CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

General information
Valid from 02.04.2018
Base Documents
CEN/TR 17223:2018
Directives or regulations

Standard history

CEN/TR 17223 provides guidance to manufacturers and conformity assessment bodies on the relationship between EN ISO 13485:2016 and the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices.

EN ISO 13485 describes a quality management system that is applicable to medical devices and is intended for regulatory purposes. The European Regulations for medical devices and EN ISO 13485 present holistic requirements for systematic application of a process approach to quality management into which an organization can incorporate regulatory requirements that are applicable to its activities.

While CEN/TR 17223 describes the interrelationship of individual paragraphs, or parts of a paragraph, of the Regulations with subclauses of EN ISO 13485, this is not intended to imply that these subclauses can be implemented in the absence of the entire quality management system described in the standard.
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