EUDAMED Guide for Notified Bodies & Certificates
EUDAMED CERTIFICATE AND SSCP REGISTRATION OVERVIEW
In EUDAMED, Notified Bodies (NBs) have the option to register certificates and Summaries of Safety and Clinical Performance (SSCP) on a voluntary basis. However, certain elements referenced in the certificate must be registered in EUDAMED beforehand. These elements include the manufacturer, the authorized representative (if applicable), the system/procedure pack producer, and the Basic UDI-DI(s).
EUDAMED GUIDANCE FOR MANAGING SSCPS AND CERTIFICATES
The management of certificates and Summaries of Safety and Clinical Performance (SSCPs) is a critical process for manufacturers and Notified Bodies (NBs) within the EUDAMED system. While Notified Bodies are responsible for uploading the relevant certificates and SS(C)Ps, it’s essential for manufacturers to understand the entire process. The EUDAMED platform outlines procedures for managing these documents, particularly for higher-risk devices such as implantable and Class III non-IVD medical devices.
CERTIFICATION PROCESS BY NOTIFIED BODIES IN EUDAMED
Notified Bodies issue certificates based on conformity assessment procedures that manufacturers must follow. These certificates can be classified into two main categories:
Product Certificates: These include documents like the EU Type Examination Certificate (Annex X), EU Technical Documentation Certificate (Annex IX Chapter II), and the EU Product Verification Certificate (Annex XI Part B).
Quality Certificates: These include documents such as the EU Quality Management System Certificate (Annex IX Chapter I) and EU Production Quality Assurance Certificate (Annex XI Part A).
The three identifiers you must know
NB Number – the Notified Body’s official ID.
Certificate Number – assigned by the Notified Body to your certificate.
Revision Number (if used) – bumps up when the NB updates or re‑issues a certificate but wants to keep the same certificate number.
Together, these make the paper certificate identifier : NB number + Certificate number (+ Revision number, if used).
Paper certificate vs. EUDAMED version
Paper certificate version: the issued certificate document your NB gives you. If the content changes (e.g., an amendment), you get a new paper version (often by increasing the revision number or by issuing a new certificate number).
EUDAMED certificate data version: the record inside EUDAMED. Every update or decision creates a new version number (1, 2, 3, …). Even if the paper doesn’t change, certain decisions (like Suspended or Re‑instated) still create a new EUDAMED version so the public history stays accurate.
For manufacturers to register their certificates in EUDAMED, they must first ensure that all relevant data (such as their device’s UDI-DI) is available in the database. Additionally, for certain high-risk devices, it may be necessary to obtain an official scientific opinion (such as from the EU Reference Laboratory). The guide also explains how these processes improve transparency and traceability, particularly in cases where certificates are refused or modified.
ROLES OF NOTIFIED BODIES AND MANUFACTURERS IN SSCPS WITHIN EUDAMED
A major responsibility for Notified Bodies under the MDR and IVDR is to validate the SSCPs (Summaries of Safety and Clinical Performance). This process ensures that the SSCP contains all required elements as per regulatory standards and that the information aligns with the most up-to-date technical documentation.
When different Notified Bodies are involved in assessing various elements of a device’s conformity (for example, EU Type Examination vs. EU Technical Documentation), the Notified Body responsible for reviewing the Technical Documentation must validate the SSCP.
The regulations require SS(C)Ps to be written in a way that is understandable to both the intended user and, where necessary, the patient. For devices intended for self-testing or lay use, SS(C)Ps must be available in languages specific to individual Member State regulations. However, only the "master" SS(C)P (often the English version) is validated by the Notified Body. Manufacturers are responsible for ensuring that SS(C)Ps are available in all relevant languages and must specify the master version in their document revision history.
CONTROL AND CHANGE MANAGEMENT FOR MANUFACTURERS IN EUDAMED
Manufacturers must have a robust change control process to manage updates to their certificates and SS(C)Ps. Notified Bodies can impose restrictions or suspend/withdraw certificates if manufacturers fail to comply with regulatory requirements, or if substantial changes to the device or its manufacturing process occur before approval is obtained.
It is essential that manufacturers have a well-established system within their Quality Management System (QMS) to track and update EUDAMED data as necessary. This includes keeping the system updated with changes, ensuring all post-market surveillance, clinical evaluations, and risk management measures are documented and aligned with regulatory requirements.
The EUDAMED guide outlines timeframes within which Notified Bodies must upload updated SS(C)Ps, ensuring that manufacturers maintain proper oversight and compliance throughout the life cycle of their devices.
CONCLUSION
In summary, EUDAMED plays a critical role in ensuring the transparency and traceability of medical devices within the European Union. Manufacturers and Notified Bodies must collaborate to properly manage the registration of certificates and SSCPs, particularly for high-risk devices. With proper data entry, change control processes, and compliance with regulatory standards, manufacturers can ensure the successful registration and lifecycle management of their devices in EUDAMED.
HOW MORULAA CAN HELP
In Morulaa expert consultancy to support manufacturers through the complexities of the EUDAMED registration process. They assist with accurate data entry, documentation management, and ensuring compliance with MDR/IVDR regulations. Additionally, Morulaa provides training on EUDAMED's functionality, ongoing monitoring, and guidance on post-market surveillance. Their services streamline the process, reduce regulatory risks, and enhance overall efficiency for manufacturers navigating EU medical device regulations.