for IVDR transitions and applications now; waiting until closer to the applicable transition deadlines increases the risks for your project.
- Use the time wisely. On the flip side, you may wish to use the extra time afforded by the extensions to plan for, and collect, additional clinical data either from performance studies or post-market performance follow-up studies.
EUDAMED Roll Out
The amendment removes the current requirement that EUDAMED cannot become mandatory until all modules are fully functional. Instead, it allows completed modules to be released and their use becomes mandatory before the entire system is operational. This amendment applies to both the MDR and IVDR. The current status and planned/estimated notification date are tabulated below6.
EUDAMED Modules | Available for voluntary use |
Planned OJEU publication date 6 |
Actors | AVAILABLE | Jul 2025 |
Vigilance | Q4 2024 | Jan 2026 |
Clinical Investigation & Performance studies | Q3 2026 | Q2 2027?* |
Market surveillance | Q4 2024 | Jul 2025 |
UDI/Device | AVAILABLE | Jul 2025 |
NB & Certificate | AVAILABLE | Jul 2025 |
*Estimated based on [6] and previous output from European Commission
This change is being driven largely by the delays to the final EUDAMED module for clinical investigations and performance studies, which is not expected to be complete until Q3 of 2026. Delayed development of this module under the previous MDR and IVDR framework would delay mandatory use of any of the other modules. EUDAMED is key for competent authorities and the Commission for market surveillance and should also result in benefits for manufacturers such as the visibility of post-market data on competitor products in the EU.
RQM+ Recommendations:
- Get ready now. The notification that certain modules are ready could be published in the Official Journal in just 12 months; 6 months after which the use of those modules will be mandatory. Depending on the volume of products in your catalogue, the generation and collation of the data required for entry into EUDAMED could be a very time-consuming task; and one that should not be left until the notification is published in the Official Journal.
Interruptions of the Supply Chain & Product Discontinuations
Key stakeholders have indicated that during the transitional period for MDR and IVDR, the supply of many medical devices and IVDs has, or will be, stopped (temporarily or permanently). If there are no alternatives on the market, this interruption in supply will have a critical impact on patients and public health.
The amendment introduces a new article (Article 10a) to both the IVDR and MDR. This new article lays down an obligation for manufacturers to give prior notice about any interruptions or discontinuations of the supply of certain critical medical devices and IVDs. The notification must be sent to the national competent authority of the member state in which the manufacturer, or their authorized representative, is based. This notification must occur at least six months before the anticipated interruption or discontinuation. The manufacturer must also notify their affected customers (e.g. health institutions, healthcare professionals and relevant economic operators). The competent authority is responsible for informing the other competent authorities also impacted by the interruption or discontinuation.
This is a completely new requirement for medical devices and IVD in the EU, although equivalent requirements are already in place in the EU for pharmaceuticals, and for medical devices in specific member states (e.g. France7) and elsewhere (e.g. US8 and Canada9).
This new obligation comes into force on 10th January 2025, but there are still a lot of unknowns relating to this somewhat vague obligation for manufacturers. For example:
- Will there be a specific and legally-binding list of medical devices and IVDs that will be in scope?
- Will there be standardised risk criteria to ensure consistent decisions on reporting from manufacturers?
- How will interruptions due to force majeure situations be treated by the competent authorities?
Guidance on this new obligation for manufacturers is expected from both the Commission (in the form of a Q&A document) and the MDCG.
RQM+ Recommendations:
- Prepare. If this requirement is completely new to your organization, you need to determine whether the intended purpose of your device, the clinical context in which it is used and the market for the device create a situation where the loss of your device from the market could lead to serious harm etc.
- Plan. Establish processes that will help you detect anticipated interruptions to the supply chain, assess the risk and make decisions on whether notifications are required.
- Assess. Just like when communicating Field Safety Notices, the notification of interruptions and discontinuations could be an exhausting exercise. Check that you have adequate contact information for distributors and customers that would need to be notified in the event of interruptions or discontinuations.
RQM+ Services to Help Smooth Your IVDR Transition
IVDR Planning and Execution: RQM+ delivers business-balanced strategy and tactical execution for transitioning companies of all sizes to the EU In Vitro Diagnostic Regulation (IVDR). See here to learn how our industry insights and collective knowledge contribute to comprehensive compliance strategies and business-balanced solutions.
Performance Evaluation Solutions: RQM+ provide a complete and integrated solution for PEPs, PERs, PMS plans, PMPF plans, risk management, and labeling, with regulatory strategy applied throughout the process. This ensures you put your best foot forward for IVDR approval. Learn how RQM+ can add value to your IVDR performance evaluation efforts.
Quality System Regulations and Standards: Regulatory requirements for quality management systems are constantly evolving, and it is up to manufacturers to stay abreast of the changes and stay compliant. The RQM+ team can help you implement best practices for keeping products and associated documentation up to date and compliant.
Comprehensive Audit Programs: From internal audits to multiyear agreements auditing your entire supply chain, RQM+ has you covered. Learn all of the ways we help with auditing everywhere in the world and in any language.
Acquisition Integration for Medical Devices and IVDs: Acquiring a new company or product line can have a positive business impact, but it also comes with regulatory and quality challenges. RQM+ uses a customized, business-balanced approach and proven practices to integrate new acquisitions into your quality systems.
More RQM+ Resources at Your Fingertips:
- Read our blog on 5 Tips for IVDR Certification of Companion Diagnostics
- Revisit our MDR blog about what to do during the transition: Musical Chairs MDR-Style: Keep dancing even though the music has stopped
- Catch up with our Live! show on IVDR Class D devices, focusing on Advanced Strategies for Succeeding In a Dynamic Regulatory Environment
- Watch the recording of our Live! show: Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
- Follow RQM+ on LinkedIn for all our updates!
- View our RQM+ Live! panel discussion this topic - MDR and IVDR Amendments: Strategies for Supply Interruption Compliance

References
- Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices | URL
- Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices | URL
- MedTech Europe - Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860 | URL
- Team-NB - Notified Body Confirmation Letter – EU 2024/1860 (v2) | URL
- EXTENSION OF THE IVDR TRANSITIONAL PERIODS: Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices | URL
- Updated Timeline - Current planning for gradual roll out and modules’ functionality view | URL
- LOI n° 2023-171 du 9 mars 2023 LOI n° 2023-171 du 9 mars 2023 portant diverses dispositions d'adaptation au droit de l'Union européenne dans les domaines de l'économie, de la santé, du travail, des transports et de l'agriculture | URL
- Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | URL
- Medical device shortages: Overview | URL