In recent years, there have been major regulatory modifications to the medical device industry. The transition from the In Vitro Diagnostic Directive (IVDD) 98/79/EC to the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has had one of its greatest impacts. The European Union (EU) is spearheading this transition to improve patient safety, ensure traceability, and effectively use diagnostic technology advances. Manufacturers, laboratories, and other stakeholders navigating the regulatory environment need to understand the major developments and the function of IVDR consultants in this evolution.

Stricter Classification System

The most noticeable development is the transition to a risk-based classification system. Approximately 80% of In-vitro diagnostic products were self-certified, according to the IVDD. Manufacturers could self-declare conformity without seeking approval from a NB. The IVDR, in comparison, employs a stricter risk-based classification. It aligns more with international classification standards like the GHTF framework and ISO 13485.

IVD devices are currently divided into four classes: A, B, C, and D. Class D devices are the riskiest, such as those that detect HIV and other life-threatening illnesses. This indicates that under IVDR, around 80% of IVD devices will require Notified Body involvement, compared to only 20% under IVDD.

Wider Scope

Genetic testing, companion diagnostics, and lifestyle or wellness devices that generate health information belong to the new categories that the IVDR adds to the definition of IVD devices. This indicates that a wider range of products comes under the scope of the regulation.

Enhanced Technical Documentation

Manufacturers have to provide more thorough technical documentation. This covers post-market surveillance activities, clinical evidence, and performance assessments. Based on clinical utility and scientific validity, the emphasis on clinical data ensures that devices fulfill strict safety and performance requirements.

Enhanced Post-Market Surveillance (PMS)

The IVDR focuses greater emphasis on ongoing post-market device supervision. Manufacturers must have an effective PMS system in place and submit PSURs regularly based on the device’s risk class. The proactive detection and reduction of risks related to IVD devices is the goal of this strategy.

Unique Device Identification (UDI)

The IVDR mandates that all IVD devices adopt Unique Device Identification (UDI) to enhance transparency and traceability. Better device tracking throughout their lifespan is made possible by this modern technology, which enhances patient safety and makes recalls easier when needed.

Involvement of Notified Bodies

Due to the reclassification of devices and the new, more stringent regulations, notified bodies are even more important under the IVDR in arriving early because the IVDR has limited the number of designated notified bodies for compliance, which causes congestion.

Manufacturers and other stakeholders have experienced several problems migrating from IVDD to IVDR. Significant resources have been required to meet the higher criteria for documentation, clinical performance evidence, and participation with Notified Bodies. Highlighting these issues, only a few Notified Bodies are classified as IVDR, necessitating delays in determining conformity. Although most devices were granted extensions to allow for additional time, implementing modifications within limited time frames has proven to be a particularly difficult period for each person involved.

Consultants have become essential partners for manufacturers and other stakeholders in navigating the complexities of IVDR compliance. They are professionals in all aspects of regulatory compliance and market access in line with the IVDR legacy Roadmap as shown below.

1. Gap Analysis and Strategic Planning:
   Consultants assist manufacturers in conducting detailed gap studies between existing processes and IVDR regulations. They provide practical roadmaps that bridge gaps, assuring resource efficiency and timeliness.
   2. Technical Documentation Support & PMS System Implementation:
   Technical documentation preparation under the IVDR is a difficult task. Consultants help manufacturers acquire, examine, and update documentation to satisfy new standards. This includes ensuring that performance evaluations, clinical evidence, and risk management files are reliable. Also, Consultants assist manufacturers in creating and implementing successful PMS strategies, which include incident reporting, trend analysis, and PSUR preparation.
   3. Navigating the Notified Body:

Navigating the Notified Body Landscape is critical for maintaining IVDR compliance. Consultants assist with the communication process, submission preparation, and response to NB queries, reducing delays and increasing the likelihood of successful compliance evaluations.

4. Training and education:
   The consultants provide internal teams with training on IVDR-specific requirements. This helps manufacturers to establish long-term compliance strategies while being prepared for audits and inspections.
   5. Regulatory Strategy & Risk Mitigation:
   Navigating the IVDR’s intricacies necessitates a clearly defined regulatory strategy. Consultants help identify high-risk areas, reduce potential risks, and ensure smooth transitions in the market.

Conclusion:

The modification in the regulation of in vitro diagnostic devices marks the switch from IVDD to IVDR. To meet the healthcare industry’s ever-changing needs, the IVDR aims to increase patient safety, traceability, and performance criteria. However, establishing compliance is difficult and requires significant resources, experience, and strategic planning.

The IVDR consultant serves a strategic role in the planning stages. Their specialized expertise, practical solutions to the complexities of IVDR compliance, and recommendations ensure that manufacturers maintain adherence to regulations while remaining creative and patient-focused. Manufacturers, consultants, and regulators will shape IVDR’s success as this industry adjusts to this new regulatory reality.

Author: Meena Kumari Malavarapu

EU MDR/IVDR Consultant.