Team-NB Calls for Greater Transparency and EUDAMED Access for Notified Bodies
The European Association of Medical Devices Notified Bodies, Team-NB, has published a Position Paper on Transparency, adopted on 6 August 2026.
The paper addresses the role of transparency and access to regulatory information in the context of the MDR and IVDR 2.0 proposal, particularly where notified bodies are expected to plan and conduct more risk-based and proportionate surveillance activities.
Risk-Based Surveillance Requires Better Information Access
Team-NB supports the objective of making surveillance more proportionate and risk-based across the full device lifecycle under both the MDR and IVDR.
The paper states that surveillance intensity, frequency and modality could be adjusted based on objective and documented criteria such as incident history, PMS and vigilance data, QMS maturity and effectiveness of corrective actions.
However, Team-NB emphasizes that risk-based regulatory oversight depends on timely access to comprehensive regulatory information. To exercise greater discretion under the proposal, notified bodies need access to high-quality information on safety, clinical performance and market experience.
Current EUDAMED Access Limitations
The position paper explains that notified bodies currently lack access to crucial information available in EUDAMED.
Under current legislation, notified bodies have access only to certain EUDAMED modules for information related to the manufacturers they work with, including market surveillance records related to their clients, vigilance reports uploaded by their clients and clinical investigation or performance study information where a CE-marked device from their client is used.
Team-NB argues that direct access to these systems would create a single authoritative source of safety, performance and state-of-the-art information, supporting more efficient risk-based oversight and reducing reliance on multiple national and international databases.
Importance of Vigilance and Clinical Evidence
Beyond initial certification, Team-NB highlights that notified bodies play a critical role in post-market surveillance, including determining the scope and timing of surveillance activities and assessing whether new information affects the validity of issued certificates.
To fulfil these responsibilities, notified bodies audit manufacturers, suppliers and subcontractors, review scientific and clinical evidence and monitor vigilance data to remain current with the generally acknowledged state of the art.
The paper also notes that ongoing clinical investigations and performance studies are an indispensable source of evidence, as they may reveal rare adverse events and support understanding of evolving state of the art, benchmark devices, therapeutic alternatives and advances in technology and patient management.
Proposed Amendment
Team-NB proposes an amendment to MDR Article 106 to support both MDR and IVDR notified bodies.
The proposed wording would give the EMA and notified bodies access to EUDAMED and any electronic system referred to in the MDR or IVDR that is not included in EUDAMED.
According to Team-NB, this would help provide direct access to relevant electronic regulatory systems and support enhanced notified body responsibilities more effectively and consistently.
Fragmented International Information Landscape
The position paper includes a table illustrating how vigilance and safety information is currently fragmented across jurisdictions.
The table references public databases and information systems in Australia, Brazil, Canada, Japan, the United States, Singapore and South Korea, including adverse event databases, device registers, clinical trial registers and safety communication systems.
This comparison is used to highlight the need for a single, integrated European source of information accessible to notified bodies.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the Team-NB position paper is relevant because broader information access could affect how notified bodies plan and justify surveillance activities.
Manufacturers should pay particular attention to:
vigilance and incident reporting quality;
PMS and PSUR data;
FSCA and FSN information;
clinical investigation and performance study evidence;
QMS maturity;
corrective action effectiveness;
state-of-the-art monitoring;
readiness for risk-based surveillance;
consistency of regulatory data across systems;
transparency of safety and performance information.
For manufacturers, the key message is that proportionate surveillance depends not only on risk classification, but also on the quality, availability and consistency of post-market, clinical and regulatory data throughout the device lifecycle.
