Publication date: February 25, 2026
Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) are twin regulations issued on the same day, aimed at regulating medical devices sold in the European Union. The MDR governs the making available on the market, placing on the market, and use of medical devices. The IVDR establishes the same framework for in vitro diagnostic medical devices, but also covers the rules for marketing these products (including complaints and adverse reactions).
Although these regulations have been in force for several years, they are entering the market in stages. At the time of writing (January 2026), some provisions from the most recent amendment (in 2024) had not yet entered into force. This is due to the complexity of the regulations, which made compliance difficult for many entities. However, the two amendments proved insufficient, and the Commission submitted a proposal for another amendment in December 2025.
The MDR regulates medical devices, which can be any instrument, apparatus, device, software, implant, in vitro reagent, or other material or article intended by the manufacturer to be used—alone or in combination with other materials or articles—in humans for a medical purpose, such as diagnosing, treating, mitigating, preventing, monitoring, predicting, or prognosing a disease, injury, or other condition. This is therefore a very broad definition, encompassing very simple products, from surgical masks to implantable cardiac pacemakers. They are regulated based on the risk they may pose and their intended purpose, dividing products into four classes. Initially, the regulations introduced strict requirements and a rigorous conformity assessment system to ensure the high quality and safety of products placed on the EU market. Due to the low number of notified bodies at the time of their introduction, the certification process was very difficult. However, this problem has now been resolved. However, other issues remain, prompting the need for further amendment. This article aims to present the reasons and objectives of the proposed changes, outline the changes themselves, and attempt to describe their main consequences.
Reasons and goals of change
In its document outlining the proposed changes, the Commission also outlined the reasons for the proposed changes in bold. The primary goal is to streamline and adapt the regulatory framework to future challenges. In its current form, the regulations impose significant administrative burdens on manufacturers, creating unpredictable rules and complex and cost-ineffective certification procedures. Furthermore, the changes aim to adapt the rules to market realities, as some provisions are currently perceived as disproportionate to the actual risks posed by products.
Overly burdensome requirements can induce manufacturers to discontinue supplying devices or delay their introduction to the market, which can have negative consequences for patient care and public health. They can also negatively impact the competitiveness of the EU medical devices market vis-à-vis other jurisdictions. Current rules, considered fragmented and non-harmonized, have led to a number of inefficiencies and unnecessary burdens for stakeholders (primarily manufacturers). According to the Commission, the administrative burden stems from reporting requirements and duplication of work, which is particularly burdensome for small and medium-sized enterprises (SMEs). In addition to reducing market competition, unclear rules also reduce support for innovation, which requires supportive and flexible mechanisms. Regulations result in disproportionate costs for manufacturers, especially SMEs.
An important aspect of the proposed changes is the attempt to create a more centralized approach and greater involvement of notified bodies in the conformity assessment procedure. Currently, many of these issues are left to the discretion of Member States. The Medical Device Coordination Group (MDCG), established under Article 103 of the MDR, will be retained as the main governing body. However, it will be closely monitored by experts from the Commission. The changes are generally aimed at increasing expert involvement.
The desire to implement the changes stems from an evaluation conducted by the Commission, as well as an evaluation to which stakeholders – including manufacturers – were invited. This evaluation revealed that the problems identified by the Commission are shared by market participants, who also agree with the proposed changes. However, it is crucial that the benefits for patients and healthcare systems – strengthening the safety and performance of devices and increasing transparency – remain the primary goal. Nevertheless, it is estimated that the changes will continue to ensure patient safety while achieving a measurable impact of approximately €3 billion.
Following consultations and its own evaluation of the MDR and IVDR, the Commission is proposing a number of changes, which are discussed below. In addition to the changes to the MDR and IVDR, the proposal includes minor changes to Regulation 2002/123 on crisis preparedness for medical products and Regulation 2002/1689 on artificial intelligence. The Commission has divided the proposed changes to the MDR and IVDR into eight sections and will be described in this article.
Issue 1: Simplification and Proportionality
The Commission proposes to remove the detailed requirements for the qualification of the person responsible for regulatory compliance (PRRC) and to remove the obligation for SMEs using an external PRRC to have it available “permanently and continuously” – it is sufficient that it is only available [Article 15 MDR; Article 15 IVDR]. The maximum validity period of certificates (currently 5 years) will be abolished. Instead of recertifying devices, notified bodies will conduct periodic reviews proportionate to the risk of the device during the validity of the certificate [Article 56 MDR; Article 51 IVDR]. A broader range of data will be considered clinical data. The conditions for relying on clinical data of an equivalent device will become more flexible. Article 61 MDR plans to extend the possibility of demonstrating the safety and performance of a device solely on the basis of non-clinical data. The use of “New Approach Methodologies” such as in silico studies is promoted [Article 2(48), Article 6, Annex II and XIV MDR; Annex XIII of the IVDR]. A definition of “well-established technology device” will be introduced for devices, which will 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 [Article 2(72), Article 18, Article 32, Article 52, Article 61 and Article 86 of the MDR].
The requirement for a notified body certificate for relabelling and repackaging activities, as well as the obligation for prior notification, is to be removed [Article 16 of the MDR; Article 16 of the IVDR]. Some classification rules are to be adapted, resulting in lower risk classes for certain devices, such as reusable surgical instruments, accessories to active implantable devices and software [Annex VIII of the MDR].
Issue 2: Reducing administrative burden
The scope of devices for which the manufacturer must provide a summary of safety and (clinical) performance (SS(C)P) will be limited to devices for which a notified body must carry out an assessment of the technical documentation. Because the draft SS(C)P is part of the documentation submitted to the notified body, separate validation by the notified body will no longer be required [MDR Article 32; IVDR Article 29]. The frequency with which manufacturers are required to update periodic safety update reports (PSURs) will be reduced. The review of PSURs by the notified body will be part of its supervisory activities [MDR Article 86; IVDR Article 81]. Manufacturers will have 30 days (instead of 15 days) to report serious incidents that are not associated with risks to public health, death or serious deterioration in state of health [MDR Article 87; IVDR Article 82]. The notified body will have to distinguish between changes to the quality management system or the approved device that manufacturers may implement without prior notification, without prior approval, or only after approval by the notified body. Where appropriate, the notified body and the manufacturer will have to agree on an established change control plan [Annex VII of the MDR; Annex VII of the IVDR]. Finally, performance studies involving only routine blood sampling will no longer be subject to prior approval. The obligation to notify performance studies on companion diagnostics using leftover samples will be removed [Article 58 of the IVDR].
Issue 3: covering innovation and product availability for specific patient groups and situations
The conditions for manufacturing and use in healthcare facilities are to be made more flexible (e.g., allowing the transfer of proprietary devices if this is in the interest of patient safety or public health). The IVDR is to remove the requirement that there is no suitable equivalent device on the market. Central laboratories manufacturing and using tests exclusively for clinical trials will be added to the scope of the waiver for proprietary devices [Article 5(5) of the MDR; Article 5(5) of the IVDR]. A central IT tool for reporting and information exchange will be made available in the Eudamed database or will be interoperable with it. The EMA (European Medicines Agency) will develop a methodology for identifying devices subject to the reporting obligation and compile a list of such devices [Article 10a of the MDR; Article 10a of the IVDR]. Criteria for breakthrough and orphan devices will be introduced. After “designation” by an expert panel, breakthrough and orphan devices will be subject to priority and rolling review. Manufacturers will have access to advice from expert panels [new Article 52a of the MDR; new Art. 48a IVDR]. The Commission will be able to authorize the placing on the market of devices on its own initiative in the event of a public health emergency. Competent authorities will be able to authorize derogations regarding the manufacture, design or intended purpose of CE marked devices during serious cross-border health threats, disasters or crises [Art. 59 and new Art. 59a MDR; Art. 54 and new Art. 54a IVDR]. Member States and the Commission will be able to establish regulatory sandboxes to meet the needs of emerging technologies [new Art. 59b and new Art. 59c MDR; new Art. 54b and new Art. 54c IVDR]. Manufacturers will be required to provide justification for the “single use” designation. All devices that are not intended for single use may be reprocessed in accordance with the instructions provided by the manufacturer. A person who fully reprocesses a single-use device will be considered the manufacturer of that device. This provision will apply five years after the entry into force of [Art. 17 MDR]. Clarification will be provided regarding the composition of kits as defined in Art. 2(11) IVDR [new Art. 19a IVDR]. Orphan devices that were CE marked under the old directives and for which an expert panel confirmed that they meet the criteria for an “orphan device” may continue to be placed on the market after the transitional periods, under certain conditions [Art. 120 MDR; Art. 110 IVDR]. The outdated definition of nanomaterial in Art. 2 MDR will be deleted and replaced by a reference to the Commission Recommendation of 10 June 2022 on the definition of nanomaterial in the provisions of Annex I and Annex VIII on nanomaterials [Annex I and Annex VIII MDR].
Issue 4: Regarding the predictability and profitability of certification
A legal basis will be introduced for notified bodies and manufacturers to conduct a structured dialogue, based on documented procedures, before and after the submission of an application [Annex VII of the MDR; Annex VII of the IVDR]. Notified bodies’ involvement in the conformity assessment of low- and medium-risk devices (classes IIa and IIb, and class B and C) will be reduced (assessing the technical documentation of one representative device for a generic group of devices, for a category, or for an entire portfolio). Systematic assessment of the technical documentation of representative devices will not be required during surveillance activities. Sterile IVD class A devices will not require the involvement of a notified body. Notified bodies will have the option of replacing on-site audits with remote audits. Where justified by the absence of safety concerns, surveillance audits should be conducted only every two years. Unannounced audits should be conducted “for -cause.” The timeframes for consultations with authorities for medicinal products and SoHO (substances of human origin) are to be shortened [Article 52, Annex IX, Annex X, and Annex XI MDR; Article 48, Annex IX, Annex X, and Annex XI IVDR]. The scope of the CECP will be limited to class III implantable devices, with the Commission being empowered to add other device types by delegated act. The Performance Evaluation Consultation Procedure (PECP) will be removed. Instead, the possibility of obtaining early advice from expert panels will be introduced for class C and D IVD devices [Article 54 MDR; Article 48 and new Article 56a IVDR]. Fees for micro and small manufacturers and for orphan devices are to be reduced. The Commission is to be empowered to determine the level and structure of fees for notified bodies [Article 50 MDR].
Issue 5: Coordinating within a decentralized system
Coordination between competent authorities regarding product qualification and device classification (the “Helsinki procedure”) is to be codified, with the possibility of requesting opinions from expert panels [Article 4, new Article 4a, new Article 51a and new Article 51b MDR; Article 3, new Article 3a, new Article 47a and new Article 47b IVDR]. The assessment of applications from conformity assessment bodies and the designation/notification of notified bodies is to be streamlined with the participation of joint assessment teams consisting of the national authority responsible for notified bodies, experts appointed by the Commission, and experts appointed by other Member States. Joint assessment teams will be involved in the monitoring of notified bodies after their designation, at least every two years. The full re-assessment of notified bodies every five years will be deleted. The Commission will be empowered to determine the level and structure of fees and recoverable costs for the designation and monitoring of notified bodies [Article 36-44 MDR; Art. 31 IVDR]. The authority responsible for notified bodies will act as an “ombudsman” in the event of disputes between manufacturers and notified bodies [Art. 35 MDR; Art. 31 IVDR]. The obligation for notified bodies to participate in the notified body coordination group (NBCG-Med) is to be strengthened. NBCG-Med will report to the MDCG [Art. 49 MDR; Art. 31 IVDR]. The role of expert panels and their composition is to be expanded, involving them, among other things, in determining the regulatory status of products and device classification. Expert panels should be able to provide scientific, technical, clinical and regulatory advice to the Commission, Member States, the MDCG, notified bodies and, in some cases, manufacturers. The EMA will continue to provide the secretariat for the expert panels. The functions of expert panels and expert laboratories, currently regulated jointly in Article 106 of the MDR, will be clarified through a separate provision on expert laboratories [Article 106 and new Article 106a of the MDR; Article 100 of the IVDR]. The EMA will provide scientific, technical, and administrative support for coordination between national competent authorities in several areas, such as borderline cases and classification, multi-center clinical trials, derogations, vigilance, and market surveillance. The EMA will also provide support for SMEs [new Article 106b of the MDR].
Issue 6: relating to further digitalization
The EU declaration of conformity will be able to be provided digitally. Subject to future implementing rules, certain labeling information will be able to be provided digitally. Manufacturers of near-patient tests will be able to provide electronic instructions for use. Information under the MDR/IVDR will be submitted electronically. Economic operators must provide their digital contact in Eudamed [Article 19, new Article 110a, Annex I and Annex VI of the MDR; Article 17, new Article 103a, Annex I Annex VI of the IVDR]. Manufacturers will be able to produce technical documentation, reports, and other documents in digital form [new Article 52b of the MDR; new Article 48b of the IVDR]. For online sales, certain essential information necessary for device identification and instructions for use will have to be provided [Article 6 of the MDR; Article 6 of the IVDR]. The provisions on UDI assignment and registration in Eudamed are to be clarified. It is to be possible to create certain electronic systems outside the Eudamed database [Articles 27-33 and Annex VII of the MDR; Articles 24-30 and Annex VII of the IVDR].
Issue 7: On International Cooperation
A new section on international cooperation is to be introduced to promote activities aimed at global regulatory convergence and international cooperation, such as the International Medical Device Regulators Forum (IMDRF) and the Joint Medical Device Audit Programme (MDSAP) [new Article 108a and new Article 108b of the MDR].
Issue 8: Relationship to other EU regulations
For combined trials, the sponsor will be able to submit a single application, which will trigger a coordinated assessment under Regulation (EU) No 536/2014 on clinical trials, as amended accordingly by the Biotech Act (new Article 79a MDR; new Article 75a IVDR). Serious incidents reported under the vigilance system established under the MDR or IVDR that also qualify as actively exploited vulnerabilities (vulnerabilities) and serious incidents under Regulation (EU) 2024/2847 on cyber resilience will be shared with the relevant national computer security incident response teams (“CSIRTs”) and the European Union Agency for Cybersecurity (ENISA). In addition, manufacturers will be required to report actively exploited vulnerabilities and serious incidents that do not qualify as serious incidents under the MDR or IVDR to the CSIRT and ENISA via Eudamed. In Annex I of the MDR/IVDR, cybersecurity will be explicitly mentioned in the general security and performance requirements [new Art. 87a and Annex I of the MDR; new Art. 82a and Annex I of the IVDR].
At this stage, it’s difficult to discuss the specific implications of the changes, as they are still in their early stages. The proposal for these changes has only just been submitted by the Commission, meaning the European Parliament will now have to adopt them. Nevertheless, this article will attempt to summarize and generalize the changes described above. The main changes can be divided into four categories: governance, innovation, digitization, and coordination.
Administrative changes will be most noticeable for manufacturers. Primarily, many periods will be extended (certificate duration, audit period, etc.) and the frequency of certain procedures (such as audits) will be reduced. Some formal requirements have been abolished, primarily for established technologies and orphan devices. Rules for certain risk categories will also change. Manufacturers will have more time to submit certain reports, and audits will now be possible remotely. Reductions in individual fees will be crucial for small and micro-sized manufacturers. A loophole is also planned for member states in emergency situations, when derogations from marketing authorization procedures will be possible.
In the innovation category, the changes primarily concern certain simplifications in the certification process for breakthrough technologies. Additionally, fewer approvals by notifying bodies will be required and access to certain data categories will be broader. The Commission also plans to prioritize greater expert involvement, at various levels. A key element is the possibility for the Commission or Member States to establish regulatory sandboxes, which will allow for greater flexibility and freedom in the development of new technologies.
In the area of digitalization, the changes aren’t groundbreaking, but they are definitely necessary given the current market realities. Much information will now be able to be transmitted digitally, and the Eudamed platform will gain greater importance.
The final category is coordination between authorities. A certain duplication of procedures has been observed, resulting in excessive administrative burdens. Some procedures have been eliminated or standardized (now, one application can replace others). Using digital platforms, authorities will share more information, reducing the burden on producers. Another step is to strengthen the MDR-appointed authorities and international cooperation.
While the changes seem promising for manufacturers, for whom many mechanisms are to be simplified, it is currently difficult to draw concrete consequences from the changes. They appear to be broad-based and positive, aimed at developing the opportunities of the medical devices market in the European Union, which already employs over 930,000 people. It is important to ensure a space where innovation can flourish while ensuring equal safety. Nevertheless, the changes were proposed in December, so it will be crucial to monitor the next stages and the European Parliament’s views on the changes.
Sources
European Commission, ‘Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF 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 harmonization legislation referred to in its Annex I’ [2025] COM(2025) 1023 final
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC [2017]
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU [2017]
European Commission, ‘New measures to make the EU health sector more innovative, competitive and resilient’ (European Commission, 2025) <https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077> accessed 26/01/2026