On December 16th, 2025 the EU Commission published their proposal for updates of the EU MDR and EU IVDR (Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices - Public Health). The proposal includes significant changes for the process for CE marking with the goal to simplify the regulations and reduce administrative and regulatory burdens for EU market access. It also introduces a new pathway for conformity assessment of innovative devices and orphan devices.
What’s in it for IVD manufacturers?
First of all, the IVDR will not be abandoned and there is no additional extension of the timelines for transition of IVDD legacy devices. If you have class C legacy devices that still need to make the transition you have only a few months left to ensure that you have lodged a formal agreement with one of the IVDR Notified Bodies – the due date is 26 May 2026. And keep in mind that the proposal still needs to be agreed with the EU Parliament and the EU Council, and implementation may take several months.
From the perspective of IVD manufacturers the most promising change is probably the relaxation of the requirements for performance evaluation and clinical evidence to support the safety and performance of the device. There will be more flexibility for generating the clinical data since in addition to clinical performance studies, studies published in scientific literature or clinical experience published in peer-reviewed literature for the original device, data generated for a device demonstrated as equivalent will also be acceptable. And there will also the possibility to support performance data by computational modelling and in silico testing.
In case you have to conduct a clinical performance study, study authorization will not be required anymore for non-interventional studies that collect samples unless the specimen collection involves high-risk procedures for the subjects.
IVDR 2.0 also introduces the option to request advice on the intended strategy for demonstrating clinical performance or the design of clinical performance studies for class C and D devices from an expert panel. Both Notified Bodies and manufacturers have to follow this advice for the performance evaluation unless they can provide a justification.
Furthermore, the required technical documentation will be simplified. Instead of separate reports, the scientific validity, analytical performance and clinical performance can be documented in dedicated sections of the Performance Evaluation Report. For class C devices, the Summary of Safety and Performance (SSP) is no longer necessary with the exception of Companion Diagnostics and device for self-testing. And the frequency of Periodic Safety Update Reports (PSUR) updates for class C and D devices is reduced to bi-yearly, with the first report requires one year after the certification. The proposal also clarifies that for class C and D device only the PSUR and not a Post Market Surveillance Report is required. In addition, electronic Instructions for Use are introduced for all IVDs for professional use, including Near-Patient-Tests.
Lastly, the validity of IVDR certificates will no longer be limited unless the certificate has been released under conditions. The Notified Bodies will perform surveillance activities with surveillance audits every other year and sampling of Technical Documentation.
More flexibility for use of the in-house exemption (Article 5.5)
Under the proposed updates, in-house tests may be transferred from one health institution to another one if that is in the interest of public health, patient safety or patient health. Furthermore, the health institution, typically a medical laboratory, does not need to justify anymore that an in-house test is needed because there is no equivalent device available on the market. For medical laboratories that are accredited under ISO 15189, the documentation requirements are reduced and a declaration that the device meet the general safety and performance requirements (IVDR Annex I) is not needed anymore. In addition, clinical laboratories that provide testing services for pharmaceutical clinical trials can now also make use of the in-house exemption.
Companion Diagnostics and combined studies
For manufacturers of Companion Diagnostics and pharma companies that use investigational IVDs in pharma clinical trials there are also significant improvements. As mentioned above, clinical laboratories that conduct biomarker testing for pharma clinical trials will be able to benefit from the in-house exemption. The proposed IVDR update also defines Combined Studies, studies covering a medicinal substance (drug) and an IVD. For these studies the sponsor may choose to follow the Clinical Trial Regulation instead of the IVDR requirements with coordinated study authorization for all involved EU member states. For Combined Studies endpoints that are reporting on the device and medicinal product together may be used. Another improvement is the removal of the requirement for notification of studies for Companion Diagnostics conducted with left-over samples where the test results are not used for patient management decisions. For follow-on Companion Diagnostics, the conformity assessment will no longer involve an assessment by the European Medicines Agency (EMA) if the manufacturer can demonstrate equivalent performance to the CE-marked Companion Diagnostic.
Stay Tuned
- This article is part of Qserve’s series on MDR and IVDR 2.0, where we’ll explore the key areas of impact and their practical application.
- Need support? From change assessments and regulatory interpretation to hands-on implementation support tailored to your organization, we help you navigate compliance with confidence.
- 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.