From Complexity To Clarity: How The EU Commission Plans To Overhaul The MDR And IVDR

Introduction

The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) ("the proposals"). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and a call for evidence in September 2025 (see our blog here). The proposals respond to industry concerns over complexity, cost, and delays which have been substantially hammering the MedTech industry since the implementation of the MDR and IVDR.

The proposals aim to streamline regulatory processes, reduce administrative burden, and enhance predictability, while maintaining patient safety and public health. From adaptive pathways for breakthrough and orphan devices to leaner conformity assessments, stronger notified body (NB) governance, and changes to classification, these changes are designed to future-proof the regulatory framework and foster innovation. For manufacturers, healthcare institutions, innovators, and industry stakeholders, the proposals signal a shift toward a more proportionate, risk-based system that supports timely access to critical technologies without compromising quality.

Below, we have set out an overview of some of the key proposals. Additionally, while not released with the proposals, the European Commission published a draft Implementing Regulation on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies – see our separate blog on this here.

The proposals have now been submitted to the European Parliament and Council for review. Once the Parliament and Council have adopted their own positions on the text, there will be negotiations to agree a final text which can be formally adopted by the Council and the Parliament. At this stage, it is challenging to anticipate what would be the result of the political negotiations and unclear when the new rules will start to apply.

"Breakthrough" and "orphan" devices

The proposals introduce adaptive regulatory pathways to speed up access for breakthrough technologies and orphan devices – two categories previously hindered by lengthy processes.

Devices will qualify as Breakthrough devices if they bring a high degree of novelty technology or clinical application and deliver significant clinical benefits for life-threatening or severely debilitating conditions, either by outperforming existing options or meeting an unmet medical need.

Devices will qualify as Orphan devices where they target conditions affecting fewer than 12,000 individuals annually in the EU and offer clear clinical benefit or address a lack of alternatives.

Once designation as a breakthrough or orphan devices has been confirmed by an expert panel, these devices receive priority and rolling review, early scientific advice, and may be certified with limited pre-market data, provided the benefit-risk profile is favourable and post-market follow-up commitments are in place.

These new statutory pathways build on a previous initiative on orphan devices (see our blog here) and a newly-issued guidance on breakthrough devices.

"Equivalence" and clinical evidence requirements

Manufacturers would be able to rely on "equivalence" with an existing device in a wider set of circumstances rather than conducting clinical investigations. The MDR had in effect ended the "equivalence" route for implantable and class III devices, except where the new and old device are produced by the same manufacturer, or where the manufacturer of the new device had a contract with the manufacturer of the existing device allowing ongoing access to the technical documentation.

The general requirement to conduct clinical investigations instead of relying on equivalence will no longer apply to all implantable devices. This general requirement for clinical investigations will instead apply to Class IIb and Class III devices only.

The requirement to have a contract with the manufacturer of the device with which equivalence is claimed for these types of products will also be removed. Manufacturers will, however, still need sufficient levels of access to data on the devices with which they claim equivalence to demonstrate that equivalence, and will need to provide "clear evidence" that the clinical evaluation of the original device was conducted in accordance with MDR.

Validity of certificates and grandfathering

The proposals overhaul how certificates issued by NBs are managed to reduce administrative burden and improve predictability. Certificates will no longer have a fixed five-year validity; instead, they remain valid indefinitely unless a notified body limits validity for justified reasons, such as pending clinical data. Manufacturers can request extensions where limits apply. Furthermore, previously CE-marked devices under old Directives can remain on the market beyond transitional deadlines if confirmed as orphan by an expert panel.

Active surveillance continues throughout the certificate's lifetime, with periodic reviews proportionate to the device's risk class. The reviews will consider state-of-the-art developments, ensuring devices remain safe and effective over time.

Notified bodies may impose conditions – such as restricting intended use or requiring post-market clinical follow-up – to balance early access with ongoing evidence generation.

Failure to meet requirements can lead to suspension or withdrawal, and all certificate actions will be logged in Eudamed for full transparency.

Classification (including of software medical devices)

A significant challenge in the implementation of the MDR has been the classification rules leading to the "up-classification" of certain products, meaning they are subject to more stringent conformity assessment routes. The proposals seeks to take a more balanced approach to classification than the current regime.

The software medical devices classification rules would be revised. Under the current MDR wording, nearly all software is classified as Class IIa or above, meaning it requires the involvement of an NB in its conformity assessment. The revised wording is intended to allow more software to fall within Class I. However, it is unclear to what extent the revised wording would achieve this effect.

There are also changes to the classification rules for various other product types.

Borderline and Classification Processes and Dispute Resolution

There would be greater coordination between Member States in determining borderline and classification issues, i.e. respectively whether a given product qualifies as a medical device, and its risk classification. This is with the aim of making it more straightforward for manufacturers to confirm the status and classification of their product, and ensuring harmonisation in the application of the MDR and IVDR across the EU.

Measures include codifying the so called 'Helsinki Procedure' under which Member State competent authorities seek to agree on the regulatory status and classification of a product. Member States will have new obligations to coordinate decision-making with the other Member States, and must also consult with relevant competent authorities under product regulatory regimes with which there is a borderline issue.

Expert panels will be given an important role in helping to determine the status and classification of products, with mandatory referrals to expert panels in certain cases and the option for Member States to request an expert panel opinion in other scenarios.

There will also be a new dispute resolution mechanism for when manufacturers and NBs disagree on the classification of a product, with escalation to Member State competent authorities.

Notified Body oversight and governance

The proposals introduce significant reforms to how NBs operate, aiming to improve predictability, reduce administrative burden, and harmonize practices across the EU.

Structured Dialogue: Manufacturers and NBs will have a formal framework for pre- and post-submission dialogue, following documented procedures, ensuring clarity and reducing delays through documented procedures.

Risk-Based Conformity Assessment: NB involvement will be scaled back for lower and medium-risk devices, focusing on one representative device per category. Other changes include:

• Routine technical checks during surveillance will be dropped unless concerns arise,
• remote audits may replace on-site visits,
• surveillance audits can occur every two years, and
• unannounced audits will be "for-cause" only.

Streamlined Designation and Monitoring: Joint assessment teams, comprising national authorities, Commission experts, and Member State representatives, will handle NB designation and biennial monitoring. The five-year full reassessment requirement is removed.

Dispute Resolution: Each authority responsible for NBs will act as an ombudsperson in disputes between manufacturers and NBs, aimed at providing a neutral forum for resolving conflicts quickly and fairly.

Coordination Across the EU: NBs must actively participate in the NBs Coordination Group (NBCG-Med), and NBCG-Med will report directly to the Medical Device Coordination Group (MDCG), aimed at ensuring harmonized practices, reducing fragmentation and improving consistency across Member States.

Post-market obligations

The proposals adjust the frequency and timelines for certain post-market reporting requirements. For example, manufacturers would have 30 days instead of the current 15 days to report serious incidents. In addition, the proposal reduces fixed Periodic Safety Update Report update frequencies by replacing the annual update requirement for class IIb and class III devices with a biennial cycle after the first year following certification, and by removing the minimum two-year update requirement for class IIa devices. This would instead be updated when necessary, based on post-market surveillance data.

Regulatory sandboxes

The proposals introduce the possibility to establish regulatory sandboxes at both national and Union level, acknowledging that certain innovative technologies require practical testing to fully understand how regulatory requirements apply. This may be particularly relevant for software medical devices, including those using artificial intelligence, where issues relating to data use, clinical evidence, algorithm behaviour or performance monitoring often become apparent only through real-world or simulated testing. Under the proposed framework, participation would be subject to defined eligibility criteria, time limits, and supervisory conditions, with manufacturers required to agree in advance on the scope of activities, safeguards and reporting obligations. Testing would take place under the oversight of the relevant authorities and without affecting the applicability of the substantive MDR/IVDR requirements.

International reliance and cooperation

The proposal builds on the Commission's existing participation in international regulatory fora and cooperation initiatives in the field of medical devices and IVDs by providing a clearer legal basis for such activities under the MDR and IVDR. It explicitly recognises the importance of cooperation with third countries and international organisations, including the exchange of regulatory information and experience. While this does not change the requirement for full compliance with EU regulatory obligations, it may support greater international alignment over time.

Notably, the proposals open the door to reliance on the assessments, inspections and other regulatory decisions of the regulators of other jurisdictions where the EU participates in bilateral or multi-lateral reliance programmes.

IVD In-house exemption

The proposals introduce targeted changes to the rules for health institutions and clinical laboratories that manufacture and use devices in-house. These devices are vital when no equivalent product exists on the market, enabling rapid responses to unique patient needs. While core safety requirements remain, the revisions aim to reduce unnecessary burden by easing documentation obligations (particularly for EN ISO 15189-accredited institutions), allowing transfers between health institutions for public health reasons, and granting a long transition period when a market alternative becomes available. For in-house IVDs, the condition that no equivalent device exists will be removed to strengthen emergency preparedness. Additionally, laboratory-developed tests used exclusively in clinical trials – when not industrially produced or commercialized – will benefit from the same exemption framework, supporting research without imposing disproportionate compliance costs.

Other changes include:

• Digitalisation of Compliance Tools: EU declarations of conformity and certain labelling information can be provided in digital form. Electronic submission of MDR/IVDR information becomes mandatory, reducing paper-based processes.

• Cybersecurity Requirements: Explicit inclusion of cybersecurity in general safety and performance requirements. Manufacturers must report actively exploited vulnerabilities and severe incidents to national CSIRTs and ENISA via Eudamed.
• Combined Studies: Sponsors conducting combined studies involving medicinal products, medical devices, and/or IVDs can submit a single application under a coordinated assessment procedure.
• Changes to Clinical Evidence Rules: Broader acceptance of non-clinical data (including in silico and other New Approach Methodologies) for demonstrating safety and performance. Flexibility to rely on published literature and remove the requirement for contractual access to technical documentation when claiming equivalence.

• Reprocessing of Single-Use Devices: Manufacturers must justify single-use claims; devices not intended for single-use can be reprocessed under manufacturer instructions.
• Well-established technology devices: A definition has been included, and these devices will be subject to more proportionate requirements. Previously, MDGC guidance used this term to describe legacy devices eligible for reduced clinical data requirements.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.