MDR – IVDR 2.0 – Key push to make it right!

MDR – IVDR 2.0 has, as promised, been published on the 16^th of December (Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices - Public Health). It is great to see that the European Commission has been able to maintain the planned timelines for a major rewrite of the MDR and the IVDR, providing an early Christmas present. Two documents have been issued:

1. A document with a high-level summary of the proposed updates, including justifications, and the proposed updates to the articles of the MDR and the IVDR (170 pages). This document also includes details on the targeted evaluation, an assessment of budget and staff impact, and the digital requirements, with an impact assessment of the proposed updates.
2. A document with the proposed updates to the annexes of the MDR and the IVDR (46 pages).

The high-level summary of the proposed updates gives a great first insight into the proposed changes. The detailed requirements to ensure the safety and performance of medical devices, as documented in the General Safety and Performance Requirements, will not undergo major changes as per the proposed updates, except for the requirements on what constitutes sufficient clinical data and the requirements for biological equivalence. The main changes are proposed for the process to obtain CE marking. In our first discussion after reading MDR and IVDR 2.0, we phrased it as “back to the MDD with some additional requirements and more common sense from a clinical requirements perspective.”

Proposed Changes with the Most Impact

Let’s start with a summary of the proposed changes that may have the most impact on manufacturers of medical devices and IVDs:

• Less NB involvement for class IIa, class IIb, B, and C devices. No systematic TD review will be required for representative devices during surveillance. Furthermore, Notified Body involvement for Class A sterile devices and Class Ir will be removed.
• Surveillance audits will be conducted every other year, and unannounced audits will only be conducted for cause.
• The maximum validity of a CE certificate (5 years) will be removed.
• The definition of Well-Established Technology (WET) devices will be aligned with the definition for WET from MDCG 2020-6. This should allow more legacy devices to be CE-marked under the MDR with limited clinical data.
• The definition of biological evaluation equivalence will be updated to cover “the same and similar materials.” The same applies to clinical equivalence for “the same or similar clinical condition. This is one of the major issues that currently prevents manufacturers from claiming equivalence and thus the use of equivalent device clinical data to support CE marking.
• There will be a legal basis for structured dialogue.
• The options for providing electronic IFU and labeling will be extended.
• The software classification under the newly proposed rule 11 is stricter, resulting in less software being able to claim being an (Sa)MD.
• No NB involvement anymore in repackaging and relabeling requirements.

At first glance, it is a great list of updates that would help manufacturers to reduce the burden in transitioning legacy medical devices to the MDR. But will they really help? With the end of the transition from the MDD to the MDR for class III devices rapidly approaching (31 December 2027), the chance that MDR 2.0 is published and implemented before most manufacturers must submit their Technical Documentation to the Notified Bodies for review is low. Furthermore, many updates focus on maintenance of CE marking and not the initial application for CE marking under the MDR and the IVDR.

What about using the draft MDR 2.0 text to support changing the interpretation of the current MDR requirements? This may be an option for the definition of a WET device, where some Notified Bodies very strictly use the devices listed in article 61(6) of the MDR, even though MDCG 2020-6 includes a broader definition of a WET device. However, this requires that Notified Bodies proactively change their way of working, and this is not what we have been seeing with the conservative approach most Notified Bodies have been taking in the past years.

It is important to note that the impact on IVD manufacturers of those changes will be much greater than for medical device manufacturers. The main change of the IVDD to the IVDR is the radical change in the classification system from list A and list B devices under the IVDD to a risk-based classification system under the IVDR. This classification system remains in place. No major changes that have a positive impact on the transition from the IVDD to the IVDR have been proposed.

Proposed Changes with the Partial Impact

There are also updates proposed that have an impact on only part of the medical devices and IVDs. However, these are not less important as they may have a major impact on the products covered by those updates. Below, a selection of those proposed updates and their potential impact is summarized:

• The CECP will only cover Class III implantable devices. This aligns with the published CECP opinions, which cover 12 out of the 13 published CECP opinions, specifically those related to class III implantable devices.
• PECP will be fully removed as a requirement for IVDs. This is not in line with expectations, as the IVD expert panels have already published 21 PECP opinions. Was the added value of those opinions, in addition to the Notified Body review, more limited than for medical devices?
• Early advice from expert panels for class C and D devices will be possible. In addition, class IIb devices will be added to the option for early advice under the MDR.
• The conditions for the manufacture and use within health institutions will be more flexible. This includes allowing the transfer of in-house devices if this is in the interest of patient safety or public health, and under the IVDR, the condition that there is no equivalent device on the market is removed. Many of those medical devices and IVD in hospitals are used to aid the treatment of patients, making this a major step forward for the hospitals.
• Central laboratories manufacturing and using tests exclusively for clinical trials are added to the scope of the in-house device exemption under the IVDR.
• For a combined study (e.g., a study covering a medicinal substance and a medical device or a medicinal substance and an IVD), a single application process is proposed. This will trigger a coordinated assessment in accordance with Regulation (EU) No 536/2014 on clinical trials for medicinal substances. Important to note here is that currently, a pilot on this coordinated assessment is ongoing. Full implementation may take some time in practice.
• Clinical study authorizations for low-risk IVD studies (e.g., using leftover specimens or only using routine blood draws) will be removed. Additionally, Article 82 in the MDR, which outlines requirements for other clinical investigations, will be deleted. This means in practice that the focus for low-risk clinical studies will be solely on ethical aspects.
• Requirements on conformity assessment for orphan devices and breakthrough devices will be introduced. This includes a reduction of the fees for conformity assessment for those products. This will help to make the EU attractive for these products.

These proposed updates will also definitely help to reduce the burden that the MDR and the IVDR have created for specific products. However, there are also updates proposed that raise questions on how they will help to streamline the process of CE marking for medical devices and IVDs. A selection is discussed below.

• All devices will by default be multi-use. A manufacturer must claim and justify that a device is only single use. This will help in reducing waste from medical devices. However, it also means an extra requirement that manufacturers need to cover and document in the Technical Documentation.
• The role of the expert panels will be extended. They will also be involved in the determination of the regulatory status of products and the classification of devices. Expert panels should also be able to provide scientific, technical, clinical and regulatory advice to the Commission, Member States, the MDCG, and, in some instances to manufacturers. Article 106 indicates that “experts from Notified Bodies shall not be involved in the clinical evaluation consultation procedure provided for in article 54(1).” This can be interpreted as that they can be involved in the expert panels in other capacities. However, what if a Notified Body expert has been involved in other conformity assessments for competitor devices? Is such an expert still considered independent enough to sign a Declaration of Interest? Manufacturers and consultants cannot be considered independent here. Would this mean that the medical device and IVD experts working at universities are the only experts who can be considered for technical and regulatory advice? And what advice is targeted here, and what is the added value of this advice?

This is only a first assessment of the changes proposed in MDR 2.0 and IVDR 2.0. There is further reading, analysis, and interpretation to be done in the coming weeks and months. Let’s work together to ensure that we are all prepared once MDR 2.0 and IVDR 2.0 are issued. However, before that happens, the European Parliament, the Council of the European Union, and the European Commission will enter into a trilogue. This aims to reach an agreement on the proposed updates, resulting in the publication of MDR 2.0 and IVDR 2.0 in the Official Journal of the European Union, and thus updated regulations that can be implemented.

Let’s hope we get a published MDR 2.0 and IVDR 2.0 as an (early) Christmas present in 2026!

To help you navigate these changes, Qserve Group hosts two separate webinars: one for the MDR Update and another for the IVDR Update. Register now: 

• MDR Update | Tuesday, 20th January 2026, starting at 4:00 pm CET
• IVDR Update | Thursday, 22nd January, 2026, starting at 4:00 pm CET.