Euro Convergence: Listen to questions, concerns during structured dialogues with NBs, expert says

BRUSSELS – While structured dialogs with notified bodies don't offer the same opportunities for feedback to medtech companies as presubmission meetings with the US Food and Drug Administration (FDA), they do have their advantages, Ana Matos Machado, a clinical reviewer at TÜV SÜD, said at RAPS Euro Convergence 2025.

The key, she said, is to engage with notified bodies early and pay attention to what they are asking about and any concerns they raise during discussions.

Unlike the conversations manufacturers can have with FDA early in their product development, legally, they cannot get information that may be deemed a consultation during early conversations with notified bodies, said Machado.

When the EU Medical Device Regulation (MDR) was enacted, it included language explicitly stating that notified bodies could not provide consultancy. Since then, the Medical Device Coordination Group (MDCG) has issued guidance encouraging notified bodies and manufacturers to have structured dialogues before and during conformity assessments, where the notified body can provide feedback early in the product development that is not considered consultation.

Machado said that manufacturers can ask notified bodies administrative questions about the onboarding process, fees, and what documents they need to file during the pre-application and post-application phases. They can also ask questions about regulatory guidances that apply to their product, such as leveraging evidence from previous assessments, and asking for technical information, about topics like classification and sampling, for example.

"[A major challenge] is the limitation to discuss new devices in the pre-application stage because, yes, we can discuss previous data, but we can't discuss new data,” said Machado. “I think the impact is probably much bigger on non-class 3 devices because those don't even qualify for the EMA consultation procedure... and not all innovative devices will be class 3.

“You can have innovative devices, breakthrough devices even, that will not be class 3," she added.

While Machado said notified bodies aren't allowed to consult, conduct pre-reviews, or discuss clinical data during the structured dialogues during the pre-application phase, they are able to hold meetings with manufacturers on short notice to review any document or information presented in advance of the filing and discuss previous data relevant to their product. However, she noted that notified bodies have more wiggle room in the post-application phase to discuss clinical investigations, equivalence, open non-conformities, regulatory strategy, and more.

"We can and we do ask questions [in the post-application phase], so always pay attention to the questions we're asking because they do serve a purpose," said Machado. "We can express concerns if we are at the point of the stage where we're discussing, for example, the level of evidence available."

She also noted that at this stage they can also point to relevant guidance documents that manufacturers should consult.

“Please come talk to us, we are not the boogieman,” said Machado “I know notified bodies don’t get the best rap these days, but we definitely try to help, and we definitely try to guide you through the [Medical Device Regulation (MDR)] and all of the requirements.”

Euro Convergence: Listen to questions, concerns during structured dialogues with NBs, expert says

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