As a leading Notified Body, for over 20 years, BSI has been offering Structured Dialogue.
What is Structured Dialogue
Structured Dialogue offers manufacturers an opportunity to better understand the Notified Body conformity assessment processes for medical devices and IVDs.
For more information see MDCG 2022-14 and MDCG 2019-6.
What does fall under Structured Dialogue
- Outline the key steps before and during the application process.
- Describe Notified Body conformity assessment procedures.
- Highlight essential elements of the manufacturer’s compliance evidence.
- Address more complex scenarios that combine clinical, technical, and regulatory
What doesn't fall under Structured Dialogue
- Differentiates from scientific advice, which typically falls within the remit of the Expert Panels managed by the European Medical Agency (EMA).
- Excludes the Notified Body providing solutions on how to comply with a specific legislative requirement(s).
- Does not have any impact on future certification decisions for the device under application.
Key benefits of BSI Structured Dialogue
- 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.
BSI Structured Dialogue enhances 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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