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[Medical devices classification: principles and quality management].

¹Dispositifs Médicaux et autres Produits de Santé, 95, rue de Billancourt, 92100 Boulogne-Billancourt, France. maurice.ventura@cladimed.com

Annales Pharmaceutiques Francaises

|September 20, 2011

Summary

The medical device market lacks standardized naming. CLADIMED, a five-level classification used in France and Belgium, addresses this by providing a structured approach for market analysis and follow-up.

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Area of Science:

Medical device classification
Market analysis standardization
Healthcare product nomenclature

Context:

The medical device market exhibits significant diversity in product references.
A lack of standardized naming conventions hinders effective market analysis and monitoring.
Existing classifications often lack the specificity required for detailed medical device tracking.

Purpose:

To introduce CLADIMED as a standardized classification system for medical devices.
To facilitate accurate analysis and follow-up within the medical device market.
To establish a robust framework for medical device categorization.

Summary:

CLADIMED is a five-level medical device classification system implemented in France and Belgium.
It mirrors the structure of the Anatomical Therapeutic Chemical (ATC) classification for pharmaceuticals.
Managed by the CLADIMED association with a scientific committee ensuring quality and adherence to principles.

Impact:

Enhances the ability to analyze and track the medical device market.
Promotes consistency and comparability in medical device data.
Supports better regulatory oversight and strategic planning in the healthcare sector.