MDCG publishes Revision 5 of its Guidance on IVDR Classification Rules

The MDCG has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under the IVDR, providing new clarifications and practical examples to support a consistent interpretation of classification rules.

Key takeaways:

• Additional clarifications on several IVDR classification rules;
• Updated examples to support manufacturers in determining the appropriate class of their devices;

This revision further supports stakeholders in ensuring a clear and consistent classification approach with the aim of strengthening the harmonization of the interpretation of the IVDR requirements within the European Union.

DOWNLOAD THE GUIDE MDCG 2020-16 rev.5