Regulatory Services

Structured Dialogue

Facilitating transparent discussions to help manufacturers navigate conformity assessment.

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 outline the key steps before and during the application process, describe Notified Body conformity assessment procedures, and highlight essential elements of the manufacturer’s compliance evidence. It can also address more complex scenarios that combine clinical, technical, and regulatory requirements, while ensuring the Notified Body’s impartiality throughout.

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.

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Regulatory Services

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.

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Regulatory Services

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.

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Resources

Lead Times

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

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Resources

Our excellence pathways

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

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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.

Why BSI

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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