What can Notified Bodies actually see today?

According to the position paper, current legislation limits Notified Body access to three EUDAMED modules, and even within those, access is restricted to records tied to their own clients:

  • Market Surveillance, released into production in 2026, used by Competent Authorities for non-compliance procedures. Notified Bodies can see records related to the manufacturers they certify.
  • Vigilance, currently available in the playground environment with mandatory use planned for 2027, covering manufacturer reporting such as MIR, FSCA, FSN, PSUR, MTR and PSR. Notified Bodies are meant to see reports their own clients upload.
  • Clinical Investigation / Performance Studies, a module still under development and not yet available even in the playground. Once live, Notified Bodies should be able to see investigations and studies involving CE marked devices from manufacturers they work with.

That third module in particular does not exist yet in any testable form, which means the surveillance role the proposal envisages is, for now, being built around information some Notified Bodies simply cannot reach.

Why does this matter for a manufacturer holding a certificate?

Team-NB frames the issue around what a Notified Body needs to do its post-market job properly: assessing incident characteristics, affected components, root causes, patient outcomes and how often similar events recur, and using all of that to judge whether new information affects the validity of an issued certificate. Without direct, timely access to vigilance and clinical data, the association argues, Notified Bodies end up spending disproportionate resources simply locating and assembling information that should already be centrally available, time that could otherwise go into the actual safety assessment.

For a manufacturer, this has a fairly direct consequence. If a Notified Body’s oversight is more efficient because it has one authoritative source of safety and performance data instead of having to piece it together, that efficiency should translate into steadier, more predictable surveillance planning, rather than an unannounced audit or a technical file review that arrives disconnected from a manufacturer’s actual incident history or PMS record. Team-NB explicitly proposes that audit intensity, frequency and modality be tied to objective, documented criteria: incident history, PMS and vigilance data, QMS maturity and how effectively corrective actions have worked. In other words, a manufacturer with a clean vigilance record and a mature quality system could reasonably expect a different surveillance rhythm than one with recurring issues, but only if the Notified Body has the data to draw that distinction in the first place.

The proposed fix

Team-NB’s suggested amendment to Article 106 is narrow in wording but significant in effect: it would extend the same EUDAMED access currently granted to the European Medicines Agency to Notified Bodies as well, covering both EUDAMED itself and any related electronic system not yet folded into it.

A wider comparison, and what it implies

The position paper also lays out how vigilance and safety information is made available in other jurisdictions, including Australia, Brazil, Canada, Japan, the United States, Singapore and South Korea. In most of these systems, adverse event databases and clinical trial registries are already visible to the public, not just to the regulator. Team-NB uses this comparison to argue that the EU lags behind on integration rather than transparency in principle, and that a single accessible source would bring European oversight closer in line with international practice.

For manufacturers operating across several of these markets, the implication is worth noting even beyond the EU discussion: regulatory information about your devices is often already more visible elsewhere than it currently is within the EU’s own Notified Body ecosystem. Whether or not the Article 106 amendment is adopted, it signals a direction the surveillance system in Europe may be heading, one where the completeness of a manufacturer’s own PMS and vigilance documentation becomes even more central to how its certificate is actually treated.

Link to the document: Team-NB Position Paper – transparency