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.
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.
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.
Regulatory Services
A range of comprehensive and proven regulatory services
We provide you with efficient pathways to bring your device to market.
Key benefits of Structured Dialogue with BSI
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Available for all phases of your conformity assessment.
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Engage with the appropriate experts at the Notified Body.
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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.
Discover BSI
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.
Contact Us
Get in touch
Enhance the efficiency and predictability of your conformity assessment through BSI Structured Dialogue.
