Application for certification under Regulation (EU) 2017/745

This guide presents the key stages of the certification process under Regulation (EU) 2017/745 set up by GMED. It guides you through the certification process and explains how to apply to GMED, obtain a quote and submit a formal application for certification of your quality management system and/or devices. This document also describes the different conformity assessment activities, the final review and decision-making stages, and post-certification surveillance and control activities.

The conformity assessment procedures corresponding to your activities, risk class and device type are described. The documents to be submitted as part of the formal certification application for each of these procedures are also detailed.

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