Why the European Commission initiated a broad MDR and IVDR reform
The first years of MDR and IVDR application revealed a clear tension between the high level of regulatory ambition and the practical operability of the system. While the regulations undeniably strengthened patient safety, transparency, and lifecycle oversight, their implementation exposed structural bottlenecks. Limited notified body capacity, diverging interpretations across Member States, and an increased documentation burden resulted in certification delays, market withdrawals of legacy devices, and reduced innovation capacity.
The proposed reform should therefore be understood as an effort to restore proportionality and system functionality without compromising the core objectives of MDR and IVDR.
Nature of the changes – a structural adjustment rather than a philosophical shift
The Commission’s proposal does not challenge the fundamental pillars of the EU medical device framework, including lifecycle responsibility of manufacturers, evidence-based conformity assessment, and the central role of post-market surveillance. Instead, it introduces targeted structural adjustments aimed at improving implementation, enhancing predictability, and reinforcing the risk-based approach.
A key objective is to align regulatory scrutiny more closely with device risk and technological maturity.
Key MDR and IVDR changes – an overview of the main regulatory adjustments
The reform proposal introduces a broad set of amendments, including the following key elements:
- Formal legal recognition of structured dialogue between manufacturers and notified bodies during conformity assessment.
- Reduced notified body scrutiny for low-risk devices and well-established technologies.
- Stronger recognition of post-market data as an integral component of the overall evidence strategy.
- Simplified requirements for demonstrating clinical equivalence.
- Simplified requirements for equivalence in biocompatibility assessments.
- Removal of Article 82 MDR, clarifying the framework for clinical investigations conducted outside the EU.
- Improved alignment between MDR/IVDR provisions and MDCG guidance documents.
- Reduced regulatory burden for devices with a long history of safe use.
- Clear confirmation that clinical investigations remain the standard for implantable devices and Class III devices.
- Removal of the Performance Evaluation Consultation Procedure under IVDR.
- Simplified requirements for performance studies of low-risk IVDs.
- Streamlined provisions for performance studies involving routine sample collections.
- Clear allocation of combined MDR–IVDR products to the IVDR framework where the diagnostic function is primary.
- Strengthened regulatory support mechanisms for small and medium-sized enterprises.
- Enhanced focus on breakthrough technologies, rare disease diagnostics, and high clinical value devices.
MDR: recalibrating the balance between pre-market and post-market evidence
One of the most significant shifts under the MDR reform is the recalibration of evidence generation across the device lifecycle. While clinical investigations remain a cornerstone for high-risk devices, the proposal places greater emphasis on post-market surveillance and PMCF as active tools for confirming safety and clinical performance in real-world use.
This approach reinforces lifecycle evidence generation without lowering regulatory expectations.
IVDR: removing the most problematic procedural barriers
Under IVDR, the reform primarily addresses procedural elements that proved disproportionate in practice. The elimination of the PECP and the simplification of requirements for low-risk performance studies substantially improve regulatory predictability while maintaining robust oversight for higher-risk IVDs.
Direction of travel – a synthetic view
From a system perspective, the reform shifts the EU regulatory framework:
- from uniform scrutiny to a more granular, risk-based approach,
- from pre-market dominance towards a lifecycle evidence model,
- from limited interaction towards structured engagement with notified bodies,
- from procedural rigidity towards improved regulatory predictability.
Practical implications for manufacturers’ regulatory strategies
The proposed reform will directly influence how manufacturers design their clinical and performance evidence strategies. Evidence generation will increasingly need to be planned as a continuous, lifecycle-driven process aligned with risk management and post-market surveillance activities. Clinical Evaluation Reports and Performance Evaluation Reports are likely to evolve into more dynamic documents, reflecting both current evidence and forward-looking data generation plans.
The formalisation of structured dialogue requires manufacturers to engage earlier and more strategically with notified bodies, ensuring that regulatory rationales are coherent, well-documented, and aligned with lifecycle evidence planning. For legacy and well-established devices, the reform creates opportunities to rely more effectively on high-quality post-market data, provided that such data are robust and clinically meaningful.
For IVD manufacturers, simplified performance study pathways improve planning predictability, while simultaneously increasing responsibility for methodological and clinical justification.
Strategic conclusions
The MDR and IVDR reform does not lower regulatory standards. Instead, it redefines how those standards are met by shifting the focus from one-off certification towards continuous lifecycle oversight. Manufacturers that proactively adapt their clinical, performance, and post-market strategies to this model will be best positioned to navigate the next phase of regulatory evolution in the European Union.
More information:
Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices