Commission publishes a Proposal for a Regulation to simplify MDR and IVDR

On 16 December 2025, the European Commission published a proposal for a Regulation to reduce and simplify rules on medical and in vitro diagnostic devices. The proposed text includes significant changes to the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (MDR and IVDR).

The Proposal addresses different points raised in a recent targeted evaluation. The Commission text presents different amendments divided by topic:

Simplification and proportionality

• PRRC requirements (MDR and IVDR). Removal of the detailed qualification requirements for the PRRC and removal of the obligation that SMEs to have the PRRC “permanently and continously” available, but only available.
• Certificate validity (MDR and IVDR). The maximum period of validity of certificates (currently 5 years) is removed. Notified bodies will carry out periodic reviews proportionate to the device’s risk.
• Demonstration of equivalence for clinical data (MDR and IVDR). The conditions for relying on clinical data of an equivalent device are made more flexible.
• Well-established technologies (MDR). A definition of ‘well-established technology device’ is introduced for devices which will be subject to more proportionate requirements.
• Repackaging and relabelling (MDR & IVDR). The requirements for a notified body certificate for relabelling and repackaging activities, as well as the prior notice obligation, are removed.
• Classification rules (MDR). Some classification rules are adapted. Certain devices will fall under lower risk classes, e.g., reusable surgical instruments, accessories to active implantable devices, and software.

Reduction of administrative burden

• Summary of safety and clinical performance (MDR and IVDR). Manufacturers must provide a summary of safety and (clinical) performance only for those devices for which the notified body must conduct a technical documentation assessment.
• Periodic Safety Update Report (MDR and IVDR). The frequency to update PSUR is reduced. Additionally, the review of the PSUR by the notified body will be part of its surveillance activities.
• Reporting timeline of certain serious incidents in the framework of vigilance (MDR and IVDR). The timeline for manufacturers to report serious incidents (not related to public health threats, death or serious deterioration of health) is prolonged from 15 days to 30 days.
• Changes after certification (MDR and IVDR). Notified bodies must distinguish between changes regarding the quality management system or the approved device that manufacturers can implement without prior notification or approval.
• Authorisation or notification of certain performance studies (IVDR). Performance studies involving only routine blood draws will not require a prior authorisation. In addition, the notification of performance studies on companion diagnostics using left-over specimens will be removed.

Innovation and availability of devices for special patient groups or situations

• In-house devices (MDR and IVDR). The conditions for the manufacturer and the use within health institutions will become more flexible. Additionally, the condition that there is no equivalent device on the market is removed. Central laboratories manufacturing and using tests exclusively for clinical trials will also be part of the in-house device exemption.
• Interruption or discontinuation of supply of certain devices (MDR and IVDR). A central IT system for reporting and information exchange will be made available through EUDAMED or via systems interoperable with EUDAMED. EMA will develop a methodology to identify devices subject to the reporting obligation and will compile a list of those devices.
• Conformity assessment procedures for breakthrough devices or orphan devices (MDR and IVDR). Criteria for the designation of breakthrough and orphan devices are introduced. Manufacturers will have access to expert panel advice.
• Derogations for public health emergencies, disasters or crises (MDR and IVDR). In cases of public health emergencies, the Commission may initiate authorisation for the placing of devices on the market.
• Regulatory sandboxes (MDR and IVDR). Member States and the Commission may establish regulatory sandboxes to address the needs of emerging technologies.
• Reprocessing of single-use devices (MDR). Manufacturers will be required to justify any claim that a device is for single use. Any person who fully refurbishes a single-use device will be considered the manufacturer of the refurbished device.
• Kits (IVDR). Clarification regarding the composition of kits.
• “Grandfathering” of legacy orphan devices (MDR and IVDR). Orphan devices CE-marked in accordance with the former Directives may continue to be placed on the market after the expiry of the transitional periods (subject to conditions).
• Nanomaterial (MDR). The outdated nanomaterial definition in Article 2 MDR will be deleted and replaced.

Predictability and cost-efficiency of certification

• Structured dialogue (MDR and IVDR). A legal basis will be introduced for structured dialogue between notified bodies and manufacturers, both before and after submission, in accordance with documented procedures.
• Conformity assessment procedures (MDR and IVDR). The role of notified bodies in the conformity assessment of lower- and medium-risk devices (Classes IIa and IIb, and Classes B and C) will be streamlined. Systematic assessment of representative devices during surveillance activities will no longer be required. Class A sterile IVDs will not require the involvement of notified bodies. Notified bodies may replace on-site audits with remote audits where appropriate. Where justified by the absence of safety concerns, surveillance audits should be carried out every two years. Unannounced audits will be conducted only on a for-cause basis. Timelines for consultation with medicinal product and substances of human origin (SoHO) authorities will be shortened.
• Clinical evaluation consultation procedure (MDR) and performance evaluation consultation procedure and early advice (IVDR). The scope of the CECP will be restricted to Class III implantable devices. The PECP will be discontinued, and a mechanism for early advice from expert panels for Class C and D IVDs will be introduced.
• Notified body fees (MDR). Reduced fees will apply to micro and small manufacturers and orphan devices.

Coordination within decentralised system

• Regulatory status of products and classification of devices (MDR and IVDR). The coordination of product qualification and device classification (‘Helsinki procedure’) will be codified, with expert panel opinions available on request.
• Designation and monitoring of notified bodies (MDR and IVDR). The assessment and designation of notified bodies will be streamlined through joint assessments and notified bodies will be monitored at least every two years. Full reassessments every five years will be removed.
• Dispute resolution mechanism between manufacturers and notified bodies (MDR and IVDR). The authority for notified bodies will act as an “ombudsperson” in disputes with manufacturers.
• Coordination of notified bodies (MDR and IVDR). Notified bodies’ participation in the NBCG-Med will be reinforced, and the group will report to the MDCG.
• Enhanced role of external expertise available to the regulatory system (MDR and IVDR). Expert panels’ role and composition will expand to cover, among others, regulatory status and device classification, providing advice to authorities, notified bodies, and in certain cases manufacturers. EMA will remain their secretariat.
• Support from the EMA for the coordination of competent authorities (MDR). The EMA will provide technical and administrative support to national authorities and SMEs across classification, clinical studies, derogations, vigilance, and market surveillance.

Further digitalisation

• Digitalisation of compliance tools (MDR and IVDR). The EU declaration of conformity, certain label information, and instructions for near-patient tests may be provided digitally. Submissions must be electronic, and economic operators must provide digital contact details in EUDAMED.
• Digitalisation of conformity assessment (MDR and IVDR). Manufacturers may draw up technical documentation, reports, and other documents in digital form.
• Online sales (MDR and IVDR). Essential device information and instructions are required for online sales.
• UDI and EUDAMED (MDR and IVDR). UDI assignment and EUDAMED registration provisions have been clarified, allowing certain electronic systems to operate outside EUDAMED.

International cooperation

• International cooperation and reliance mechanisms (MDR). A new section promotes international cooperation and regulatory convergence, including initiatives like IMDRF and MDSAP.

Interplay with other Union legislation

• Combined studies involving medicinal products, medical devices and/or IVDs (MDR and IVDR). Sponsors of combined studies can submit one application for coordinated assessment under the amended clinical trials regulation (amended by the Biotech Act accordingly).
• Cybersecurity (MDR). Serious incidents that are also actively exploited vulnerabilities or severe cyber incidents will be shared with national CSIRTs and ENISA. Manufacturers must also report vulnerabilities and severe incidents not classified as serious under MDR/IVDR to CSIRTs and ENISA via EUDAMED. Cybersecurity will be explicitly included in Annex I general safety and performance requirements.

Other amendments

• EMA’s secretariat role for expert panels is aligned with the MDR’s updated provisions on expert panels.
• In Annex I to the Artificial Intelligence Act, the MDR and IVDR are moved from Section A to Section B.

For any questions on compliance of medical devices, contact MDlaw Team here or at mdlaw@obelis.net.