On 16 December 2025, the European Commission published its proposal to simplify the EU’s Medical Devices Regulation (Regulation (EU) 2017/745) (MDR) and In Vitro Diagnostics Regulation (Regulation (EU) 2017/746) (IVDR). The proposal aims to simplify EU rules for the MedTech industry, support digitalization of regulatory procedures, harmonize divergent practices via strengthened cooperation, and speed up access by introducing timelines to complete conformity assessments. Finally, the proposal also intends to provide clarity on the rules applicable to devices incorporating Artificial Intelligence (AI).
In more detail
The key points of the Commission’s proposal are listed below, categorized by overarching topics. The measures apply to both the MDR and IVDR, unless otherwise specified.
Measures for simplification and reduction of administrative burden:
- Changes to MDR classification widening lower risk classes: Some of the MDR’s classification rules would be adapted resulting in lower risk classes for certain devices, such as reusable surgical instruments, accessories to active implantable devices and software. The key benefit for devices falling into lower class would be that notified body (NB) assessment would no longer be required. Notably, Rule 11 of Annex VII, which has so far resulted in most medical software, including most patient self-management apps, being classified as Class IIa, would allow classification as Class I, thereby relieving manufacturers of the obligation to involve a notified body in the conformity assessment. However, the proposal introduces intended use in “serious” or “critical” situations as a new criterion triggering classification as Class IIa, IIb, or III. There will be (too much) room for interpretation, and MDCG might not inject clarity in the future.
- Easier requirements for person responsible for regulatory compliance (PRRC): The proposal would remove detailed qualification requirements for the PRRC. Further, SMEs relying on an external PRRC, would no longer need to have the PRRC ‘permanently and continuously’ available, but only available. Unfortunately, for non-SME manufacturers, the requirement to have a PRRC “within their organization” is not waived; therefore, pursuant to MDCG 2019-07, the PRRC must be an employee of the manufacturer. By contrast, in the pharmaceutical sector, the “employee” requirement does not apply to Qualified Persons for Pharmacovigilance (QPPVs) or Qualified Persons (QPs) for GMP, who may be retained as third-party consultants. Alignment with the pharmaceutical regulatory framework would have been preferable.
- Indefinite certificate validity with risk-based recertification. The maximum 5 year validity of certificates would be removed. This has been one of the key demands raised in the 2023 White Paper developed by medtech industry associations, spearheaded by the German BVMed. In particular, the paper calls for changes to the five-year re-certification requirement. NBs would adopt a risk-based approach and carry out periodic reviews proportionate to the risks. It would need to be determined (by the MDCG?) what frequency exactly corresponds to a “periodic” review and what scope such reviews should have. One option could be to incorporate these reviews into the annual QMS surveillance audit and to encourage remote reviews, in parallel with the “remote audits” also envisaged in the proposal.
- Broader clinical evidence definition: More information would qualify as clinical data, including any studies (whether a clinical investigation or not) published in scientific literature, and other clinical experience published in peer-reviewed scientific literature. The conditions for relying on clinical data of equivalent devices are also made more flexible. Medical device safety and performance could be based on non-clinical testing methods, including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modeling or simulation and pre-clinical evaluation. The use of ‘New Approach Methodologies’ (NAM), such as in silico testing, is promoted. Notably, the concept of NAM, including in silico testing, appears promising. Pursuant to Recital (38), NAM is not limited to replacing animal testing but may also be extended to clinical evaluations, such that RWD (real-world data) used to power AI models could at least contribute to data generated through conventional clinical investigations and supplement literature-based evaluations of equivalent devices.
- Simpler rules for well-established technology devices: The proposed definition of ‘well-established technology device’ (new Art. 2(72) MDR) leaves room for interpretation when offering criteria such as “generic”, “simple”, “stable”, “long history”, “well-known”. Another challenge for MDCG, which would hopefully not overcomplicate the definition. Among the various simplifications, manufacturers of Class IIa implantable and Class III devices would be relieved of the obligation to draw up a Summary of Safety and Clinical Performance. Another example is the removal of the notified body review of the PSUR for Class III and Class IIb implantable devices where these qualify as well-established technologies. Overall, the relaxation of the rules could have been more far-reaching.
- More flexible repackaging and relabeling: NB certificate for relabeling and repackaging activities would no longer be required. For parallel traders the obligation to notify the original manufacturer at least 28 day prior to launch would be removed as well.
- Reduced scope for summary of safety and (clinical) performance (SS(C)P): The scope of devices for which an SS(C)P must be provided is reduced to those for which the NB must conduct a technical documentation assessment.
- Less frequent Periodic Safety Update Report (PSUR): The frequency according to which manufacturers are obliged to update PSURs is reduced (Classes III, IIb, C and D would need to update after the 1st year and then every 2 years or if there is a significant change, while Class IIa would need to update when necessary). The review of the PSUR by the NB will be part of its surveillance activities where applicable.
- Longer timeline for non-critical serious incident vigilance reporting: Manufacturers would have 30 days (instead of 15 days) for reporting serious incidents which are not related to public health threats, death or serious deterioration of health.
- Changes after certification: NBs must differentiate between changes to quality management systems (QMS) and devices (i) without prior notification, (ii) without prior approval, (iii) only after approval. Where appropriate, the NB and manufacturer should agree on a change control plan. This proposed amendment affects Annex VII, i.e. the requirements to be met by NBs. For actually relaxing the standards applicable to the rating of changes or modifications (substantial, significant), NBs would have to first incorporate, or update, according definitions, rules, protocols set out in their SOPs and/or their (usually general terms-based) certification agreements entered into with manufacturers. Thus, there might be a time lag until the regime applicable to post-certification changes will actually be eased. If the EU proposal signed into law, manufacturer might proactively request relaxed standards when dealing with changes.
- No authorization needed for certain IVDR performance studies: Performance studies involving only routine blood draws will not be subject to prior authorisation. The notification of performance studies on companion diagnostics using left-over specimens will be removed.
Innovation and availability:
- Rules favoring access to breakthrough and orphan devices: Criteria for breakthrough devices (high degree of novelty, with significant positive clinical impact, for a life-threatening or irreversibly debilitating disease or condition, compared to alternatives or fulfilling an unmet medical need) and orphan devices (disease or condition that presents in not more than 12 000 individuals in the EU per year, with insufficient available alternatives or clinical benefit to available alternatives) would be introduced. These devices be designated by an expert panel. Breakthrough devices and orphan devices would be subject to a priority and rolling review.
- ‘Grandfathering’ of legacy orphan devices: 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.
- Emergency derogations to ensure access: In case of a public health emergencies, the Commission could authorise devices on its own initiative. During serious cross-border health threats, disasters or crises. competent authorities could authorize derogations from manufacturing, design or intended purpose of CE-marked devices.
- Updated nanomaterial definition in the MDR: The MDR’s current nanomaterial definition would be replaced by a reference to the Commission Recommendation of 10 June 2022 on the definition of nanomaterial.
- Regulatory sandboxes supporting emerging technologies: Member States and the Commission may establish regulatory sandboxes to address needs of emerging technologies.
- Reprocessing of single-use MDR devices: 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. This provision would only become applicable 5 years after entry into force.
- Clarification on IVDR kits: The proposal would clarify that kits under the IVDR may contain IVDR devices and their accessories (which may or may not be CE-marked) and MDR devices and their CE-marked accessories, as well as other products which are used within the in vitro diagnostic examination or the presence of which in the kit is otherwise justified, and where those products are in conformity with the Union legislation that applies to them.
- Broader in-house device exception: The conditions for the manufacture and use within healthcare institutions are made more flexible, e.g. allowing their transfer if this is in the interest of patient safety or public health). Under the IVDR, the condition that there is no equivalent device on the market would be removed. Central laboratories manufacturing and using tests exclusively for clinical trials are added to the scope of the in-house device exemption.
- Handling supply interruptions or discontinuations: A central IT tool for reporting and information exchange on supply interruptions or discontinuations would be provided in EUDAMED. EMA will develop a methodology to identify and list devices falling within the scope of the reporting obligation.
Digitalization measures:
- Digitalization of regulatory documents: The EU declaration of conformity could be provided in digital form. Subject to future implementing rules, certain information on the label could also be provided in digital form. Manufacturers of near-patient tests could provide electronic instructions for use (eIFU). The submission of information pursuant to MDR/IVDR shall be performed electronically. Economic operators need to provide their digital contact in EUDAMED.
- Conformity assessment digitalization: Manufacturers could draw up technical documentation, report and other documents in digital form.
- Mandatory information for online sales: Certain essential information necessary to identify the device and the instructions for use would have to be provided in case of online sales.
- UDI and EUDAMEND clarification: The provisions on UDI assignment and registration in EUDAMED would be clarified, further, certain electronic systems could be set up outside EUDAMED.
Coherent framework, predictability and cost-efficiency of certification:
- Structured dialogue: A legal basis for NBs and manufacturers to conduct, pre- and post-submission, a structured dialogue based on documented procedures would be introduced.
- Changes to conformity assessment procedure for reduced NB involvement and faster certification: The involvement of NBs in the conformity assessment classes IIa, IIb, B and C would be reduced (technical documentation assessment of one representative device for a generic device group, for a category or for the entire portfolio). No systematic technical documentation assessment of representative devices would be required during surveillance activities. Class A sterile IVD would not require NB involvement.
- Remote NB audit option, less NB audits overall: NBs could replace on-site audits by remote audits. Where justified due to absence of safety issues, surveillance audits should be conducted only every two years. Unannounced audits should be conducted ‘for-cause’.
- Changes to clinical evaluation consultation procedure (CECP) and performance evaluation consultation procedure (PECP): CECP scope limited to class III implantable devices, but the Commission could add other types of devices by delegated act. PECP will be removed. Instead, early advice could be received from expert panels.
- MDR NB fee reductions: Fee reductions for micro (50%) and small (25%) manufacturers and for orphan devices (50%). The Commission would be empowered to set level and structure of NB fees.
Strengthened cooperation and interplay with other EU legislation:
- Regulatory status and classification of devices The coordination among competent authorities regarding the qualification of a product and the classification of a device (‘Helsinki procedure’) would be codified, with the possibility to request opinions from expert panels. If no substantiated disagreement is raised by any Member State, the competent authority would adopt its decision on classification within 90 days after receiving the classification dispute referred by the manufacturer or NB.
- A stronger role for the European Medicines Agency (EMA): The EMA would provide scientific, technical and administrative support for the coordination among national competent authorities in several areas, such as borderline and classification, multi-country clinical studies, derogations, vigilance and market surveillance. EMA would also provide support to SMEs. The EMA would also monitor shortages of medical devices, and a list of critical devices would be created.
- Designation and monitoring of NBs: The assessment of applications from conformity assessment bodies and the designation/notification of NBs would be streamlined with the involvement of joint assessment teams. Joint assessment teams would be involved in the monitoring of NBs after they have been designated, at least every two years. The full reassessment of NBs every 5 years would be removed.
- Coordination of NBs under the MDR: NBs would have to participate in the NBs coordination group (NBCG-Med), which would report to the Medical Devices Coordination Group.
- Strengthened expert panels: The role of expert panels and their composition would be broadened, involving them e.g. in determination of the regulatory status of products and classification of devices. In certain cases, expert panels should be able to provide scientific, technical, clinical and regulatory to manufacturers.
- Dispute resolution between manufacturers and NBs: The authority responsible for NBs will have an ‘ombudsperson’ role in case of disputes between manufacturers and NBs. This ombudsperson would hear and decide upon the case within 90 days.
- Combined studies involving medicinal products: For combined studies, the sponsor may submit a single application, triggering a coordinated assessment, in accordance with the Clinical Trials Regulation (Regulation (EU) No 536/2014).
- Cybersecurity incident reporting: Serious incidents reported in accordance with the vigilance system established under the MDR or IVDR, which also qualify as actively exploited vulnerabilities and severe incidents as referred to in Regulation (EU) 2024/2847 on cyber-resilience, will be made available to the relevant national response teams (CSIRTs) and to the ENISA (EU Agency for Cybersecurity). In addition, manufacturers will have to report actively exploited vulnerabilities and severe incidents that do not qualify as serious incidents within the MDR or IVDR to the CSIRTs and ENISA through EUDAMED.
Amendment impacting devices incorporating AI:
- The classification changes impacting medical device software (MDSW) could result in the device incorporating AI no longer being classified as a high risk AI under Regulation (EU) 2024/1689 on artificial intelligence (EU AI Act).
- The EU AI Act would be amended so that the MDR and IVDR would be placed in Section B of Annex I instead of the current Section A of Annex I.
Context
The current revision of the MDR and IVDR were called for by the EP on 23 October 2024 in its decision on the urgent need to revise the medical devices regulation. The EP cited, among others, difficulties reported by various stakeholders (in particular small and medium-sized manufacturers, NBs and healthcare providers), which could ultimately lead to unavailability of life-saving devices despite the EU’s best intentions to ensure a high level of patient safety.
Further to the EP’s decision, the Commission launched a public consultation on the MDR and IVDR this Spring, then called for evidence for the targeted revision of the regulations this Fall. Both initiatives garnered significant stakeholder interest, with 584 feedback entries in the public consultation, and 441 in the call for evidence.
The Commission’s proposal now seeks to answer the feedback received, balancing on the thin edge of ensuring a high level of safety and health while still supporting innovation, EU competitiveness, as well as avoiding device shortages and delays caused by regulatory bottlenecks due to the legislative complexity.
In its statement, MedTech Europe already welcomed the proposal as a key milestone for fixing the stakeholders concerns with the MDR and IVDR.
What comes next?
The legislative proposal for simplification of the MDR and IVDR Regulations will now be submitted to the European Parliament (EP) and the Council for adoption.
Once adopted by the EP and the Council, most MDR and IVDR simplifications would apply 6 months after entry into force, where the entry into force is the 20th day after publication in the Official Journal.
The Commission expects adoption by the co-legislators by Q2 2027, and provisions may be subject to change during the legislative procedure. Therefore, while the consensus is that the Commission proposal is an important milestone towards a more industry-friendly medical device regulatory framework in the EU, however, the MedTech industry will have to wait some time for actual relief from the current complex rules.
In the meantime, we will continue to monitor the proposal to simplify the MDR and IVDR, and report on major milestones, in particular, when the public consultation is launched on this initiative, enabling the industry to give feedback on how well the Commission responded to the raised concerns, including if further measures are needed.
Meanwhile: harmonized practice and timelines of notified bodies on the horizon
Prior to the proposal, on 12 December 2025, the Commission also published its draft Implementing Regulation on quality management and procedural requirements for Notified Body conformity assessment activities. While not formally part of the initiative to simplify the MDR and IVDR, however, the draft Implementing Regulation fits into the Commission’s overall goals to provide a more predictable regulatory framework for the MedTech Industry.
The draft Implementing Regulation would:
- specify (and thus limit) the information that NBs must request before quotation, as well as the minimum contents of their quotations;
- set maximum timelines for conformity assessment activities (a total of 255 days, or, if the NB can run the QMS auditing and product verification in parallel, only 165 days) and assessments of a planned substantial changes (a total of 135 days, unless a new conformity assessment is necessary);
- set the rules and maximum times of interruption (clock stops) of conformity assessment activities where additional input is needed from the manufacturer;
- specify the documentation that NBs must request from manufacturers for re-certification, and set a maximum 60 days timeline for reviewing this documentation.
- set a maximum 60 days timeline for verifying the QMS re-certification applications;
- set a maximum 15 days timeline for re-issuing certificates after a positive decision.
Th Commission plans to adopt this draft Implementing Regulation by Q1 2026, planning a gradual application from 3 months after entry into effect for most provisions, up to 1 January 2028 for others. The Commission accepts stakeholder feedback on the draft Implementing Regulation until 23 January 2026.
