EU IVDR Consulting and Regulatory Writing Services
Expert Strategy and Documentation for In Vitro Diagnostic Devices
At GLOBAL, we provide strategic consulting, regulatory writing, and submission support tailored to the complex requirements of the IVDR. Whether you're transitioning from the IVDD or launching a new IVD product, our team of experts helps you stay compliant and market-ready.
What is IVDR?
The European Union’s In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) significantly increases regulatory requirements for IVD manufacturers. With heightened expectations for clinical evidence, performance evaluation, and notified body oversight, companies must now submit detailed technical documentation to maintain CE marking under the new regulation.
Why Choose GLOBAL for IVDR Services?
- Experience with IVDR Class A through Class D IVDs
- Strong understanding of MDCG guidance and notified body expectations
- Integrated regulatory and scientific expertise
- Flexible support models for startups and global diagnostics firms
- Quality-driven project execution with transparent timelines
Expert Strategy and Documentation for In Vitro Diagnostic Devices
EU IVDR Strategy for Diagnostic Devices
- Gap analysis for IVDR compliance and legacy products
- Classification under Annex VIII
- Performance evaluation strategy and planning
- Roadmaps for Class B, C, and D submissions
- Notified body readiness and response support
Performance Evaluation Report (PER) Writing
- Scientific validity and analytical performance assessment
- Clinical performance studies or justification using state-of-the-art data
- Literature review planning and execution
- PER structure aligned with Annex XIII and MDCG guidance
Performance Evaluation Plan (PEP)
- Defined objectives and data sources
- Criteria for validity, accuracy, and reliability
- Alignment with device intended purpose and classification
Post-Market Performance Follow-up (PMPF) Plan and Report
- PMPF Plan development for Class B, C, and D devices
- Survey and registry planning
- PMPF Reports summarizing real-world evidence
Summary of Safety and Performance (SSP)
- Written for professional and lay audiences
- Consistent with labeling and PER conclusions
- Prepared for EUDAMED registration
Notified Body Submission and Response Support
- Compilation of General Safety and Performance Requirements (GSPR)
- Notified body question response writing
- Alignment of annexes and technical documentation
Frequently Asked Questions
CMC alignment. Incomplete or inconsistent narratives around process validation, stability, and control strategy can delay approval. GLOBAL mitigates these risks early.
NDAs apply to small molecule drugs. BLAs cover biologics, while ANDAs are for generics.
Yes, including literature bridges, integrated summaries, and streamlined development strategies.