IVDR Compliance & CE Certification
Strategic IVDR compliance for secure and sustainable EU market access
The EU In Vitro Diagnostic Regulation (EU) 2017/746 has fundamentally changed how in vitro diagnostics access the European market. QbD Group supports manufacturers with end-to-end IVDR compliance services, from regulatory roadmap to CE certification and long-term post-market compliance.
What does IVDR compliance require?
The EU In Vitro Diagnostic Regulation (EU) 2017/746 has fundamentally changed how in vitro diagnostics access the European market. Compared to IVDD, IVDR introduces stricter performance evaluation requirements, expanded technical documentation, increased Notified Body involvement, and reinforced post-market obligations.
For most IVDs, CE certification under IVDR now requires a structured regulatory strategy, a compliant Quality Management System, robust clinical and analytical evidence, and continuous lifecycle oversight.
QbD Group supports manufacturers with end-to-end IVDR compliance services. From regulatory roadmap to CE certification and long-term post-market compliance.
How we support your IVDR journey
QbD Group guides you through every stage of the IVDR process, ensuring structured preparation, smooth Notified Body interaction, and sustainable compliance.
We build and maintain IVDR-compliant quality management systems that stand up to Notified Body scrutiny.
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Design, implementation, or upgrade of IVDR-compliant QMS (Article 10)
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Translation of IVDR requirements into practical processes, procedures, and templates
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QMS gap assessments with hands-on remediation support
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Development of company-specific quality documentation (not generic templates)
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Execution of internal audits, supplier audits, and mock Notified Body audits
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Ongoing QMS maintenance and inspection readiness support
Key IVDR requirements
IVDR compliance requires manufacturers to demonstrate conformity with Regulation (EU) 2017/746 before placing an IVD on the EU market:
Risk-Based Classification (Class A–D)
Risk class is determined by the intended purpose and defines the applicable conformity assessment route.
Notified Body Certification
Under IVDR, most IVDs require conformity assessment and certification by a designated Notified Body.
IVDR Technical Documentation (Annex II & III)
Your technical documentation must demonstrate that the device meets IVDR safety and performance requirements.
Performance Evaluation & Clinical Evidence
IVDR requires demonstration of scientific validity, analytical performance, and clinical performance.
Post-Market Surveillance (PMS & PMPF)
Continuous monitoring of safety and performance throughout the device lifecycle.
IVDR-Compliant Quality Management System
A structured QMS governing the full device lifecycle in accordance with IVDR.
Person Responsible for Regulatory Compliance (PRRC)
IVDR requires designation of a qualified person responsible for regulatory compliance.
Why QbD Group
Your trusted partner
With proven expertise in IVD and extensive hands-on experience, QbD Group combines flexibility with capacity to support your IVDR journey.
+150 IVDR technical files written
+250 clinical performance studies executed
Experts with years of hands-on IVD industry experience
Proven track record
ISO 13485 and ISO 27001 certified
Recognized by Notified Bodies
Flexible partnerships, from custom support to full outsourcing
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