The Medical Device Regulation (MDR) has significantly reshaped the regulatory landscape in the European Union. With multiple deadlines, ongoing challenges, and growing concerns among industry experts, the transition remains a complex process for manufacturers. Here’s a comprehensive look at the current state of the MDR, major hurdles, and the path forward.
A Brief History of the MDR Transition
- May 26, 2021: The MDR officially came into effect. From this date, all new devices placed on the market had to comply with the MDR.
- May 26, 2024: The initial end of the transition period for MDD-certified devices. After this date, devices must meet MDR requirements to stay on the market.
- March 15, 2023: Regulation (EU) 2023/607 introduced extensions for certain devices.
- May 27, 2027: Extended transition deadline for Class III and Class IIb implantable devices.
- May 27, 2028: Extended transition deadline for Class IIb (non-implantable) and Class IIa devices.
- Post-May 26, 2024: Devices already placed on the market can remain available indefinitely without restriction, provided they comply with MDR.
Regulatory Challenges: A Look at the Data
A Notified Body survey (June 2024) published by the European Commission revealed the primary reasons for application refusals:
- 55%: Outside the scope of the Notified Body’s designation (trend rising)
- 16%: Application incomplete (trend stable or rising)
- 14%: Incorrect product classification (trend rising)
These findings highlight persistent submission challenges, with manufacturers struggling to align with MDR requirements.
Notified Bodies: Shortage Still an Issue?
The availability of Notified Bodies remains a critical bottleneck. Many manufacturers experience extended review times, leading to certification delays. While regulatory agencies attempt to expand capacity, the shortage of qualified experts remains a concern, particularly for small and medium-sized enterprises (SMEs).
Major Changes Introduced by the MDR
- Regulatory Framework Shift: From a directive to a regulation, ensuring consistent application across EU states.
- Expanded Scope: New product categories, such as certain aesthetic devices and medical software, now fall under MDR.
- Stricter Requirements: Greater safety, performance, and clinical data emphasis.
- Increased Documentation: More comprehensive technical files and post-market surveillance obligations.
- Enhanced Oversight: Stricter scrutiny by Notified Bodies and competent authorities.
Efforts Required for Compliance
To successfully transition to MDR, manufacturers must:
- Develop a compliance strategy
- Conduct gap assessments to identify necessary adjustments
- Rationalize product portfolios to meet MDR standards
- Update technical documentation and SOPs
- Train employees on new regulatory requirements
Key Challenges for Manufacturers
- Resource Allocation: High costs and extensive manpower required for compliance
- Notified Body Delays: Long certification timelines and backlog issues
- Tight Deadlines: Pressure to meet extended transition period deadlines
- Regulatory Complexity: More stringent and detailed requirements
- Market Impact: Potential loss of products due to non-compliance
Market Impact: Innovation and Supply Chain Disruptions
Many companies, particularly SMEs, struggle with the financial and regulatory burden of MDR. This has led to a decline in product availability, patient access to treatment delays, and slowed innovation due to increased compliance costs.
- Develop a compliance strategy
- Conduct gap assessments to identify necessary adjustments
- Rationalize product portfolios to meet MDR standards
- Update technical documentation and SOPs
- Train employees on new regulatory requirements
MDR/IVDR Debate: What Experts Are Saying
Structural Reform Advocates:
- Petra Zoellner (MedTech Europe) and Christina Ziegenberg (BVMed) argue for major legislative changes.
- Concerns include product withdrawals, disproportionate effects on SMEs, and delayed patient access.
Implementation Critics:
- Graeme Tunbridge (BSI) and Michel Marboeuf (Stryker) see implementation as the primary issue.
- Propose reducing MDCG guidance complexity and streamlining processes.
- Highlight the need for better communication between stakeholders and Notified Bodies.
Both sides agree on the need for action, but the approach remains contested. Meanwhile, ongoing EU regulatory discussions (such as the AI Act and IEC 60601-1 harmonization) suggest future shifts in compliance strategies.
Conclusion
Manufacturers have more time with the extended transition deadlines, but the fundamental challenges remain. Companies must:
✅ Act now to finalize MDR compliance
✅ Work closely with Notified Bodies to avoid certification delays
✅ Invest in regulatory expertise to navigate evolving requirements
The MDR journey is far from over. Staying proactive, informed, and engaged in industry discussions will ensure continued market access and patient safety.
Are you struggling with MDR compliance?
Antonios is a Senior Quality & Regulatory Affairs Manager, an accomplished expert in quality management and regulatory compliance regarding development and production of medical devices with over 20 years of experience supporting startups, SMEs and multinational manufacturers.
Antonios specializes in ISO 13485, MDR, and FDA regulations, guiding organizations in the development and implementation of robust quality management systems. Acknowledging Regulatory requirements in a fast paced global environment. His hands-on approach and in-depth knowledge of technical documentation, risk management, software lifecycle management, usability engineering and clinical evaluation ensure that innovations are brought to market efficiently and in full compliance with global standards.
Dedicated to delivering sustainable outcomes, he works closely with partners to enable secure international market access with confidence.