About IVDR.net
Your trusted partner for EU In Vitro Diagnostic Regulation compliance.
Our Mission
IVDR.net was founded with a clear purpose: to demystify EU IVDR compliance and provide practical, expert-crafted resources that help regulatory professionals achieve efficient compliance.
We understand the challenges of transitioning from the IVD Directive to the In Vitro Diagnostic Regulation. Our templates and resources are designed to save time, reduce errors, and give you confidence in your regulatory submissions.
Expert Content
Written by regulatory professionals
IVDR-Aligned
Regularly updated for accuracy
Who We Serve
- Regulatory Affairs professionals in IVD companies
- Quality Managers and Compliance Officers
- Consultants supporting IVDR transitions
- Startups developing IVD devices in the EU
- Notified Body preparation teams
Our Expertise
Regulatory Affairs Team
Content Development
Our team combines expertise in medical device regulations, quality management systems, and practical implementation experience.
Compliance Specialists
Template Creation
Experienced professionals who have supported multiple IVDR certification projects and Notified Body audits.
Industry Advisors
Quality Assurance
Former Notified Body assessors and regulatory authority experts ensuring accuracy and relevance of all resources.
Important Disclaimer
The templates and resources provided on IVDR.net are intended as guidance tools and do not constitute legal or regulatory advice. Each organization's compliance requirements may vary, and we recommend consulting with qualified regulatory professionals and legal counsel for specific situations. Our templates should be adapted to your organization's unique needs and reviewed by appropriate experts.
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