EC Requests Feedback on Proposed Regulation to Simplify MDR, IVDR

By Annette Van Raamsdonk

The European Commission (EC) closed 2025 with the publication of a proposal for a revised Medical Devices Regulation (MDR) and In-Vitro Diagnostic Devices Regulation (IVDR). 

In 2024, the European Parliament and stakeholders reached out to the EC with an urgent request to revise the current regulations. After many discussions, letters of stakeholders and workshops during MDCG meetings, the EC offered stakeholders the possibility to provide their feedback in 2025. The outcome of the feedback was published in a report which lists out the reasons why the current regulations do not function as foreseen and therefore do not meet the goals initially set, namely “ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation“. Innovation seems to have stagnated since the MDR and IVDR have been implemented and there are shortages in medical devices and IVDs. Also requirements are disproportionate, as are costs associated with market access. 

There is much more to say about what does not work, but we would like to start this year with a positive note and look into the proposals and how the proposals will benefit stakeholders (if adopted as currently published). 

In a nutshell                 

Disclaimer, this summary does not cover all changes! A more specified regulatory update will follow, listing out changes grouped by Economic Operator and device risk class.

European Medicine Authority (EMA) will become an important institute 

The EMA will get a key role if the proposals are adopted in their current form. The EMA will provide experts, assist with borderline and classification issues and conformity assessment derogations. The door is left open for the EMA to be more involved in clinical evaluation and clinical investigations, as well as vigilance and market surveillance. The role of the EMA seems to be aligned with the suggestion for a centralized “office,” described in the joint motion of the European Parliament sent to the EC in 2024.

Alignment with other regulations

The proposals call for alignment with current regulations as well as new acts, such as the draft Biotech Act, the Clinical Trials Regulation, the Regulation on Substances of Human Origin (SoHO) and the AI Act. The MDR and IVDR will be aligned with these Regulations or existing regulations will be amended.  

The AI Act is amended to remove the MDR and IVDR from Annex I Section A to Section B instead. This would imply that medical devices or IVDs containing AI would not fully need to comply with the AI Act. According to Article 2(2) of the AI Act only Article 6(1), Articles 102 to 109 and Article 112 apply to devices listed in Annex I.B. and “Article 57 applies only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.” Therefore, no additional certification is required.

Extended validity of certificates, remote audits and simplified conformity assessment routes

There’s lots happening here. Not only does the EC propose to extend the validity of certificates, but under certain circumstances, “grandfathering” will be accepted.

The maximum period of validity if certificates will be removed. Notified Bodies (NB) will carry out their periodic reviews proportionate to the risk of the device to determine whether the certificate will remain valid.

NBs will have less involvement in the assessment of lower and medium-risk devices (class IIa and IIb and class B and C). Class A sterile IVDs will no longer need NB involvement. 

For other devices falling into the lower and medium-risk class, no systematic technical documentation assessment of representative devices will be required during surveillance activities. And only the technical documentation of one representative device for a generic device group/category of devices for the entire portfolio will be assessed by the NB.

Orphan devices that were CE marked under the former Directives and for which an expert panel has confirmed that they meet the criteria of ‘orphan device’ may continue to be placed on the market beyond the transitional periods, subject to conditions.

NBs may decide to do a remote-audit. Surveillance audits should be conducted only every two years and unannounced audits are conducted “for-cause” only.

Timelines for consultation of medicinal products and products using tissues of human origin are reduced. 

Distinguishment is made between “prior approval” and “after approval” changes to Quality Management System (QMS) and the approved device. Changes that need prior approval need to be predetermined in a control plan, which is part of the initial NB review.

Article 16 activities (such as repacking and relabeling) will no longer require NB involvement and the obligation to inform the competent authorities is removed.

Reprocessing of single-use devices

Manufacturers will be obliged to provide a justification for a ‘single use’ claim, all others can be reprocessed. Only in the event that a person will fully refurbish a single-use device, they will become the manufacturer. This provision will become mandatory 5 years after the date of application (DoA) of the new regulations. 

Coordination

The processes need to be simplified and streamlined. Governance structures will be more centralized (EMA plays a crucial role here) to avoid overlapping reporting requirements and decrease administrative burdens. This should also decrease costs for both authorities and economic operators.

The EMA will develop a methodology identifying which devices fall in the scope of reporting obligations according to Article 10a MDR/IVDR (interruption or discontinuation of supply of certain devices). The reporting obligations will be integrated in EUDAMED. 

Questions and discussion on the regulatory status and classification of products will be coordinated amongst competent authorities. They will be codified, with the possibility to request opinions from expert panels by economic operators. This process will be streamlined and timelines will be implemented to avoid ongoing discussions and regulatory uncertainty.

EMA will provide the government office for expert panels. The role of expert panels and their composition will be broadened. Expert panels should be able to provide scientific, technical, clinical and regulatory advice to the EC, Member States, the MDCG, NBs and in certain cases to manufacturers.

The EMA will provide scientific, technical and administrative support for the coordination among CAs in several areas, such as borderline and classification, multi- country clinical studies, derogations, vigilance and market surveillance. They will also support small and medium-sized manufacturers.

What else will change? 

Some new articles are introduced related to cybersecurity, international cooperation and reliance mechanisms, Online sales, and the introduction of an “ombudsperson” in the event of discussions between a manufacturer and the NB.

What is next?

The proposal is not yet approved and it depends on the regulatory process when it will take effect. The regular process takes 7-9 months, however, we have seen that the regulatory process can move faster if there is an urgency.  At this moment, the proposal is open for public feedback. This feedback period will end March 5, 2026. Feedback will be evaluated and will probably lead to a second version of the proposed regulations, so we aren’t there quite yet.

Conclusion 

The MDR and IVDR are simplified and should lead to more predictable routes to conformance. Additionally, innovative pathways are introduced and “grandfathering” for orphan devices is introduced. The new proposals make digitalization “the new normal” and a more centralized approach can be expected if the proposals are adopted. 

Some devices require less NB involvement under the proposal and administrative burdens are reduced as well, such as the PSUR frequency and the article 16 MDR certification requirement (repackaging and relabeling by third parties).

As mentioned, there is much more to tell about the proposals. Our Emergo by UL experts will keep you updated and will follow up with more detailed regulatory updates on this topic. So stay tuned!