NEW IMDRF_Publication of the final document IMDRF/IVD WG/N64 FINAL:2021 “Principles of In Vitro Diagnostic (IVD) Medical Devices Classification”.

This guidance document is one of a series that together describe a global regulatory model for medical devices. Its purpose is to assist a manufacturer to allocate its In Vitro Diagnostic (IVD) medical device to an appropriate risk class using a set of harmonized principles. Regulatory Authorities have the responsibility of ruling upon matters of interpretation for a particular medical device.

This document should be read in conjunction with the GHTF document “Principles of Conformity Assessment for IVD medical devices” that recommends conformity assessment requirements appropriate to each of the four (4) risk classes proposed herein. The link between new document on classification and conformity assessment is important to ensure a consistent approach across all countries/regions adopting the global regulatory model recommended by the IMDRF, so that premarket approval for a particular device may become acceptable globally.

Regulatory Authorities who may have different classification procedures are encouraged to adopt this IMDRF guidance as the opportunity permits. This document has been developed to encourage and support global convergence of regulatory
systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health.

Regulatory Authorities that are developing classification schemes or amending existing ones are encouraged to consider the adoption of the system described in this document, as this will help to reduce the diversity of schemes worldwide and facilitate the process of harmonization.