EUDAMED User Guide: SSCPs and Certificates

The European Commission published the updated EUDAMED User Guide – Notified Bodies & Certificates (Production v 2.15.1 2025) which provides detailed guidance on the management of certificates as well as the Summaries of Safety and Clinical Performance (SSCPs) for implantable and Class III non-IVD medical devices, and the Summaries of Safety and Performance (SSPs) for Class C & D IVDs. 

Are you a manufacturer trying to register for a EUDAMED certificate? MedEnvoy can assist you. Click here, for more information.

EUDAMED User Guide on SSCPs and Certificates

Although the responsibility for uploading certificates and SS(C)Ps lies with the Notified Body (NB), it is important for manufacturers to understand how these processes are carried out in EUDAMED. In this article, we cover several key areas of consideration for manufacturers for certificate and SS(C)P management in EUDAMED, particularly areas covered by relevant MDCG guidance. 

EUDAMED Certificates Issued by Notified Bodies

Certificates issued by Notified Bodies are dependent upon the conformity assessment procedure applied by the manufacturer and are distinguished into the following two main classes: 

• • 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 Quality Assurance certificate (Annex XI Part A) 
    • EU Production Quality Assurance certificate (Annex XI)

The ability of the NB to register a certificate in EUDAMED is dependent upon other manufacturer (Actor) and device (Device UDI-DI) registration information already being available in the database for selection. It is therefore critical that these activities are completed by manufacturers prior to NB certificate registration. This includes manufacturers having obtained a Basic UDI-DI from their UDI issuing agency and submitting this information in EUDAMED. 

For certain higher-risk devices, the regulations have established “mechanisms for scrutiny” where an official scientific opinion is necessary (e.g., scientific opinion of the EU Reference Laboratory (EURL)). The EUDAMED user guide includes instructions for NBs on how this information may also be attached to Product certificates. 

The user guide also includes several instructions for NBs related to mechanisms in place to improve transparency and traceability where issues have been encountered during the certification process, including registration of refused certificates. For both certificate classes, the reasons for changes that are selectable for NBs include (‘Other’ reason is an option for both classes): 

• Compliance: Failure to close non-conformities 

• Compliance: QMS failure 

• Compliance: Product quality issues 

• Compliance: Requirements of MDR/IVDR regulations not met 

• Client: Manufacturer has gone out of business 

• Client: Fails to meet contractual obligations 

EUDAMED Responsibilities for SSCPs for Both Notified Bodies and Manufacturers

Among NB responsibilities established under the MDR/IVDR is SSCP validation, where the NB assesses that all SSCP elements required under the regulations are included in the manufacturer’s drafted SSCP and that the information presented in the SSCP is accurate and aligned with the most current version of the relevant documents in the Technical Documentation. As indicated in MDCG 2019-9 Rev. 1, where two different NBs have been used for different elements of conformity assessment (e.g. Annexes X and XI), it is the responsibility of the NB that assesses the Technical Documentation (as opposed to the manufacturer’s QMS) to validate the SSCP. 

While it is a requirement under the regulations that the SS(C)P be written in a way that is clear to the intended user and, if relevant, to the patient, and therefore lay use / self-testing devices would require availability in languages according to individual Member State regulatory requirements, only a single “master” SS(C)P is validated by the NB, most commonly the English version (where the version supplied to a NB is not in English, an English version is requested as EUDAMED requires it). Manufacturers will need to ensure the availability of the SS(C)P in all relevant languages and indicate in the revision history in each SS(C)P document the language in the “master” SS(C)P that was validated by the NB. The capability of uploading translations of the SS(C)Ps is also available to NBs. 

By the EUDAMED user guide, the initial SSCP is attached to the certificate(s) uploaded by the NB. 

Control Management for Manufacturers

Information in the user guide also implies the criticality of change control management for manufacturers under the regulations. Among the options available to NBs for issued certificates is the option to place restrictions on certificates or to suspend or withdraw them. In addition to the same reasons stated above that are available to NBs to select in the case of refusing certification, NBs may use the same reasons to place restrictions on or suspend/withdraw, a previously issued certificate as well as where the manufacturer has implemented a substantial change before NB approval. It is critical that manufacturers understand and comply with all requirements related to the management of substantial changes and have a robust change control management process established within their QMS framework, including a robust process to ensure that EUDAMED data is kept up to date. 

Furthermore, the relationship between post-market surveillance (PMS), clinical/performance evaluation, risk management, instructions for use, and SS(C)P should not be under-estimated by manufacturers. The user guide provides an overview of considerations for NBs when managing changes to certificates and SS(C)Ps including clear time limits established within which NBs must upload updated SS(C)Ps in EUDAMED. 

Learn more About EUDAMED Regarding SSCPs and Certificates with MedEnvoy

EUDAMED has been a long time coming. With its gradual rollout nearly complete, many manufacturers still face uncertainty about how to integrate EUDAMED requirements into their existing processes. If you’ve never logged into EUDAMED or are struggling with UDI implementation, MedEnvoy can help.

How MedEnvoy Can Support

MedEnvoy provides end-to-end support to ensure you and your products are fully prepared: 

• Strategic Guidance – Clarifying your specific obligations under MDR/IVDR and how EUDAMED applies to your organization. 
• Actor Registration – Supporting manufacturers with completing the Actor module registration and obtaining their SRN. 
• UDI & Device Registration – Advising on Basic UDI-DI, UDI-DI, and device data submissions, including assisting with bulk uploads. We can also perform bulk uploads on your behalf. 
• Process Design & Integration – Developing workflows and procedures that ensure consistent EUDAMED reporting and timely updates across your product portfolio. 
• Ongoing Compliance Support – Providing continuous monitoring, updates, and hands-on support so you remain compliant as EUDAMED evolves. 

Learn more About EUDAMED Registration

For more information about the EUDAMED registration and how MedEnvoy can help click here.