The Medical Device Coordination Group (MDCG) has published MDCG 2026-4 rev.1, updating its position on the management of the Summary of Safety and Clinical Performance (SSCP) and the Summary of Safety and Performance (SSP) in EUDAMED.
The document, published in October 2026, explains how responsibilities for uploading these documents will evolve following the mandatory use of the first EUDAMED modules.
Current Situation in EUDAMED
Under the current process, the notified body uploads the SSCP or SSP during the registration of certificate information in EUDAMED.
This applies under:
Article 32(1) MDR for SSCPs;
Article 29(1) IVDR for SSPs.
However, MDCG confirms that this approach is changing.
Manufacturers Will Take Over SSCP Uploads
Guidance MDCG 2019-9 rev.1 is being revised so that the manufacturer will become responsible for uploading the SSCP in EUDAMED.
This will include:
the master SSCP;
translations of the SSCP.
The manufacturer must ensure that the version uploaded is the same version that was validated by the notified body during the certification process.
Role of the Notified Body
Although manufacturers will take over the upload task, notified bodies will retain an important verification role.
The notified body will need to indicate which SSCP or part of an SSCP has been validated by selecting the relevant Basic UDI-DI when registering or linking the corresponding certificate.
This creates a clearer division of responsibilities between:
manufacturer upload;
notified body validation;
EUDAMED certificate linkage.
The Same Approach Will Apply to SSPs
MDCG confirms that the same procedure will apply to SSPs for IVDs.
This means IVD manufacturers should also prepare for the transfer of upload responsibilities from notified bodies to manufacturers.
Transitional Period in EUDAMED
The new functionality is being introduced gradually.
MDCG states that EUDAMED changes will be implemented over the coming months and after the date of mandatory use.
A transition period will be provided to move the upload responsibility from the notified body to the manufacturer.
Current Process Since 28 May 2026
From 28 May 2026, when use of the first four EUDAMED modules became mandatory, notified bodies must continue to upload SSCPs and SSPs when registering new certificates or certificate updates.
During this transitional phase, notified bodies upload only the master version of the SSCP or SSP.
Translations are not included in that upload.
Manufacturers Remain Responsible for Translations
Translation management remains the responsibility of manufacturers.
MDCG refers to:
MDCG 2021-1 rev.1;
MDCG 2022-12.
These documents continue to govern translation-related responsibilities during the transition.
New Functionality First Tested in Playground
The new SSCP/SSP functionality is being introduced first in the EUDAMED Playground environment.
It will then be deployed to the Production environment after a transition period intended to allow manufacturers and notified bodies to:
test the functionality;
adapt internal processes;
prepare for compliance.
The document notes that deployment in Playground was planned for July 2026, with Production deployment planned for December 2026.
December 2026 Becomes a Key Milestone
Manufacturers are expected to be able to upload SSCPs and SSPs directly in EUDAMED from December 2026 onwards, once the new functionality becomes available in Production.
This marks an important operational shift for regulatory teams responsible for EUDAMED data management.
Devices Placed on the Market Before Mandatory UDI/Device Module Use
The revised position paper also addresses devices placed on the market before mandatory use of the UDI/Devices module.
Because manufacturers will only be able to upload SSCPs from December 2026, the original six-month transitional period for device registration is effectively shortened for SSCP upload activities.
This creates additional time pressure for manufacturers managing older registrations.
27 March 2027 Deadline
MDCG states that manufacturers should upload the relevant SSCPs and SSPs as soon as possible and no later than 27 March 2027 for devices placed on the market before mandatory use.
Manufacturers and notified bodies are expected to align their timelines to ensure that their respective registration obligations are fulfilled.
This is one of the most important operational deadlines in the revised position paper.
Certificate Transition Runs Until May 2027
The document also notes that notified bodies have a 12-month transition period for uploading corresponding certificates into the Notified Bodies & Certificates module.
That transition period ends on 27 May 2027.
As a result, EUDAMED may temporarily contain devices that have been registered but do not yet have a corresponding certificate or SSCP/SSP linked by the notified body.
Potential Temporary Data Gaps
MDCG recognises that the transition may create periods where:
the device is registered;
the certificate has not yet been uploaded;
the SSCP or SSP has not yet been linked.
This is expected because device registration and certificate registration are operating under different transition timelines.
Manufacturers and notified bodies therefore need to coordinate closely to minimise inconsistencies.
Impact on Manufacturers
For manufacturers of devices requiring an SSCP or SSP, the revised position paper introduces a significant new responsibility.
Manufacturers should prepare to:
upload validated SSCPs and SSPs directly in EUDAMED;
manage translations;
confirm alignment with notified body validated versions;
monitor Basic UDI-DI linkage;
adapt internal EUDAMED procedures;
prepare for Production functionality;
meet the 27 March 2027 deadline where applicable.
Internal SOPs and regulatory responsibilities may need to be updated accordingly.
Impact on Notified Bodies
Notified bodies will move away from being primarily responsible for SSCP/SSP uploads.
Their role will increasingly focus on:
validating the SSCP/SSP;
linking certificate information;
identifying the validated SSCP or relevant sections;
ensuring correct Basic UDI-DI association.
During the transitional period, however, they must continue uploading master SSCPs and SSPs alongside new certificate registrations and updates.
Impact on IVD Manufacturers
The same transition applies to SSPs under the IVDR.
IVD manufacturers should therefore review:
SSP upload responsibilities;
translation processes;
certificate linkage;
Basic UDI-DI mapping;
EUDAMED readiness.
This is particularly relevant for higher-risk IVDs where SSP requirements apply.
What Companies Should Do Now
Manufacturers should consider taking the following steps:
identify all devices requiring an SSCP or SSP;
confirm which documents have already been uploaded by notified bodies;
verify which versions were validated;
prepare translations;
confirm Basic UDI-DI mapping;
test the new functionality in EUDAMED Playground;
update SOPs and responsibilities;
coordinate timelines with notified bodies;
prepare for Production deployment;
prioritise registrations subject to the 27 March 2027 deadline.
Key Dates
The most important dates highlighted by MDCG are:
28 May 2026
Mandatory use of the first four EUDAMED modules began.
July 2026
Deployment of the new functionality in EUDAMED Playground was planned.
December 2026
Deployment in the Production environment is planned, enabling manufacturers to manage SSCPs and SSPs.
27 March 2027
Recommended latest date for manufacturers to upload SSCPs/SSPs for devices placed on the market before mandatory use.
27 May 2027
End of the notified body transition period for certificate uploads.
Impact on EUDAMED Compliance
The revised position paper reflects the gradual transfer of EUDAMED responsibilities from notified bodies toward manufacturers.
For regulatory teams, this means EUDAMED compliance increasingly requires active management of:
device registrations;
SSCPs and SSPs;
translations;
certificate relationships;
Basic UDI-DIs;
timing between manufacturer and notified body actions.
The transition reinforces the need for close coordination across regulatory, quality and notified body interfaces.
