PD CEN/TR 17223:2018

What is this standard about?

It deals with the relationship between the international quality management system standard for medical devices and the requirements of Europe's two main pieces of medical devices legislation.

Who is this standard for?

• All medical devices manufacturers producing devices for the European market
• European medical devices regulatory and conformity assessment bodies

Why should you use this standard?

In the absence of a new European Commission mandate on BS EN ISO 13485, this technical report provides guidance on the relationship between it and the requirements of Europe's two main pieces of medical devices legislation: the European Regulations on Medical Devices (MDR) - Regulation (EU) 2017/745; and In Vitro Diagnostic Medical Devices (IVDR) - Regulation (EU) 2017/746.

Both the standard and the Regulations present holistic requirements for the systematic application of a process approach to quality management into which organizations can add regulatory requirements that apply to their specific activities.

NOTE: While this technical report describes the interrelationship of individual paragraphs or parts of a paragraph of the Regulations with particular subclauses of BS EN ISO 13485, it is not intended to imply that these subclauses can be implemented in the absence of the entire quality management system described in the standard.