The European Commission has proposed the most significant amendments to the EU Medical Device Regulation and In Vitro Diagnostic Regulation since their entry into force. These changes are intended to correct well-documented implementation challenges, reduce unnecessary regulatory burden, improve predictability and protect patient access, while maintaining high standards of safety and performance. For manufacturers, the proposals signal a shift toward a more proportionate and risk-based regulatory framework that better reflects real-world product lifecycles and innovation timelines. Understanding these proposals is essential for shaping future compliance strategies, certification planning and investment decisions.
A Shift Toward Proportionality
One of the most important themes in the proposed amendments is proportionality. The Commission has acknowledged that the current framework applies the same intensity of regulatory oversight to mature, low-risk technologies as it does to novel or higher-risk devices. The proposed reforms aim to correct this imbalance by aligning regulatory requirements more closely with risk, technological maturity and clinical history.
Key changes include simplification of Person Responsible for Regulatory Compliance requirements, particularly for small and medium-sized enterprises using external PRRC support. Rigid qualification and availability criteria are relaxed, improving access to regulatory expertise. The proposals also remove the fixed five-year certificate validity period, replacing it with risk-based periodic reviews conducted by notified bodies. This change reflects the reality that many mature technologies do not benefit from full recertification cycles and instead require proportionate surveillance. The introduction of a new category of well-established technology devices further supports this approach by recognising devices with a long history of safe use and subjecting them to lighter oversight. Certain reusable surgical instruments, accessories and software are also proposed for lower classification, reducing unnecessary certification burden. Together, these measures are intended to reduce duplication and allow regulatory oversight to focus where it adds the most value.
Reducing Administrative Burden
The Commission proposes to reduce the scope and validation requirements for Summary of Safety and Clinical Performance documents, particularly where information is already available through other channels. Periodic Safety Update Report frequency would be reduced and integrated into notified body surveillance activities rather than requiring separate submission cycles. Vigilance reporting timelines for non-critical incidents would be extended, allowing manufacturers to conduct more robust investigations before reporting. Clearer rules are also proposed for post-certification changes, including the use of agreed change control plans that reduce uncertainty and prevent unnecessary recertification. For IVDs, the authorisation process for low-risk performance studies would be simplified, reducing delays to research and development. These changes aim to free up regulatory capacity and allow quality teams to focus on meaningful risk management rather than administrative volume.
Supporting Innovation and Patient Access
A further pillar of the reform package is targeted flexibility to protect patient access and encourage innovation. The Commission recognises that certain patient groups, particularly those with rare diseases or unmet clinical needs, have been disproportionately affected by MDR and IVDR implementation challenges.
The proposals expand in-house device exemptions to include central laboratories and certain clinical trial uses, supporting hospital innovation and research. Priority and rolling review pathways are introduced for designated breakthrough and orphan devices, allowing evidence to be assessed progressively rather than in a single submission. New EU level tools are proposed to manage supply interruptions of critical devices, helping authorities intervene earlier when shortages arise. Derogation powers during public health emergencies would be broadened, allowing faster access to essential technologies. Regulatory sandboxes are introduced for emerging technologies, providing controlled environments for innovation. The reforms also include a long-term framework for reprocessing single-use devices and extend grandfathering provisions for legacy orphan devices beyond current transition deadlines. Collectively, these measures aim to ensure that regulatory requirements do not inadvertently restrict access to essential or innovative technologies.
Improving Predictability and Cost Efficiency of Certification
Certification unpredictability and cost escalation have been among the most significant concerns under MDR and IVDR. The proposed amendments seek to address these issues by improving transparency, consistency and efficiency in notified body interactions.
A formal structured dialogue mechanism is introduced to allow manufacturers and notified bodies to discuss regulatory expectations, evidence strategies and timelines earlier in the process. Notified body involvement would be reduced for lower-risk devices, with streamlined surveillance models and increased use of biennial reviews where justified. Remote audits would be more widely permitted, reducing operational burden. The scope of the Clinical Evaluation Consultation Procedure would be narrowed, limiting its use to cases where it provides clear added value. Fee reductions are proposed for small and medium-sized enterprises and orphan devices, alongside EU level oversight of fee structures to improve consistency across notified bodies. These measures aim to restore confidence in certification planning and support sustainable business models for manufacturers.
Strengthening Coordination Across the EU System
The EU regulatory system is decentralised, and divergent interpretations between notified bodies and competent authorities have created uncertainty. The proposed amendments strengthen coordination mechanisms to promote consistency.
The so called Helsinki procedure for borderline and classification decisions would be codified, providing a formal process for resolving disputes. Notified body designation and monitoring would be streamlined, improving oversight and consistency. A formal dispute resolution mechanism would be introduced, allowing manufacturers to challenge inconsistent decisions. Expert panels would have an expanded role, supported by the European Medicines Agency, and EMA involvement in cross-border coordination and SME support would be strengthened. These changes aim to reduce fragmentation and ensure that similar devices are treated consistently across the EU.
Accelerating Digitalisation
Digitalisation is embedded across the proposed reforms. The Commission proposes digital declarations of conformity, electronic labels and digital instructions for use where appropriate. MDR and IVDR submissions would become fully electronic, and clearer rules would apply to online sales of medical devices. Greater flexibility is introduced around UDI implementation and integration with EUDAMED. These measures reflect the realities of digital supply chains and modern healthcare delivery and are intended to reduce friction while maintaining traceability.
International Cooperation and Legislative Alignment
The proposed amendments also promote international regulatory convergence. Greater reliance on international frameworks such as IMDRF and MDSAP is encouraged, supporting more efficient global market access. The reforms improve alignment with other EU legislation, including the Clinical Trials Regulation through single submission pathways, the Cyber Resilience Act through explicit cybersecurity requirements and reporting pathways, and the Artificial Intelligence Act by repositioning MDR and IVDR within the relevant annex structure. This alignment is intended to reduce overlap and conflicting obligations across regulatory regimes.
What Manufacturers Should Do Now
Although the proposals are not yet adopted, manufacturers should begin assessing their potential impact. Pipeline products, certification strategies, clinical evidence plans and quality system resources may all be affected. Early analysis allows organisations to identify opportunities to reduce burden, optimise certification timing and adapt development strategies. Engagement with notified bodies and industry associations will also be important as the legislative process progresses.
LFH supports medical device and IVD manufacturers in interpreting regulatory change, adapting compliance strategies and planning certification under evolving EU frameworks. Our team helps organisations prepare for MDR and IVDR reform with clarity, proportionate strategy and practical implementation support.
FAQs – Proposed EU MDR and IVDR Changes
Are these MDR and IVDR changes already in force?
No, they are proposed amendments and must still go through the EU legislative process before adoption.
Will existing certificates automatically benefit from the new rules?
This will depend on the final adopted text and transitional provisions.
Do the changes reduce patient safety requirements?
No, the stated aim is to maintain high safety standards while reducing unnecessary burden.
Will SMEs benefit more than large manufacturers?
Many measures are specifically designed to support SMEs, but benefits apply across the sector.
Should manufacturers change their compliance strategy now?
Manufacturers should assess potential impacts but wait for final legislative text before making irreversible changes.
