Structured Dialogue

Structured Dialogue

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MDCG 2022-14 encourages Notified Bodies to conduct Structured Dialogue with manufacturers

Structured Dialogue offers manufacturers an opportunity to better understand the Notified Body conformity assessment processes for medical devices and IVDs.
 
It may address procedural aspects of pre-application and application processes, Notified Body assessment procedures, high-level aspects of manufacturer’s evidence of conformity or more complex combinations of clinical, technical, and regulatory conformity approaches while maintaining the impartiality of the Notified Body.
MDCG 2022-14

What doesn't fall under Structured Dialogue with BSI

  • Structured Dialogue is different from scientific advice (referred to in MDR and IVDR) which typically falls within the remit of the Expert Panels managed by the European Medical Agency (EMA).
  • Structured Dialogue excludes the Notified Body providing solutions to the manufacturer on how to comply with a specific legislative requirement(s).
  • Structured Dialogue does not have any impact on future certification decisions for the device under application.

A range of comprehensive and proven regulatory services

We provide you with efficient pathways to bring your device to market.

  • People having a discussion
    Doctor consulting
    IVDR >

    The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application.

  • man presenting
    MDR >

    The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD. Entered into force on 25 may 2017 with 26 May 2021 date of application.

  • women presenting
    Lead times >

    Medical Devices & IVDs Capacity and lead times applications and conformity assessments.

  • Doctor performing procedure
    Our excellence pathways >

    Discover our experienced and efficient routes to place compliant and safe devices on global markets.

Key benefits of Structured Dialogue with BSI

  • Available for all phases of your conformity assessment.

  • Engage with the appropriate experts at the Notified Body.

  • Timely discussions to enhance the predictability and efficiency of the certification process.

A leading Notified Body

For over 20 years, BSI has been offering its clients many opportunities for interaction/discussion (Structured Dialogue) with the appropriate NB personnel.
 
Such discussions enhance the efficiency and predictability of the conformity assessment process through all its phases, while respecting the independence and impartiality of the Notified Body.
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Our Structured Dialogue

Discover BSI’s Structured Dialogue offering through each phase of your conformity assessment. To know more, take a look to our dedicated brochure.

Read the brochure