EU IVDR Consulting and Regulatory Writing Services
GLOBAL provides comprehensive EU IVDR regulatory consulting and submission services.
Expert Strategy and Documentation for In Vitro Diagnostic Devices
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.
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.
EU IVDR Strategy for Diagnostic Devices
The IVDR introduces risk-based classification, requiring most IVDs to undergo notified body review. Our team helps you develop a scalable compliance strategy that reflects your device’s classification, intended use, and clinical context.
We support:
- 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
Our EU IVDR Documentation Services Include:
Performance Evaluation Report (PER) Writing
We provide complete authoring and consulting for IVDR-compliant PERs, including:
- 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)
Establish a strong foundation for your performance evaluation:
- 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
Ensure continued performance and safety after CE marking:
- 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)
For Class C and D devices, we author and review the SSP for publication:
- Written for professional and lay audiences
- Consistent with labeling and PER conclusions
- Prepared for EUDAMED registration
Notified Body Submission and Response Support
We help prepare and defend your IVDR submission:
- Compilation of General Safety and Performance Requirements (GSPR)
- Notified body question response writing
- Alignment of annexes and technical documentation
Read more at our blog!
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Expert IVDR Consulting for Medical Devices
We support Class IIa, IIb, and III devices across all therapeutic areas
With a team of experienced regulatory writers and former reviewers, we provide regulatory writing for Class II and Class III devices that meets Notified Body expectations the first time. Whether you need help writing documents under EU IVDR or managing an entire technical documentation package, GLOBAL delivers.
Why Choose GLOBAL for EU IVDR Submission Support?
By partnering with GLOBAL, you can choose how best to utilize our expertise.
- 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
Frequently Asked Questions About EU IVDR
What is the EU IVDR?
The In Vitro Diagnostic Regulation (IVDR 2017/746) is the European regulation that governs the safety and performance of IVDs. It replaces the previous IVD Directive (IVDD) and imposes stricter requirements for clinical evidence, documentation, and post-market oversight.
Who needs to comply with the IVDR?
All manufacturers selling in vitro diagnostic devices in the EU must comply with IVDR. This includes both new products and those already CE marked under the IVDD. Most devices now require notified body review, except for low-risk Class A devices.
What is a Performance Evaluation Report (PER)?
A PER is a required document under IVDR that summarizes clinical, scientific, and analytical data supporting an IVD’s performance and safety. It includes evaluations of scientific validity, analytical performance, and clinical performance.
What is the difference between a PEP and a PER?
The Performance Evaluation Plan (PEP) outlines the approach and methodology for collecting and evaluating performance data. The Performance Evaluation Report (PER) presents the results and conclusions of that evaluation. Both are required under IVDR.
What is a PMPF plan and when is it required?
A Post-Market Performance Follow-up (PMPF) Plan is required for Class B, C, and D devices. It outlines how you will monitor performance after market entry, including studies, surveys, or data reviews. The results are documented in a PMPF Report.
What is the Summary of Safety and Performance (SSP)?
The SSP is a public-facing document required for Class C and D devices. It includes a plain-language summary of the device’s intended purpose, performance, and risks. It must align with the PER and labeling and be uploaded to EUDAMED.
How is IVDR different from IVDD?
We help clients transition from IVDD to IVDR with minimal disruption. IVDR introduces:
- A risk-based classification system
- Expanded scope of regulated products
- Higher clinical evidence requirements
- Mandatory notified body involvement for most devices
- More rigorous post-market surveillance expectations
Can you help with notified body responses?
Yes. We provide notified body response writing, evidence alignment, and remediation planning to address deficiencies or questions raised during the review process.
Ready to start?
Stay ahead of the IVDR transition with GLOBAL’s proven expertise in regulatory strategy and documentation. Whether you need a complete Performance Evaluation Report, PMPF Plan, or notified body response support, we’re here to help.
