The European Commission has recently published its long-anticipated proposal to revise the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). This significant proposal does not overhaul the existing framework but represents a substantial optimization aimed at “simplification” and “reducing burden.” Its core logic shifts decisively from rigid, one-size-fits-all requirements towards a risk-based, proportional approach to regulation. This directly addresses structural challenges exposed during the current regulations’ implementation: excessively high costs, complex processes, and stifled innovation.
The breadth and depth of this revision exceed expectations, covering the entire product lifecycle from clinical evidence requirements to market surveillance. The following outlines the most critical substantive changes based on the proposal text.
I. Core Philosophy: From “One-Size-Fits-All” to “Proportionality” and “Simplification”
The revision is guided by two central principles:
- Proportionality: The stringency of regulatory requirements should correspond to the actual risk of the device, the size of the company (with special consideration for SMEs), and the maturity of the technology.
- Simplification: Eliminating redundant processes, reducing administrative burdens, promoting digitalization to make rules clearer and easier to implement.
II. Detailed Explanation of Core Revisions
1. Conformity Assessment & Certificate Management: Dynamic Surveillance Replaces Fixed Cycles
- Removal of the 5-Year Certificate Validity Period (Major Change): This is the most symbolic change. The proposal deletes the maximum five-year validity period for certificates stipulated in MDR Article 56 and IVDR Article 51. In its place, Notified Bodies will implement proportional, risk-based periodic surveillance reviews based on the device’s risk class. This shifts the regulatory focus from fixed administrative renewals to the dynamic tracking of ongoing compliance, greatly enhancing management flexibility.
- Simplified Conformity Assessment Procedures:
- Reduced Technical Documentation Review: For low-risk (Class IIa) and medium-risk (Class IIb) devices, Notified Bodies will not be required to review every single device type. Instead, they can perform assessments based on representative sampling of devices, significantly easing the burden for manufacturers, especially those with large portfolios.
- New Pathway for “Mature Technology Devices”: The proposal introduces the concept of “mature technology devices.” For devices with a long history of safe use and stable design, a simplified conformity assessment and clinical evidence pathway will apply, replacing the rigid listing approach of the original regulations.
2. Company Obligations & Personnel Requirements: Significant Burden Reduction
- Relaxed Requirements for the Person Responsible for Regulatory Compliance (PRRC):
- Simplified Qualification Criteria: The detailed list of academic and professional experience requirements for PRRCs is removed, requiring only that they possess the “necessary expertise in the field of medical devices.”
- Reduced Availability Requirement: For SMEs relying on an external PRRC, the strict requirement for the PRRC to be “permanently and continuously” available is replaced with a more flexible “available” requirement. This is one of the most direct relief measures for SMEs.
- More Flexible Clinical Evidence Requirements:
- Broader Data Sources: Explicitly allows the use of clinical data from published scientific literature, even if not peer-reviewed, as part of the clinical evidence.
- Emphasis on Non-Clinical Data: Encourages the use of “New Approach Methodologies (NAMs)” such as computer modeling (in silico) and in vitro testing to partially replace or supplement clinical data, especially for low-risk or mature technology devices.
- Simplified Post-Market Clinical Follow-up (PMCF): Allows PMCF results to be directly updated in the Clinical Evaluation Report, eliminating the need for a separate PMCF evaluation report.
3. Supporting Innovation & Special Needs: Establishing New Pathways for New Challenges
- Establishing a “Breakthrough Device” Pathway: Creates a priority pathway for devices representing a major innovation in treating, diagnosing, or preventing life-threatening or debilitating conditions. Benefits include early scientific consultation with expert panels and rolling reviews to accelerate market access.
- Creating an “Orphan Device” Pathway: Provides incentives such as fee reductions and extended transitional periods for devices intended for rare diseases or very small patient populations (affecting no more than 12,000 people annually in the EU). This aims to ensure these crucial products do not disappear from the market.
- Introducing “Regulatory Sandboxes”: Allows Member States or the EU to establish controlled testing environments where, under strict safety conditions, certain regulatory requirements can be temporarily waived for disruptive technologies and innovative products, facilitating learning for future regulation.
4. Regulatory Harmonization & Digitalization: Enhancing Efficiency and Consistency
- Strengthening EU-Level Coordination:
- Expanding the role of Expert Panels to provide advice on a wider range of areas, including product classification and regulatory status determination.
- Empowering the European Medicines Agency (EMA) with greater coordination functions among national competent authorities and providing scientific support.
- Comprehensive Push for Digitalization:
- Explicitly allowing technical documentation, declarations of conformity, and other documents to be submitted and maintained in electronic form.
- Encouraging the use of digital labels and electronic instructions for use (eIFU).
- Improving the functionality and interconnectivity of the EUDAMED database to enhance transparency and regulatory efficiency.
5. Other Important Adjustments
- Classification Rule Adjustments: Revisions to classification rules for certain devices (e.g., reusable surgical instruments, accessories for active implantable devices, some software) may lead to a lower risk class, subjecting them to simpler conformity assessment procedures.
- Simplified Post-Market Surveillance (PMS) Reporting: Reduces the frequency of Periodic Safety Update Reports (PSUR) and better aligns them with regulatory activities.
- Clarifying Interface with the AI Act: MDR/IVDR are moved from Annex I, Section A to Section B of the AI Act. This means high-risk AI medical devices complying with MDR/IVDR will primarily adhere to the cybersecurity and requirements of MDR/IVDR, avoiding double regulatory burden.
III. Impact and Recommendations for Manufacturers (Especially SMEs)
Short Term (Immediate Actions):
- Reassess PRRC Strategy: SMEs should review internal or external PRRC arrangements for compliance with the new “availability” requirement.
- Communicate with Notified Bodies: Understand their plans for implementing risk-based periodic reviews and prepare for future surveillance audits.
- Review Product Portfolio: Assess if any products qualify as “mature technology devices” or benefit from adjusted classification rules.
Medium to Long Term (Strategic Planning):
- Build a Continuous Compliance System: Shift from “preparing for recertification” to establishing a system for continuously generating safety and performance data to meet dynamic surveillance.
- Evaluate Eligibility for Innovation Pathways: If a product has breakthrough potential or is intended for small populations, research and plan to utilize the new “breakthrough device” or “orphan device” pathways.
- Embrace Digitalization: Invest in electronic document management systems to prepare for full digital submission readiness.
IV. Conclusion
This revision proposal represents the EU’s profound reflection on and decisive correction of the lessons learned from several years of MDR/IVDR implementation. Through a series of pragmatic and flexible measures, it directly targets the most criticized pain points in the current regulatory system. If adopted, it will significantly reduce compliance costs for the medical device industry (the proposal estimates over €3 billion in annual burden reduction), enhance regulatory predictability, and inject strong momentum into medical technology innovation. For all medical device companies operating in the EU market, this marks the dawn of a new regulatory era, requiring proactive strategy adjustments to adapt to a profound shift: from “static compliance” to “dynamic compliance,” and from “risk prevention” to “balanced risk management and innovation encouragement.”
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