About IVDR.net
Your trusted partner for EU In Vitro Diagnostic Regulation compliance resources.
Our Mission
IVDR.net was founded with a clear purpose: to help IVD manufacturers, regulatory affairs professionals, and quality managers navigate the complexities of the EU In Vitro Diagnostic Regulation (Regulation 2017/746) with confidence and efficiency.
The transition from the In Vitro Diagnostic Directive (98/79/EC) to the IVDR represents one of the most significant regulatory changes in the history of the European IVD industry. New classification rules, enhanced performance evaluation requirements, stricter post-market surveillance obligations, and the introduction of EUDAMED create substantial compliance challenges for organisations of all sizes.
We believe that access to high-quality, professionally crafted compliance resources should not be a barrier to regulatory success. Our templates, checklists, and guidance materials are designed to provide a solid foundation that organisations can customise to their specific needs, saving valuable time and reducing the risk of compliance gaps.
Our Values
The principles that guide everything we create and publish.
Precision
Every template and resource is meticulously crafted to align with the latest IVDR requirements, MDCG guidance, and harmonised standards.
Reliability
Our content is developed and reviewed by experienced regulatory professionals with deep expertise in EU IVD regulation.
Accessibility
We make complex regulatory requirements accessible through clear, practical templates and plain-language guidance.
European Focus
We specialize exclusively in EU IVDR compliance, ensuring depth and accuracy in our area of expertise.
What We Offer
Technical Documentation Templates
Complete template packages for IVDR technical files, including device descriptions, GSPR checklists, and design documentation.
IVDR-Specific Templates
Essential templates for declarations of conformity, labelling, post-market surveillance plans, and regulatory submissions.
Quality Management System Templates
Comprehensive QMS documentation aligned with ISO 13485:2016 and IVDR-specific requirements.
Validation Plans & Reports
Performance evaluation plans, clinical performance study protocols, and validation report templates.
Expert Blog & Resources
Regular articles covering regulatory updates, practical guidance, and implementation insights from experienced professionals.
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