What is EUMDR CE Marking for In-vitro Diagnostic Device
CE Marking for IVD devices certifies compliance with EU In Vitro Diagnostic Regulation (IVDR 2017/746), covering safety, performance, quality, risk management, clinical evidence, labelling, and postmarket surveillance. It permits legal marketing in the European Economic Area (EEA) while enhancing product credibility, regulatory compliance, market access, and patient safety.
When Do You Need IVDR Support
and What Are the Key Challenges?
From CE Marking to technical documentation, we help you navigate EU IVDR 2017/746 with confidence.
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To place an IVD device on the European market
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To comply with EU IVDR 2017/746 requirements
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To demonstrate device safety and performance
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To obtain CE Marking for IVD products
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To meet importer, distributor, or Notified Body requirements
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To expand business opportunities in Europe
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To improve global regulatory credibility and market acceptance
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Understanding EU IVDR classification and regulatory demand
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Preparing IVDR-compliant technical documentation
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Meeting performance evaluation and clinical evidence needs
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Managing risk management, software validation, usability engineering, and product compliance documentation
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Addressing labelling, UDI, and post-market surveillance
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Coordinating with Notified Bodies and authorities
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Maintaining ongoing compliance and post-market update
Our Approach and Why Choose
Tacit Medtek
A structured, practical approach to IVDR compliance backed by deep regulatory expertise and startup-friendly support.
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Conduct regulatory gap assessment and device classification review
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Determine device classification according to IVDR Annex VIII
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Prepare IVDR-compliant technical documentation and QMS records
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Support performance evaluation and clinical evidence documentation
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Implement risk management and post-market surveillance processes
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Review labelling, IFU, and UDI compliance
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Provide audit preparation and Notified Body support
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Assist with end-to-end CE Marking compliance activities
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Expertise in EU MDR 2017/745 and EU IVDR 2017/746 regulatory requirements
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Support for IVD device classification and conformity assessment
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Assistance with IVDR-compliant documentation and performance evaluation
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Support for labelling, IFU, UDI, and PMS compliance
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Experience in risk management and performance evaluation documentation
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End-to-end regulatory documentation and submission support
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Notified Body communication and audit readiness assistance
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Startup-focused and cost-effective regulatory support
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Global regulatory experience including EU, CDSCO, and international pathways
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Global regulatory experience including EU, CDSCO, and international pathways
What You Will Get Deliverables
Consultancy for documentation — everything you need for a complete, submission-ready IVDR compliance package.
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IVDR regulatory strategy and device classification support
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IVDR-compliant Technical Documentation / Technical File
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Performance Evaluation Report (PER) support
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Labelling, IFU, and UDI compliance review
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Post-Market Surveillance (PMS) documentation
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Internal audit and compliance readiness support
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CE Marking and Notified Body submission assistance
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Performance Evaluation Plan (PEP)
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General Safety and Performance Requirements (GSPR) checklist - IVDR Annex I
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Stability/performance data support
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UDI strategy support
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Declaration of Conformity preparation
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IVDR Annex II & III documentation
IVDR Compliance Case Example
A practical example of how structured IVDR support can improve documentation readiness and help accelerate market entry.
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IVD manufacturer struggled with IVDR classification, technical documentation, and performance evaluation
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Successful IVDR-compliant documentation, improved readiness for notified body review and accelerated market entry.
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Conducted IVDR gap assessment and device classification review
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Prepared IVDR Technical Documentation and Risk Management File
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Supported Performance Evaluation documentation
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Reviewed labelling, IFU, and UDI compliance
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Assisted with QMS alignment and audit readiness
FAQ
Frequently Asked Questions
MDR applies to medical devices, while IVDR applies specifically to In-Vitro Diagnostic (IVD) devices such as diagnostic kits, reagents, and laboratory testing products.
Although not directly mandatory by law, an ISO 13485-compliant QMS is generally expected for IVDR compliance and Notified Body assessment.
Not all IVD devices require Notified Body involvement. Class A non-sterile devices may generally be self-declared, while most Class B, C, and D devices require Notified Body assessment.
Typical documents include Technical Documentation, Performance Evaluation, Risk Management File, labelling, PMS documentation, and QMS records.
The timeline depends on device classification, documentation readiness, testing requirements, and Notified Body review timelines.
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