Structured dialogue with SGS Fimko

MDCG 2022-14 and  MDCG 2019-6 rev. 5 encourage Notified Bodies and manufacturers to organize structured dialogues. Structured dialogue is a formalized process of communication between a Notified Body and a manufacturer prior to, during, and after the conformity assessment process.  
Its goal is to clarify expectations, ensure completeness of submissions, and improve efficiency without crossing into consultation. Structured dialogue helps to identify gaps early and fosters mutual understanding, while maintaining the Notified Body’s impartiality.  
The focus of the structured dialogue should be on what needs to be fulfilled, not how to fulfill it. Manufacturer’s questions should respect the Notified Body’s independence,  objectivity and impartiality requirements and should not lead to consultancy.  The responsibility to meet the regulatory requirements remains with the manufacturer. Structured dialogue is not a formal conformity assessment and does not replace any official review nor affect any future certification decisions. 

Structured dialogue with SGS Fimko