The In Vitro Diagnostic Regulation (IVDR) represents one of the most significant shifts in European regulatory policy for in vitro diagnostic (IVD) medical devices in decades. Introduced to replace the In Vitro Diagnostic Directive (IVDD), the IVDR establishes a more robust and risk-based regulatory framework aimed at ensuring patient safety and enhancing the transparency of IVD devices on the EU market.
For manufacturers, authorized representatives, notified bodies, and other economic operators, this isn’t a routine update. The IVDR significantly expands requirements for clinical evidence, technical documentation, and post-market surveillance.
It also reshuffles device classification schemes, requiring many previously self-certified devices to undergo notified body involvement for the first time. Therefore, understanding key timelines, challenges, and best practices will be critical for companies seeking uninterrupted EU market access.
Key IVDR Transition Timelines
A Brief History: Why the Rollout Was Extended
Although the IVDR formally came into force on May 26, 2017, the EU granted a five-year transition period, originally ending in May 2022. However, due to limited notified body capacity and the lingering effects of the COVID-19 pandemic, it became clear that many stakeholders weren’t prepared to meet the original deadlines.
In response, Regulation (EU) 2022/112 amended the IVDR to provide a phased transition for “legacy devices”, those that were CE marked under the IVDD prior to May 26, 2022. This extension was critical to prevent market disruption and to give stakeholders more time to comply with the new, more rigorous requirements.
Legacy Device Transition Timeline Breakdown
The new IVDR compliance deadlines for legacy devices vary depending on the device classification:
- Class D devices (highest risk): May 26, 2025
- Class C devices: May 26, 2026
- Class B devices and sterile Class A devices: May 26, 2027
These extensions are not automatic. To qualify, a device must meet specific conditions:
- No significant changes to design or intended purpose after May 26, 2022
- Continued compliance with IVDR requirements for post-market surveillance, vigilance, and registration of economic operators
Important Dates to Track
To avoid non-compliance, manufacturers must monitor the following key milestones:
- May 26, 2022: Final date of application of the IVDD. From this point forward, all new devices must conform to the IVDR.
- Certificate expiration: IVDD certificates may remain valid until their stated expiration date or until the relevant IVDR transition deadline, whichever comes first.
- 2025-2027: Class-specific deadlines for full IVDR compliance, depending on the risk classification.
Failing to align internal timelines with these milestones could result in market withdrawal, even for devices that were previously compliant under IVDD.
Transition Challenges and Pain Points
The IVDR transition has been especially challenging for many manufacturers due to its expanded scope, more demanding requirements, and constrained regulatory infrastructure.
Notified Body Capacity Constraints
As of early 2025, only a limited number of notified bodies are designated under IVDR. This has created bottlenecks for conformity assessments, especially for higher-risk devices that require significant documentation and review.
Delays are common, and many manufacturers are finding it difficult to secure timely access to notified body resources.
Increased Clinical Evidence Requirements
The IVDR raises the bar for performance evaluation and clinical evidence. Under IVDD, many IVD devices were self-certified without formal clinical performance studies.
Now, manufacturers must generate and maintain more robust evidence, including:
- Scientific validity reports
- Analytical and clinical performance data
- Post-Market Performance Follow-up (PMPF) plans
This shift requires both time and resource investment, particularly for legacy products that were never subjected to such scrutiny.
Device Reclassification
The IVDR introduces a new classification system based on risk, as outlined in Annex VIII. As a result, many devices previously classified as low-risk (Class A) under IVDD have moved to Class B, C, or D, requiring notified body involvement for the first time.
This has a significant impact on regulatory strategy, testing requirements, and documentation workload.
Expanded Technical Documentation
The level of detail required for technical documentation has increased significantly.
Manufacturers must now provide a clear, structured file that includes:
- Justifications for clinical evaluation method
- Risk management summaries
- Traceability across the product lifecycle
For many, updating legacy documentation to meet these expectations is a resource-intensive task.
Portfolio and Supply Chain Implications
Some companies are reconsidering the commercial viability of certain legacy products, especially those that are low-volume or resource-intensive to re-certify. This creates additional pressure on supply chains and product lifecycle management strategies.
Tips for a Smooth Transition
Proactive planning is the most effective way to navigate the IVDR landscape. Here are key strategies for manufacturers to reduce compliance risk and position themselves for long-term success.
Start Early with a Portfolio Assessment
Begin by categorizing your product portfolio under the IVDR’s classification system. Identify legacy products, evaluate which ones are eligible for the transitional provisions, and prioritize higher-risk devices that require notified body involvement.
Reclassify Devices and Map Regulatory Strategy: Carefully review Annex VIII classification rules. Misclassification can lead to serious delays or noncompliance. Once classification is confirmed, build a regulatory roadmap that outlines:
- Submission timelines
- Evidence generation activities
- Notified body engagement strategy
Engage with a Notified Body as Soon as Possible
Given the current capacity constraints, early engagement is essential. Communicate with your notified body to understand their availability and requirements.
Establish realistic timelines and build in a buffer for unexpected delays or additional information requests.
Close Gaps in Clinical Evidence
IVDR demands robust performance evaluation. Start PMPF studies if needed, especially for high-risk or legacy devices.
Make sure your clinical evidence supports all indications and aligns with current scientific standards.
Key documents to prepare:
- Performance Evaluation Plan (PEP)
- Scientific Validity Report (SVR)
- Performance Evaluation Report (PER)
Update Your Quality Management System (QMS) and Documentation
Your QMS must be aligned with IVDR principles, including processes for risk management, traceability, and complaint handling. ISO 13485:2016 alignment is essential, and documentation should be audit-ready at all times.
Key focus areas:
- Post-market surveillance plans
- Vigilance reporting protocols
- Up-to-date technical documentation per Annex II and III
Monitor Regulatory Updates
The regulatory landscape is still evolving. The Medical Device Coordination Group (MDCG) regularly releases new guidance documents to clarify IVDR implementation.
Staying informed is critical.
Consider subscribing to:
- MDCG newsletters
- EU Commission updates
- Regulatory intelligence platforms
Use Digital Tools to Streamline the Process
Manual tracking of documents, certificates, and deadlines increases risk. Consider regulatory platforms that centralize these functions and offer audit readiness features.
Tools like RegDesk can help by:
- Mapping compliance milestones
- Managing technical documentation versions
- Tracking notified body communications
- Enabling real-time regulatory intelligence
Common Pitfalls to Avoid
The IVDR transition is complex, but many of the most damaging missteps are preventable.
Here’s what to avoid:
- Waiting too long to initiate submissions: Early action is critical. Notified body queues grow longer by the month.
- Underestimating classification changes: Many devices are now subject to far stricter requirements than under IVDD.
- Assuming IVDD certificates will remain valid without updates: Expiry dates matter, and transitional provisions are conditional.
- Neglecting documentation updates: Outdated or incomplete technical files are a common cause of delays or rejections.
Conclusion
The IVDR marks a new era of regulatory oversight for IVDs in the European Union. While the transition is undeniably challenging, it also presents opportunities to strengthen compliance, improve product quality, and demonstrate a deeper commitment to patient safety.
For manufacturers, the key to success lies in early action, strategic planning, and informed decision-making. By understanding your product portfolio, engaging with the right partners, and investing in documentation and data quality, you can navigate the transition with confidence.
Proactive compliance is more than a legal requirement, it’s a competitive differentiator in an increasingly scrutinized healthcare ecosystem.
