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Regulatory Focus™ > News Articles > 2020 > 4 > IMDRF consultations focus on IVD classifications, regulatory assessors

IMDRF consultations focus on IVD classifications, regulatory assessors

Posted 07 April 2020 | By Zachary Brennan 

IMDRF consultations focus on IVD classifications, regulatory assessors

The International Medical Device Regulators Forum (IMDRF) recently released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduc assessments of Conformity Assessment Bodies (CABs).

The 16-page proposed document on IVD classification is meant to help IVD manufacturers select an appropriate risk class using a set of harmonized classification principles and based on the device’s intended use. And when appropriate, the document explains how regulators can rule upon matters of interpretation for a particular IVD.

“The manufacturer should document its justification for placing its product into a particular risk class, including the resolution of any matters of interpretation where it has asked a Conformity Assessment Body and/or Regulatory Authority for a ruling,” the document says.

IMDRF also explains the four-class system to identify IVDs based on their level of risk to individuals and the public. For instance, an IVD with low individual and low public health risk would be Class A, whereas high individual and high public health risk would be Class D.

The document further notes seven classification rules, including what types of IVDs should be classified into the four different classes.

For instance, IMDRF says IVDs intended to be used to detect the presence of, or exposure to, a transmissible agent in blood should be Class D, whereas IVDs intended to detect sexually transmitted agents or being used for blood grouping should be Class C. Pregnancy self-tests and fertility testing would fall into Class B, and Class A IVDs would include reagents or other articles that “possess no critical characteristics intended by the manufacturer to make them suitable for in vitro diagnostic procedures related to a specific examination.”
Comments on the document are due 26 May.


The other proposed document, also open for comments until 26 May, applies to regulatory authorities conducting assessments of CABs. The document is meant to help mitigate the risk of inconsistent or ineffective assessments of CABs by ensuring that regulatory personnel have the necessary competence and training before conducting an assessment or participating in a decision to recognize a CAB.

The 22-page document lays out the responsibilities of a regulator to collect and maintain evidence that demonstrates that personnel involved in assessments and recognition decisions meet the specified competence requirements, which deal with foundational, functional and technical competencies.

By foundational, IMDRF means “generic skills, personal attributes, and behaviors applicable to all personnel and developed through experience,” whereas functional competencies deal more with time management, teamwork and the effective use of information technology. And technical competencies are “unique skills developed through experience and specific knowledge applicable to personnel depending on the scope of activities needed to address subject areas.”

The document further discusses how regulators shall assess and periodically monitor the competence of lead assessors, assessors, recognition managers and technical experts.

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

Tags: IVDs

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