3. Structured Dialogue & the “Ombudsperson” Role


To solve the chronic bottleneck crisis, the revisions formalize “structured dialogue” and introduce an “ombudsperson” mechanism to resolve disputes between manufacturers and notified bodies.1,5 body will act as ombudsperson, with disputes to be resolved within 90 days5


:


• Insight: Structured dialogue is an exercise in transparency; RQM+ coaches your teams to use these sessions to identify red flags early, building the professional credibility that prevents costly review loops and misunderstanding of product risks


4. Clinical Evidence Strategy: Navigating the “Post-Market Tax”


The proposal expands the possibility of demonstrating safety using non-clinical data alone, including in silico testing, computational modeling, and simulation.1,4 call a “post-market tax”:


While this significantly lowers the barrier for initial market entry, it creates what we


• The executive reality: Initial flexibility must be balanced by a robust post-market clinical follow-up (PMCF) strategy; as a global partner, RQM+ specializes in engineering these hybrid evidence models, helping you capture the real-world data needed to maintain approval once your device is in widespread clinical use


5. Operational Agility: Change Control Plans and PRRC Flexibility Beyond clinical data, the proposed revisions provide significant operational relief for the entire product life cycle:


• Change control plans: The proposal requires notified bodies to distinguish between changes that manufacturers can implement without prior notification, without prior approval, or only after approval;1


where appropriate, the NB and


manufacturer may agree on a predetermined change control plan. Under such a plan, the manufacturer and NB agree upfront on the scope of a planned change, the implementation approach, the associated risks, the risk controls, and the specific verification and validation activities required. Changes executed in accordance with the agreed plan do not require a new regulatory review, but any deviation from the plan would render the change unauthorized⁴


• PRRC flexibility: The requirement for a Person Responsible for Regulatory Compliance (PRRC) to be “permanently and continuously available” has been eased for SMEs, moving toward a more practical contractual model1,4


EU MDR/IVDR Targeted Revisions: The Executive Mandate The COM(2025) 1023 proposal is currently in its consultation phase, with adoption expected by the European Parliament and Council around Q2 2027.1,4


Executives should not wait for the ink to dry on the final legislation.


The single most important action today is to identify the specific pipeline pain points that these proposals are intended to solve, whether in clinical evidence strategy, change management, software classification, or post-market surveillance. By engaging in the consultation process and tracking these changes through a global lens, you can ensure your organization is positioned to lead, rather than react.


As external oversight becomes more risk-proportionate, strategic expertise becomes more valuable. RQM+ provides the regulatory and clinical guidance to help you adapt to these changes with confidence.


References 1


European Commission. (2025). Proposal for a Regulation of the European Parliament and of the Council on medical devices and in vitro diagnostic medical devices as regards a targeted revision. COM(2025) 1023 final. https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf


2 3


MedTech Dive. (2025, December 19). EU proposal would simplify Medical Device Regulation. https://www.medtechdive.com/news/eu-proposal-simplify-mdr/808398/ Team-NB. (2026, March 2). Position Paper: MDR/IVDR revision: impact on the sector. https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-


revision-impact-on-the-sector-20260302.pdf


4 RAPS. (2026, January). EU ofcials detail proposed MDR, IVDR revisions. https://www.raps.org/news-and-articles/news-articles/2026/1/eu-ofcials-detail-proposed-mdr,-ivdr-revisions 5


Arnold & Porter. (2026, February). The EU Medical Device Shake-Up: What International Companies Should Prepare For. https://www.arnoldporter.com/en/perspectives/ advisories/2026/02/the-eu-medical-device-shake-up


The authority responsible for each notified


RQMplus.com


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