Where Science Meets Certainty: IVDR Services for Your Market Success
As 80% of IVDs face Notified Body scrutiny for the first time, our specialized guidance transforms overwhelming regulatory requirements into your diagnostic innovation's strongest market differentiator.
The IVDR Consultants Who Decode Europe's Diagnostic Revolution
From laboratory-developed tests (LDTs) to companion diagnostics (CDx), our IVDR specialists skillfully guide products through every classification pathway. As part of our comprehensive IVDR services, they maintain active dialogues with Notified Bodies, contribute to key industry events, and implement strategic evidence generation that meets regulatory demands while optimizing your performance evaluation investments.
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Broad Device Type Expertise
Class B to D In-Vitro Diagnostics, Companion Diagnostics (CDx), In-House Devices (LDTs)

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100+
Combined Years of IVD Consulting and Industry Experience

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95%
Team Members with a PhD (Genetics, Pharmacy, Molecular Biology)

What Clients Say
"Veranex has taken a great deal of the attainment of our IVDR certification success, with documentation and wise advice along the way. We are highly grateful for Veranex’s support in this journey!"
RA/QA Manager, mid-size company, Belgium
What Clients Say
"Our IVDR success couldn't have happened without Veranex’s precious support. We are very thankful and really appreciate our collaboration."
CEO, start-up company, Switzerland
Expert IVDR Services for Diagnostic Pioneers
Veranex’s IVDR services employ a targeted methodology, specifically designed for the unique demands of in vitro diagnostics.
Our expert IVDR consultants excel at transforming your technical data into compelling documentation essential for conformity assessment. We begin by assessing classification and mapping evidence to precisely define your technology's compliance pathway. Then, we guide you in developing intelligent, pragmatic regulatory, quality, and clinical strategies that fully align all requirements with your diagnostic’s intended clinical use and market goals.
Our IVDR Regulatory Expertise

Transitioning Legacy Devices to IVDR
Transitioning Legacy Devices to IVDR
Navigate existing IVD device transitions with comprehensive gap assessments, strategic reclassification analysis, and tailored action plans. We optimize your regulatory pathway while maximizing existing data utility through strategic intended use statement reshuffling.

Launching New Devices under IVDR
Launching New Devices under IVDR
Accelerate new IVD development with integrated market access, regulatory, and clinical strategies. We provide due diligence support, capability building for Technical Documentation and QMS, plus strategic Notified Body interactions from concept to CE marking.

Clinical Assays and CDx
Clinical Assays and CDx
Transform clinical assays into companion diagnostics with specialized CDx expertise. We align device development with medicinal product timelines, determine optimal clinical performance strategies, and navigate submission requirements across key EU markets.

In-House Devices (LDTs)
In-House Devices (LDTs)
Ensure Article 5.5 compliance with practical, risk-based approaches that strengthen existing QMS frameworks. We optimize Technical Documentation based on available lab data while seamlessly integrating IVDR requirements into operational workflows.
Our IVDR Services
We begin with comprehensive evaluation tailored to your device's development stage and regulatory pathway, from transition planning to new launch strategies:
Legacy Devices
- Gap assessment on existing Technical Documentation and QMS against IVDR requirements
- Strategic reclassification analysis to optimize regulatory pathways
- Strategic reshuffling of intended use statements to maximize existing data utility
- Define optimal strategies combining market access, reimbursement, regulatory, and clinical approaches
- Due diligence activities to support investment or partnership decisions
- CDx regulatory milestone identification and medicinal product alignment strategies
- Article 5.5 compliance assessment and tailored QMS strengthening for in-house devices
- Roadmap development with clear timelines and resource allocation
Our IVDR consultants ensure your documentation meets heightened regulatory expectations, whether updating existing systems or building new frameworks from the ground up:
Existing Devices- Complete Technical Documentation updates and mitigation
- QMS updates to integrate IVDR-specific requirements
- Support internal teams in building Technical Documentation
- Support internal teams to build QMS compliant with IVDR and potentially MDSAP/QSR for new products
- Map and secure the regulatory compliance of clinical assays during drug clinical trials (CTR)
- Technical Documentation requirements per Annex II and III of IVDR
- QMS solutions leveraging existing laboratory procedures
- Mitigation support for documentation gaps and deficiencies
- Implementation of IVD-specific risk management procedures
- Creation and optimization of post-market surveillance systems
- Development of Periodic Safety Update Reports (PSURs) and Summary of Safety and Performance (SSP)
See more on our Quality Consulting services:
Learn More
We deliver comprehensive performance evidence strategies tailored to your specific diagnostic technologies and regulatory requirements:
Existing Devices- Comprehensive literature evaluation methodologies
- Performance evaluation strategy development for clinical benefit substantiation
- Risk-benefit ratio parameter identification using State of The Art (SOTA)
- Design and execution of clinical performance studies
- Design of comprehensive analytical performance experiments
- CDx clinical performance data strategy and regulatory prerequisites for pivotal trials
- Justification to demonstrate unmet clinical needs versus available market alternatives
- Post-Market Performance Follow-Up (PMPF) system setup
- IVD-specific benefit-risk determination strategies
- Performance Evaluation Plans and Reports (PEP and PER) creation and expert medical writing
Learn more about our CRO services for IVD manufacturers:
Our IVDR services extend through the entire certification process, providing strategic guidance for first-time submissions or transitioning certifications:
Applicable to Legacy and New Devices, including CDx- Strategic Notified Body selection and engagement through CE marking
- Pre-submission preparation and comprehensive documentation review
- Technical documentation review process management
- Comprehensive support during conformity assessment
- Deficiency mitigation and response preparation during conformity assessment
- EUDAMED registration and implementation support
- Post-certification maintenance planning and execution
- Ensuring the compliance of the assay during drug clinical trials
- Support for the notification of LDTs to competent authorities in accordance with national provisions
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Meet the Team
Meet the Specialists Behind Your Success
Silvia Anghel, Ph.D.
Sr Director, Quality and Regulatory Affairs
Dr. Silvia Anghel has a unique combination of scientific research expertise and extensive industry experience in the field of in vitro diagnostics (IVD). Her distinguished background includes research conducted in prestigious laboratories across Canada and Switzerland, focusing on oncology, metabolism-related, and gastroenterology. Silvia has more than 15 years of industry experience, managing projects related to the development, manufacturing, regulatory compliance, and quality management of IVD devices. At Veranex, Silvia guides manufacturers through regulatory pathways and performance evaluation strategies, leveraging her comprehensive understanding of product lifecycles from development through commercialization. She provides strategic guidance in quality management system implementation, technical documentation development, and critical negotiations with Competent Authorities and Notified Bodies, making her an invaluable resource for companies navigating the complex IVD regulatory landscape.
Julianne Bobela, Ph.D.
Scientific Affairs Director
Dr. Julianne Bobela is a Life Scientist with more than ten years of professional experience in the field of translational research applied to Neuroscience and more than five years of experience in Clinical, Regulatory and Quality Affairs related to Medical Devices and IVDs. Her expertise includes conducting clinical evaluations for medical devices and performance evaluation for IVDs, and preparing technical documentation and strategic planning for regulatory pathways. She is also an active member of the Veranex clinical team, supporting the setup, management and final analysis of clinical studies on medical devices. Julianne is fluent in French, German and English.
Véronique Treil
Director, Quality and Regulatory Affairs
Véronique is a clinical laboratory scientist, with more than 20 years’ experience in medical diagnostics and research laboratory settings. She led several hospital and private laboratories through successful quality accreditations. She held leadership roles in both Quality and Operations in an international Contract Research Organization (CRO), where she developed expertise in drug clinical trials and companion diagnostics (CDx). She led strategic development of molecular diagnostic activities in 5 international sites located in Europe, USA, China and Asia-pacific. She oversaw innovative biomarker assays validation and implementation for diagnostics use in EU and US sites. Véronique focuses on regulatory and quality support for IVDs and clinical studies operations. She brings scientific expertise in Precision Medicine, Molecular Oncology, Pharmacogenomics, Infectious Diseases, Antimicrobial Resistance, and Immunoassays. Véronique speaks French and English.
Case Studies
Success Stories from Our IVDR Consultants’ Support
A Diverse Portfolio of 30 Blood Grouping Devices
Situation
A client faced the complex task of transitioning a diverse portfolio of 30 blood grouping devices from the In Vitro Diagnostic Directive (IVDD) to the stricter In Vitro Diagnostic Regulation (IVDR). The sheer number of devices presented a significant hurdle for achieving timely and efficient CE-marking.
Successes
Through our strategic intervention, the client successfully achieved CE-marking under IVDR for their entire portfolio of blood grouping devices, with a substantial reduction in the number of required conformity assessments (from 30 to 5), saving significant time, resources and accelerating market access.
Services by Veranex
Veranex developed a strategic approach focused on optimizing the conformity assessment process. Our team:
- Devised a sophisticated device grouping strategy: Identified and justified the grouping of the 30 individual devices into just 5 product families, a strategy that was subsequently approved by the Notified Body, significantly reducing the number of required conformity assessments.
- Provided comprehensive Technical Documentation (TD) support: Mitigation of existing technical documentation gaps, ensuring all files met IVDR requirements.
- Led performance evaluation activities: Expert writing of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER).
- Managed analytical performance studies: Oversaw the design and execution of crucial analytical studies to gather necessary data.
- Optimized existing clinical data: Leveraged and optimized all available clinical data, including information from batch-to-batch release, to support the IVDR transition.
A Leading NGS Platform
Situation
A leading provider of a Next-Generation Sequencing (NGS) platform faced the critical need to transition their complex technology from the In Vitro Diagnostic Directive (IVDD) to the stringent requirements of the In Vitro Diagnostic Regulation (IVDR). This involved meticulous attention to detail given the innovative nature of NGS technology.
Successes
Through Veranex's strategic guidance and hands-on support, our client successfully achieved CE-marking for their NGS platform under IVDR. Our collaborative approach ensured that all regulatory hurdles were overcome, enabling the company to maintain market access and continue to provide their cutting-edge diagnostic technology.Services by Veranex
Veranex partnered with the client to strategically address the unique challenges of IVDR compliance for their NGS platform. Our expert team provided comprehensive support, including:
- Strategic Intended Use Optimization: Re-evaluated and restructured the device's intended use, enabling the client to effectively substantiate existing clinical evidence under the new IVDR.
- Meticulous Device Description Redefinition: Ensuring the description was clear, concise, and sufficiently comprehensive for Notified Body reviewers, facilitating a smoother assessment process.
- Expert Performance Evaluation Documentation: Authored the critical Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER), detailing the scientific validity, analytical performance, and clinical performance of the platform.
- Proactive Conformity Assessment Support: Provided continuous support throughout the conformity assessment process, including addressing and preparing responses to all Notified Body deficiencies.
Discover More
Related Services at Veranex
FDA Medical Device Consulting
Maximize global efficiency by pairing your IVDR strategy with streamlined FDA submissions. Our specialized team develops parallel evidence generation plans that satisfy both IVDR and FDA requirements, reducing redundant testing while accelerating simultaneous EU and US market entry for your diagnostics.

Quality Consulting
Build IVDR-ready quality systems that support your entire diagnostic portfolio. Our quality frameworks integrate the specialized batch verification, stability monitoring, and performance evaluation requirements unique to IVDR compliance while creating operational efficiencies across your organization.

EU Authorized Representative
Maintain continuous EU market access with our comprehensive Authorized Representative services. We manage all aspects of regulatory compliance and communication with authorities, providing the local presence manufacturers need under MDR and IVDR requirements.

IVD Clinical Studies
Strengthen your IVDR performance evaluation with our specialized IVD clinical study expertise. We design and manage diagnostic clinical investigations that generate robust evidence for both scientific validity and clinical performance claims, transforming IVDR's stringent clinical evidence requirements into compelling demonstration of your diagnostic's real-world clinical utility.

Partner with Expert IVDR Consultants for Your Regulatory Success
Whether you're transitioning legacy diagnostics or launching innovative tests, our team provides the scientific, technical, and regulatory guidance needed to navigate Europe's new diagnostic landscape with confidence and efficiency.



