Drugdu.com expert's response:

 

I. Complex Classification Rules

The IVDR expands the risk classification of in vitro diagnostic products from four categories (e.g., List A/B under IVDD) to four classes (A-D), with criteria spanning sample types (e.g., saliva, skin tissue) and disease risks (e.g., infectivity, mortality). For example:

Class D devices (e.g., HIV or COVID-19 test kits) require submission of a Clinical Performance Study Plan (CPSR) and independent testing by EU Reference Laboratories (EURLs).

Class C devices (e.g., tumor biomarker tests) necessitate enhanced performance evaluations and clinical evidence reviews.

Challenge: Insufficient understanding of classification rules may lead to errors in technical documentation or clinical strategies, requiring costly compliance adjustments.

Elevated Clinical Evidence Requirements

The IVDR mandates more comprehensive clinical evidence, including:

Scientific Validity: Verification of the product’s correlation with specific diseases, conditions, or parameters.

Analytical Performance: Demonstration of sensitivity, specificity, and other metrics through laboratory testing.

Clinical Performance: Validation of intended use via real-world data.

Case Example: A company faced a 6-month review delay due to inadequate clinical data, ultimately requiring thousands of additional samples for trials.

Strained Notified Body Resources and Prolonged Review Timelines

Expanded Scope: Approximately 80% of IVD products now require notified body review (vs. ~15% under IVDD), yet notified body capacity remains limited.

Review Duration: Class D devices average 18–24 months for approval, with notified bodies recommending technical documentation preparation 2 years in advance.

Cost Pressures: Certification costs range from thousands to hundreds of thousands of euros, covering clinical testing, documentation, and consulting fees.

Detailed Technical Documentation Requirements

Technical files must include:

Risk Management: Plans and reports adhering to EN ISO 14971 standards.

Performance Evaluation: Biological testing, safety assessments, etc.

Post-Market Surveillance: Regular Periodic Safety Update Reports (PSURs) updated based on risk changes.

Challenge: Notified bodies often reject redundant or poorly structured submissions, forcing repeated revisions.

Unique Device Identification (UDI) and Traceability Mandates

The IVDR introduces a UDI system requiring unique identifiers for all products to enhance traceability and post-market oversight.

Challenge: Manual data alignment across modules and restricted UDI field updates increase operational burdens.

II. Operational Experience and Mitigation Strategies

Proactive Planning and Classification Confirmation

Steps:

Classify products (A-D) based on characteristics, intended use, and risk level.

Consult EU-published classification guidelines to ensure accuracy.

For high-risk products (e.g., Class D), engage notified bodies early to clarify review requirements.

Tool: Use the EU’s NANDO database to identify compliant notified bodies.

Build a Comprehensive Technical Documentation Framework

Key Components:

Product Description: Technical specifications, design, and manufacturing processes.

Performance Evaluation: Scientific and clinical data aligned with IVDR Annex I.

Risk Management: EN ISO 14971-compliant risk plans.

Post-Market Surveillance: PSUR mechanisms updated per risk evolution.

Optimization Tips:

Submit searchable, bookmarked PDFs for efficient reviewer navigation.

Avoid redundant data; focus on critical evidence.

Strengthen Clinical Evaluation and Data Management

Strategies:

Early Planning: Design clinical trial protocols for high-risk products in advance.

Data Integration: Combine existing literature, clinical data, and lab results into a cohesive evidence chain.

Expert Collaboration: Partner with clinical institutions or consultancies to ensure scientific rigor and compliance.

Case Example: A company reduced clinical evaluation time by 30% and costs by collaborating with a European clinical research center.

Select Qualified Notified Bodies and Streamline Review Processes

Selection Criteria:

Full IVDR product scope accreditation (e.g., BSI Netherlands NB 2797).

Proven experience in IVD product reviews and professional assessment capabilities.

Process Optimization:

Coordinate review timelines with notified bodies for quality management system audits.

Promptly address technical feedback to avoid delays.

Establish Cross-Functional Compliance Teams and External Support

Internal Teams:

Appoint a Person Responsible for Regulatory Compliance (PRRC) to oversee regulatory affairs.

Form cross-departmental teams (R&D, Quality, Regulatory) to ensure end-to-end compliance.

External Support:

Engage consultancies for classification, clinical evaluation, and other specialized challenges.

Participate in industry training and seminars to stay updated on regulatory changes.

III. Conclusion and Outlook

The IVDR signifies a comprehensive upgrade to EU IVD market oversight, demanding a systematic approach to address classification, clinical evidence, and notified body constraints. By leveraging proactive planning, data-driven strategies, and expert collaboration, companies can significantly enhance compliance efficiency and success rates. Looking ahead, as EU scrutiny of high-risk products intensifies, organizations must continuously refine quality management systems and adapt to evolving regulations to expedite market entry.

 

By editor