The Medical Device Coordination Group (MDCG) has recently published a position paper addressing the management of Summaries of Safety and Clinical Performance (SSCPs) for medical devices and Summaries of Safety and Performance (SSPs) for in vitro diagnostic medical devices (IVDs) within EUDAMED once the system becomes mandatory.
To better understand the significance of this position paper, it is useful to review the current process and the changes that are being introduced.
Current Situation in EUDAMED
At present, SSCPs under the Medical Device Regulation (MDR) and SSPs under the In Vitro Diagnostic Medical Devices Regulation (IVDR) are uploaded to EUDAMED by the notified body during the certificate registration process. This requirement is established under Article 32(1) of the MDR and Article 29(1) of the IVDR.
However, the management of these documents within EUDAMED is undergoing important changes, as outlined below.
Revision of MDCG 2019-9 Rev. 1
The MDCG is currently revising Guidance MDCG 2019-9 Rev. 1 to transfer responsibility for uploading SSCPs from notified bodies to manufacturers.
Under the revised approach, manufacturers will be responsible for uploading both:
- The validated “master” version of the SSCP; and
- All required translations, in accordance with Article 29(4) MDR.
Manufacturers must ensure that the version uploaded to EUDAMED is identical to the version that was reviewed and validated by the notified body during the conformity assessment and certification process.
To support this change, EUDAMED will introduce new functionality requiring notified bodies to identify the validated SSCP(s), or relevant sections thereof, associated with each Basic UDI-DI. This will be done by selecting the appropriate option(s) when registering or linking the corresponding certificate, in accordance with Article 32(1) MDR.
Further details on the implementation of this process are provided in the revised MDCG guidance.
Impact on IVD Manufacturers
A similar approach will also apply to SSPs for in vitro diagnostic medical devices. Consequently, IVD manufacturers will likewise become responsible for uploading validated SSPs and their translations to EUDAMED, while notified bodies will retain responsibility for confirming which SSPs have been validated during the certification process.
Key Takeaway
The revised framework represents a significant shift in responsibilities within EUDAMED. While notified bodies will continue to validate SSCPs and SSPs as part of the certification process, manufacturers will become responsible for maintaining these documents in EUDAMED, including the upload of the approved master version and all applicable translations. This change is intended to streamline document management and ensure that manufacturers maintain direct control over the information made publicly available through EUDAMED.
The full position paper can be accessed using the following link
