Free IVDR Resources

Essential free tools, checklists, and official links to support your IVDR compliance journey.

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IVDR Classification Checklist

Navigate the complex IVDR classification rules with our comprehensive checklist covering all Annex VIII requirements and risk classes.

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IVDR Timeline & Key Dates

Essential timeline showing IVDR transitional provisions, key dates for legacy devices, and compliance deadlines through 2028.

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Technical Documentation Outline

High-level outline of the IVDR technical documentation requirements based on Annex II and III.

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IVDR Glossary

GSPR
General Safety and Performance Requirements (Annex I of IVDR)
IVDR
In Vitro Diagnostic Regulation (EU) 2017/746
IVD
In Vitro Diagnostic Medical Device
Notified Body
Organization designated by EU member states to assess conformity of devices
UDI
Unique Device Identification system for traceability
EUDAMED
European Database on Medical Devices
PSUR
Periodic Safety Update Report
PMS
Post-Market Surveillance
Technical Documentation
Complete set of technical files demonstrating conformity with IVDR
Performance Evaluation
Process of assessing and analyzing data demonstrating device performance
Declaration of Conformity
Statement that device meets applicable regulatory requirements
Quality Management System
Formalized system documenting processes and procedures (ISO 13485)

Official EU Resources

IVDR Full Text

Official EU IVDR Regulation text on EUR-Lex

MDCG Guidance Documents

Medical Device Coordination Group guidance

EUDAMED Database

European Database on Medical Devices

Notified Bodies List

NANDO database of designated Notified Bodies

European Commission Health

EC Medical Devices sector information

Note: External links lead to official EU and regulatory body websites. IVDR.net is not affiliated with these organizations.