Team-NB Calls for Broader EUDAMED Transparency to Support Risk-Adaptive Surveillance
The European Association of Medical Devices Notified Bodies, Team-NB, has presented a briefing note on transparency under the MDR and IVDR.
The note explains why notified bodies need broader access to EUDAMED information to support proportionate, risk-adaptive surveillance, while preserving confidentiality of sensitive information.
The Need for Broader Visibility
According to Team-NB, the Commission proposal gives notified bodies access to EUDAMED information for devices for which they issue certificates.
However, it does not provide broader visibility of vigilance, clinical investigation and performance study data for comparable devices certified by other notified bodies.
Team-NB states that this creates an incomplete EU-market picture, where notified bodies can assess their own certification portfolio but cannot reliably benchmark risks, adverse events, field safety corrective actions or state-of-the-art developments across comparable technologies.
What Broader EUDAMED Transparency Should Provide
Team-NB proposes that broader EUDAMED transparency should support EU-wide visibility of relevant vigilance data, including serious incidents, field safety corrective actions, field safety notices and emerging safety trends for comparable devices.
The briefing note also highlights the importance of access to clinical investigation and performance study information needed to assess state of the art, comparable technologies and relevant adverse events.
This broader access would provide a stronger evidence base for decisions on technical documentation sampling, surveillance intensity and unannounced audits.
Confidentiality Safeguards
Team-NB emphasises that broader access should be accompanied by clear confidentiality rules.
Data accessed through EUDAMED should be used only for regulatory purposes and protected against inappropriate onward disclosure.
The proposal therefore aims to balance better regulatory use of data with protection of confidential information.
Policy Value
Team-NB notes that broader EUDAMED transparency would allow notified bodies to benchmark risks against the wider EU market, not only their own certification portfolio.
It could also reduce duplicate information requests where data are already available in EUDAMED, support consistent escalation where signals justify additional scrutiny and reduce routine burden where compliance is stable.
Overall, the proposal is intended to strengthen patient safety by making surveillance more targeted, evidence-based and proportionate.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, Team-NB’s position highlights the growing importance of consistent, high-quality post-market, vigilance and clinical evidence data.
Manufacturers should pay particular attention to:
vigilance reporting quality;
serious incident and field safety corrective action data;
field safety notices;
clinical investigation information;
performance study information;
state-of-the-art monitoring;
technical documentation sampling readiness;
surveillance escalation triggers;
confidentiality and regulatory data governance.
For manufacturers, broader EUDAMED transparency could mean more evidence-based notified body surveillance, with decisions informed not only by the manufacturer’s own portfolio but also by EU-wide data on comparable devices and technologies.
