The EU’s Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) Regulations were introduced to strengthen public health protection and patient safety. However, a recent evaluation revealed that they created several challenges for industry. In this context, the European Commission announced measures aimed at strengthening the EU’s health sector, boosting innovation, ensuring global competitiveness, and improving public health outcomes, without compromising safety. These initiatives include a proposal to simplify EU rules for medical devices, published in December 2025.
The proposal has no legal effect. The text has been submitted to the European Parliament and the Council. To become binding law, the co-legislators need to adopt the text by ordinary legislative procedure.
Selected key changes proposed to amend the MDR and IVDR
Will the PRRC still be required?
Yes, but the Commission is proposing to remove detailed qualification requirements for the PRRC and to remove the obligation that SMEs, which rely on an external PRRC, need to have the PRRC “permanently and continuously” available, but only “available”.
What could change concerning the validity of certificates and recertification?
The Proposal includes the removal of the maximum period of validity of certificates (currently 5 years). Instead of recertification, notified
bodies will carry out periodic reviews proportionate to the risk of the device.
What could change for clinical evidence, non-clinical data, and clinical data?
Under the MDR, a wider range of data could qualify as clinical data. In addition, the conditions for relying on clinical data of an equivalent device could be made more flexible. In particular, under Article 61 the possibility to demonstrate a device’s safety and performance based on non-clinical data alone is expanded.
Is there going to be a definition of “well-established technologies device”?
Yes, the Commission is proposing to introduce a definition of “well-established technologies device” be subject to more proportionate
requirements, replacing the lists of devices in the current Articles 18(3), 52(4) and 61(6)(b) of the MDR.
Are classification rules addressed?
Yes, MDR classification rules could be adjusted. The Commission is proposing to adapt classification rules, resulting in lower risk classes for certain devices. These include reusable surgical instruments, accessories to active implantable devices, and software, among others.
Is the update frequency of periodic safety update reports (PSUR) going to be reduced?
Yes, the Commission is proposing to reduce the frequency of PSUR updates.
Is the reporting timeline of certain serious incidents in the framework of vigilance going to be prolonged?
Yes, the Commission is proposing 30 days instead of 15 days for serious incidents which are not related to public health threats, death or serious deterioration of health.
What does the proposal introduce to support innovation for devices targeting special patient groups?
The proposal introduces dedicated pathways for breakthrough and orphan devices. These are intended to facilitate quicker access to safe and effective technologies designed for rare diseases, niche clinical needs, or highly specialised patient groups.
How are the conditions for manufacturing and using in‑house devices becoming more flexible?
Among others, the proposal makes the rules less restrictive by allowing certain additional activities, such as the transfer of in‑house devices between health institutions, when this is justified by patient safety or public health interests. In addition, under the IVDR, the condition that there is no equivalent device on the market is removed.
What new mechanisms are introduced to manage the interruption or discontinuation of supply of certain medical or in‑vitro diagnostic devices under MDR and IVDR Article 10a?
The Commission is proposing the introduction of a central IT tool available in EUDAMED, or via an interoperable platform, to enable structured reporting and timely information exchange between manufacturers, authorities, and other relevant actors. Additionally, the European Medicines Agency (EMA) will develop a methodology to identify which devices fall under the reporting obligation and will compile an official list of such devices.
How will conformity assessment procedures change for breakthrough and orphan devices?
Once designated by an expert panel, breakthrough devices and orphan devices become eligible for a priority and rolling review process. This accelerated pathway is designed to speed up access to innovative or rare‑disease technologies.
What new rules does the Proposal introduce regarding the reprocessing of single‑use devices?
The proposal includes an obligation for manufacturers to provide a justification for a ‘single-use’ claim. All devices that are not intended for single-use can be reprocessed in accordance with the instructions provided by the manufacturer.
Are conformity assessment procedures going to change?
Yes, the Commission is proposing to reduce the involvement of notified bodies in the conformity assessment of lower and medium risk devices (class IIa and IIb and class B and C).
Are notified body fees going to stay the same?
No, the proposal includes fee reductions for micro and small manufacturers and for orphan devices.
What does the proposal include to enhance digitalisation?
The proposal includes several measures to enhance digitalisation. Among others:
- Digital EU declaration of conformity.
- Certain information on the label may be provided in digital form.
- Manufacturers of near-patient tests will be able to provide electronic IFUs.
- Electronic submission of information pursuant to MDR/IVDR.
- Economic operators will have to provide digital contacts on EUDAMED.
- Manufacturers may draw up technical documentation, report and other documents in digital form.
For any questions on compliance of your medical devices, contact MDlaw Team here or at mdlaw@obelis.net.
References:
European Commission (2025). Proposal for a Regulation of the European Parliament and the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I. Retrieved on 22/01/2026.
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