Notified Bodies & Certificates In EUDAMED
EU MDR EUDAMED Guide: Certificates & SSCP Compliance
EUDAMED Certificate And SSCP Registration Overview
In EUDAMED, Notified Bodies (NBs) have the possibility to register certificates and Summaries of Safety and Clinical Performance (SSCP) on a voluntary basis. Nevertheless, some specific elements mentioned in the certificate must be registered in EUDAMED before. The elements include the manufacturer, the authorized representative (if any), the system/procedure pack producer and Basic UDI-DI(s).
EUDAMED Guidance For Managing SSCPS And Certificates
The management of certificates and Summaries of Safety and Clinical Performance (SSCPs) is one of the important processes for both manufacturers and Notified Bodies (NBs) in the framework of EUDAMED. Although the task of uploading certificates and SS(C)Ps belongs to NBs, it’s very important for the manufacturer to know the whole procedure of management. The EUDAMED portal provides recommendations on how to manage these documents especially in case of higher risk devices (implantable devices, Class III non IVD medical devices).
Process Of Certification By Notified Bodies In EUDAMED
Notified Bodies issue certificates on the results of conformity assessment procedures that should be passed by manufacturers. The certificates can be divided into several types:
Product Certificates (EU Type Examination Certificate (Annex X): EU Technical Documentation Certificate (Annex IX Chapter II) , EU Product Verification Certificate (Annex XI Part B)).
Quality Certificates (EU Quality Management System Certificate (Annex IX Chapter I): EU Production Quality Assurance Certificate (Annex XI Part A)).
Three identifiers you need to know
NB Number – the Notified Body’s official ID.
Certificate Number – ID of your certificate provided by the Notified Body.
Revision Number (if applies) – increases each time the Notified Body modifies or reissues the certificate while keeping the same certificate number.
Thus, the paper certificate ID consists of: NB number + Certificate number (+Revision number, if applied).
Paper certificate vs EUDAMED version
Paper certificate version – the issued certificate document provided to you by the Notified Body. When there is an amendment in the content of the document, a new version of the paper certificate appears (either revision number or the certificate number increases).
EUDAMED certificate data version – the record in EUDAMED. Each modification and decision creates a new version number (version number 1, version number 2, version number 3…). Even if there is no change in paper, some decisions (Suspended, Re instated) cause the new EUDAMED version to keep history accurate.
In order to register certificates in EUDAMED, a manufacturer should prepare all the required data (for example, UDI-DI of the device) to be entered in the database. In some cases of high risk devices, it might be needed to provide a scientific opinion (for instance, EU Reference Laboratory).
Notified Bodies and Manufacturers Responsibilities in SSCPS In EUDAMED
Validation of SSCPs (summaries of safety and clinical performance) by Notified Bodies according to the Medical device regulations and In Vitro Diagnostic Regulation (IVDR) regulations is one of the main responsibilities of Notified Bodies. The validation will make sure that the SSCPs will contain all elements as required by the regulations and that the information will be aligned with the newest technical documentation.
When several Notified Bodies evaluate various elements of a device's conformity (for instance, EU Type Examination, EU Technical Documentation), the Notified Body that evaluates the Technical Documentation will validate the SSCP.
According to the regulations, SS(C)Ps should be written in such a manner that both the intended user and, where necessary, the patient will understand the document. If SS(C)Ps apply to a device for self testing or for lay use, SS(C)Ps should be provided in languages in accordance with the regulation of each Member State. But only the "master" SS(C)P (which is often an English version) will be validated by the Notified Body. Manufacturers will provide SS(C)Ps in all relevant languages and will indicate the master SS(C)P in the revision history of the document.
Management Of Change For Manufacturers In EUDAMED
The manufacturers must have a reliable change control system in place to handle the updates of their certificates and SS(C)Ps. Notified Bodies may apply restrictions, suspension or withdrawal of the certificate if the manufacturer violates some of the regulations or if there is substantial change to the device or manufacturing process before the approval.
It is crucial to establish a reliable system in manufacturers' QMS for managing changes in the EUDAMED data when needed. The manufacturer will update the system about all changes in post market surveillance, clinical evaluation and risk management of his device.
The EUDAMED guide establishes the timeframes for uploading updated SS(C)Ps by Notified Bodies to guarantee the manufacturers the proper management of their device in EUDAMED.
Conclusion
Overall, EUDAMED is very important to guarantee the transparency and traceability of medical devices in the European Union. Cooperation between manufacturers and Notified Bodies to properly register certificates and SSCPs for high risk devices is necessary. If proper data entry and change control are used, manufacturers will be able to ensure the proper registration and management of the lifecycle of their devices in EUDAMED.
How Morulaa Can Help
Morulaa can help you with the expert consultancy to register your certificates and SSCPs through the EUDAMED process. They will provide accurate data entry and documentation management as well as help you with compliance with MDR/IVDR regulations. Also, they will train you on how to use EUDAMED functionality and monitor your medical device.
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