European Commission Proposes Simplifying The Rules On EU Medical And In-Vitro Diagnostic Devices

What You Need to Know

Key takeaway #1

The proposed simplification is intended to reduce the administrative burden on EU manufacturers of medical and in-vitro diagnostic devices and lower their compliance-related costs, without adversely affecting public health and patient safety standards. As well as providing improved legal certainty, the Commission aims to boost innovation and bring about a combined annual reduction in costs for the industry exceeding €3 billion.

Key takeaway #2

The suggested changes to the Medical Devices Regulation and the In-Vitro Diagnostic Medical Devices Regulation would amount to the most significant reform of these EU framework regulations since their original adoption. They form part of a broader initiative to boost the EU’s life sciences sector.

Key takeaway #3

The changes are intended to improve harmonization across the EU. In addition, they would, among other things, clarify the rules on classification, streamline clinical evidence requirements, reduce and simplify “notified body” involvement, make the “in-house device exemption” more flexible, and bring the Regulations up-to-date regarding digitalization, AI and cybersecurity.

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.

This client alert highlights some of the key changes and their implications for pharmaceutical and biotech companies, particularly those developing combination products and AI-enabled medical technologies.

Background and rationale

There are more than 38,000 medical technology companies in Europe. Small and medium-sized enterprises (SMEs) make up around 90% of the industry, and most of these SMEs are either small or micro-sized companies employing fewer than 50 people.

A 2024–2025 targeted evaluation found that while the MDR and IVDR strengthened safety and performance benefits, they also caused high and often disproportionate compliance costs because of the regulatory complexity. Stakeholders identified overly complex procedures, limited coordination, lack of innovation pathways, and misalignment with other EU laws (such as the Clinical Trials Regulation 536/2014). They requested simplification, harmonization, and digitalization.

The strict requirements established by the Regulations, which also apply to existing devices, the limited certification capacity of the notified bodies and the insufficient preparedness of the manufacturers are well-known issues. For that reason, the transitional period that was originally specified in Article 120 of the MDR was extended by Regulation (EU) 2023/607 to end either on December 31, 2027 or on December 31, 2028, depending on the device’s risk class and subject to certain conditions. In a similar vein, the transitional periods specified in Article 110 of the IVDR were extended by Regulation (EU) 2022/112 and by Regulation (EU) 2024/1860. They will end on either December 31, 2027, December 31, 2028 or December 31, 2029, depending on the IVD’s risk class and subject to certain conditions, which are similar to those provided for in the MDR. However, the repeated extension of the transitional periods was considered only a short-term solution to mitigate the risk of shortages. It could not solve the underlying structural problems in the implementation of the MDR and IVDR. The Commission is now proposing targeted amendments to tackle those issues.

Classification Clarifications

Under the MDR and the IVDR, devices are divided into four risk classes (I-IIA-IIB-III and A-B-C-D respectively), depending on their intended purpose and inherent risks. Depending on the risk class of the device, the safety and performance requirements are stricter and the manufacturer must involve an independent third-party conformity assessment body (“notified body”) in the conformity assessment, before it can affix a CE marking to the device and place it on the market.

The proposal amends some classification rules, resulting in lower risk classes for certain devices, such as reusable surgical instruments, accessories to active implantable devices and – most notably – software, reducing notified body involvement in some cases.

Furthermore, the proposal contains several provisions on various types of combinations of products that are subject to EU legislative frameworks and the regulatory status of so-called borderline products, where determining the applicable legislative framework is not always clear-cut:

• Products that combine a medical device and an in-vitro diagnostic should be subject either to the MDR or to the IVDR, depending on the product’s principal mode of action, whilst the general safety and performance requirements of the secondary regulation should apply to the part of the device that has the ancillary function. This “principal mode of action” approach is similar to the one for combination products consisting of a medicinal product and a medical device.
• For kits under the IVDR that are in-vitro diagnostics and that integrate products which are subject to other legislation (such as medicinal products), it is clarified that companies developing such kits must ensure each component complies with its applicable legislative framework.
• The competent authorities’ timelines for consultation regarding medicinal products and SoHO (substances of human origin) are reduced in order to lower the costs and length of conformity assessment procedures for medical devices that integrate a medicinal substance or an SoHO.
• For companion diagnostics which may be linked to more than one medicinal product, the consultation of a medicinal products authority should only be necessary regarding novel companion diagnostics and such an authority should not repeat the assessment carried out by a notified body. Streamlined companion diagnostics consultation reduces regulatory duplication for drug-device combinations.
• For combined studies involving medicinal products, medical and/or in-vitro devices, the sponsor may submit a single application, triggering a coordinated assessment and eliminating duplicative regulatory procedures. The Clinical Trials Regulation will be amended accordingly by the proposed Biotech Act (see our client alert on this proposal  here).
• The so-called Helsinki procedure, which details the coordination among competent authorities regarding the qualification and classification of a borderline product or device, will be codified, with the possibility to request opinions from expert panels.

Streamlined Clinical Evidence Requirements

The proposal broadens what counts as clinical data for demonstrating the safety and performance of a device to include studies that are published in scientific literature but not necessarily peer-reviewed. It also enables greater reliance on non-clinical data (including the use of “new approach methodologies” (NAMs), such as in silico testing), and makes the conditions for relying on the clinical data relating to an equivalent device more flexible.

A definition is introduced for a "well-established technology device", which replaces the existing lists of devices in the current Articles 18(3), 52(4) and 61(6)(b) of the MDR. A “well-established technology device” refers to a device that belongs to a generic device group, which fulfils the following cumulative criteria: (i) it has a simple, common and stable design; (ii) it has not been associated with safety issues in the past; (iii) it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art; and (iv) it has a long history on the EU market. Such devices have a lower risk profile than other devices of the same risk class and will therefore be subject to certain exemptions or more proportionate requirements.

Reduced and Simplified Notified Body Involvement

The proposal includes various provisions to reduce and/or simplify the costly and lengthy involvement of notified bodies, such as:

• The maximum period of validity for certificates (currently five years) is removed, unless the notified body considers it necessary to limit the validity on justified grounds. Instead of recertifying devices, notified bodies will carry out periodic reviews proportionate to the risk of the device while the certificate is valid.
• The involvement of notified bodies in the conformity assessment of lower and medium risk devices (classes IIa and IIb, and classes B and C) will be reduced. The technical documentation assessment will only be necessary for one representative device for a generic device group, for a category or for the entire portfolio). No systematic technical documentation assessment of representative devices will be required during surveillance activities. In addition, Class A sterile in-vitro devices will not require notified body involvement as they are considered low risk.
• Notified bodies will have the possibility to replace on-site audits by remote audits. Where justified by an absence of safety issues, surveillance audits will be conducted only every two years. Unannounced audits will be conducted “for-cause”.
• The requirements for a notified body certificate for relabeling and repackaging activities, as well as the prior notice obligation, are removed. Simplified repackaging/relabeling rules benefit companies distributing devices across multiple markets.

Innovation and Availability of Devices for Special Groups

The conditions of the “in-house device exemption”, which concerns the manufacture and use of medical and in-vitro devices within health institutions under certain conditions, are made more flexible to remove unnecessary administrative burden on health institutions, to promote clinical research on in-house devices and to enable the access of patients to in-house devices where no alternatives exist. For example, some documentation obligations will be removed and the transfer of in-house devices between health institutions will be allowed if this is in the interest of patient safety or public health. The condition in the IVDR that there be no equivalent device on the market will be removed. In addition, central laboratories manufacturing and using tests exclusively for clinical trials are added to the scope of the in-house device exemption. The rationale is that such laboratories often develop tests in-house to meet targeted patient needs in clinical trials and the tests are not manufactured on an industrial scale or commercialized.

In addition, the proposal introduces criteria and expert panel "designation" for breakthrough (highly novel) and orphan (used for rare diseases) devices, with priority and rolling review by notified bodies, early advice, and issuance of certificates with conditions where pre-market data are limited but the benefit-risk profile is favorable. Legacy orphan devices that were certified under previous medical device and in-vitro device legislation may continue to be placed on the market beyond the current transitional periods and without a new conformity assessment under the MDR/IVDR, subject to additional conditions and enhanced oversight. This is also known as the “grandfathering” of legacy devices.

Furthermore, the application of the rules on single-use devices is fragmented across the EU and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, manufacturers will be obliged 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. A person who fully refurbishes a single-use device will be the manufacturer of the fully refurbished device.

Lastly, similar to the Pharma Package (for medicinal products) and the proposed Biotech Act, the Member States and the Commission may establish regulatory sandboxes (controlled testing environments) to address needs of emerging technologies within the field of medical and in-vitro devices.

Further Digitalization

The proposal foresees increased digitalization to reduce the administrative burden, and it will be possible to submit communications and compliance documents, including the drawing up of technical documentation, reports, the EU Declaration of Conformity and other documents, as well as the conformity assessment procedure in digital form. Where no specific format is required, digital formats, such as electronic signatures, will be accepted by default.

Furthermore, to ensure a level playing field between devices sold online and those sold via traditional distribution channels, certain information requirements applicable to distance sales will be strengthened. For example, certain essential information necessary to identify the device and the instructions for use will have to be provided in case of online sales. It will also be possible for Member States to order the cessation of activity of providers of diagnostic or therapeutic services by way of online services, on grounds of public health, without prejudice to national laws regulating the medical profession.

AI and Cybersecurity Requirements

Cybersecurity is explicitly added to the general safety and performance requirements (GSPR) in Annex I of the MDR and IVDR. In addition, medical devices and in-vitro devices will no longer be exempted from Regulation 2024/2847 on cyber resilience. There will be mandatory reporting requirements for cybersecurity related incidents (i.e., actively exploited vulnerabilities or severe incidents having an impact on the security of the device), regardless of whether they qualify as a serious incident concerning public health or patient safety (for serious incidents, there is already a parallel reporting requirement in accordance with the vigilance system established under the MDR or IVDR). Cybersecurity related incidents will also need to be reported to the national computer security incident response teams (CSIRTs), and the European Union Agency for Cybersecurity (ENISA) via Eudamed within 30 days.

In addition, to avoid overlapping obligations, the MDR and IVDR are moved from Section A to Section B in Annex I of the Artificial Intelligence (AI) Act.The AI Act follows a risk-based approach with more severe obligations for AI systems deemed “high-risk” because they could significantly harm people’s health, safety and fundamental rights. One way to be considered a “high-risk” AI systems is to be included in the lists of sector-regulated products in Annex I of the AI Act. However, the compliance requirements for Section A of Annex I are notably stricter than the ones for Section B. Products under Section A must comply with high-risk obligations immediately and in parallel with sectoral requirements. On the other hand, products under Section B have an easier compliance path, as they only need to comply with AI-related requirements set out in sectoral legislation. The proposal recognizes that the parallel application of the AI Act and the MDR/IVDR could lead to overlapping requirements, and this could stifle innovation. For that reason, the MDR and IVDR are to be moved from Section A to Section B and only a limited number of provisions under the AI Act will apply to medical and in-vitro devices. Furthermore, notified bodies for high-risk AI-enabled devices will need to meet AI Act requirements. If adopted, this change could significantly reduce the compliance burden for the healthcare sector.

Conclusion

The MDR/IVDR simplification is part of the EU’s life sciences strategy “ Choose Europe for Life Sciences”, which is itself part of the overarching  Competitiveness Compass, and also covered by the Commission Communication “ A simpler and faster Europe”.

The proposed simplification of the MDR and IVDR represents the most significant reform of EU medical device regulation since the original adoption of these frameworks. For pharmaceutical and biotech companies, the changes offer substantial opportunities to reduce regulatory burden, accelerate innovation, and streamline the development of combination products and companion diagnostics. The Commission estimates that, alongside the improved legal certainty, coherence, and innovation-friendliness, the simplification measures will bring about a combined annual reduction in costs exceeding €3 billion.

The proposal will now proceed through the ordinary legislative procedure, with the Parliament and Council each discussing the Commission’s proposal and potentially proposing amendments.

The proposal states that the Regulation would start to apply six months after the day of its entry into force, i.e., 20 days after its publication in the EU’s Official Journal, with a staggered application for certain measures (e.g., the measures regarding the reprocessing of single-use devices would be applicable five years after entry into force).

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.