Liaison with Notified Bodies
Strategic management of Notified Body interactions
Engaging with a Notified Body is a key step in the conformity assessment process for medical devices and in vitro diagnostics. QbD Group supports manufacturers throughout Notified Body interactions, helping to ensure structured, clear, and strategy-aligned communication at each stage.
What is liaison with Notified Bodies?
Engaging with a Notified Body is an important step in the conformity assessment process for medical devices and in vitro diagnostics. The quality and timing of interactions with the Notified Body can have a significant impact on the path to CE marking.
Many manufacturers underestimate the complexity of Notified Body interactions. From initial contact and application submission to responding to review questions and managing audit follow-up, each step requires regulatory attention and well-prepared communication.
QbD Group supports manufacturers in their interactions with Notified Bodies, helping to ensure that communications are clear, complete, and aligned with the overall regulatory strategy.
How we support you
Our team brings extensive experience in supporting Notified Body interactions, helping facilitate structured and efficient communication throughout the process.
Strategic NB selection
We guide you in selecting the most suitable Notified Body for your device, aligned with its intended purpose and risk classification.
Application preparation
We support the preparation of your application package, helping ensure it is complete, well-structured, and aligned with Notified Body expectations.
Timeline management
We help plan and monitor key milestones, supporting timely follow-up and helping you stay on track throughout the review process.
Audit readiness
We perform gap assessments and can facilitate mock audits to help you prepare for Notified Body assessments.
Communication coordination
We support the coordination of communications with the Notified Body, helping to ensure clarity, consistency, and timely responses.
Key areas of support
Our Notified Body liaison services cover the full spectrum of interactions:
Initial engagement
We support you in selecting a suitable Notified Body and in preparing your initial application package.
Query management
We coordinate and support the preparation of responses to Notified Body questions, helping ensure timely and well-structured replies.
Audit preparation
We support your team in preparing for Notified Body audits, including the facilitation of mock audits and readiness activities.
Ongoing liaison
We support structured communication with your Notified Body throughout the product lifecycle, helping to ensure continuity and clarity.
Why QbD Group
Your trusted partner
QbD Group has experience supporting manufacturers in their interactions with Notified Bodies for medical devices and in vitro diagnostics.
Experience working with a range of European Notified Bodies.
Strong understanding of MDR and IVDR conformity assessment requirements.
Structured project support to facilitate and coordinate Notified Body interactions.
Flexible engagement models, from targeted ad-hoc support to broader project involvement.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.