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IVDR Consulting for IVD CE Marking | Elexes Regulatory Experts
As the EU In Vitro Diagnostic Regulation (IVDR) replaces the IVDD, IVD manufacturers must navigate complex new requirements. Elexes provides tailored IVDR regulatory consulting services to ensure timely CE marking and post-market compliance under EU 2017/746.
From classification to performance evaluation and notified body liaison, our team helps you stay compliant without disrupting innovation. Up to 80% of IVDs now require Notified Body involvement under IVDR, we ensure you’re audit-ready from Day 1.
Our IVDR Consulting Services
The IVDR is more rigorous than ever before, making expert support essential. Our IVDR expert services are designed to guide you from initial planning through certification and beyond.
IVD Classification & GSPR Alignment
We help you determine the correct risk class (Class A-D), ensuring compliance with Annex VIII and alignment with General Safety & Performance Requirements (Annex I).
Performance Evaluation Strategy (PER)
We assist in compiling robust scientific validity, analytical, and clinical performance data in line with Annex XIII. Our support includes setting up performance study protocols and clinical evidence evaluation.
Technical Documentation & Notified Body Submission
Our team prepares your complete Technical File, structured to meet IVDR Annex II/III requirements. We also support notified body submissions and responses to deficiency letters.
Why Choose Elexes as Your IVDR Consulting Partner?
You get more than just documentation, we offer end-to-end strategy, execution, and continuous support.
⦿ Deep understanding of EU IVDR 2017/746
⦿ Experience with EU Notified Bodies for Class B–D IVDs
⦿ Expertise in PMS plans, PSURs, and trend reporting
⦿ Support for legacy products transitioning from IVDD
⦿ Cross-functional team of scientists, QA/RA professionals, and former auditors
Full-Spectrum IVDR Consulting Services
Regulatory Strategy & Planning
⦿ Classification & conformity route selection
⦿ Intended purpose definition & clinical claim alignment
⦿ GSPR checklist completion
Performance & Clinical Evaluation
⦿ Clinical performance study planning
⦿ Evaluation report drafting (PER)
⦿ Literature reviews and post-market clinical follow-up
Technical Documentation & QMS Alignment
⦿ Gap analysis & remediation
⦿ Labeling & IFU review
⦿ IVDR-compliant QMS implementation and updates
Full Lifecycle Support for IVDR Compliance
Elexes goes the extra mile to support your product lifecycle, helping you prepare for audits, post-market activities, and ongoing surveillance under IVDR.
Partner with us for expert support in:
⦿ Periodic Safety Update Reports (PSUR)
⦿ Post-market performance follow-up (PMPF)
⦿ Vigilance reporting & trend analysis
Understand IVDR with Visual Clarity
Your IVDR Success Starts Here
Ready to achieve IVDR compliance without the guesswork? Let Elexes be your partner from strategy to certification!
FAQs
Frequently Asked Questions!
The IVDR (EU 2017/746) is the new regulation for in vitro diagnostic medical devices, replacing IVDD and requiring stricter compliance.
The deadline depends on device classification and certification status. All IVDs must comply by May 2027 or earlier.
Yes, for most Class B–D devices. Class A (non-sterile) may be self-certified.
The Performance Evaluation Report (PER) includes scientific validity, analytical performance, and clinical performance data for the device.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
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