MDR SSCPs and IVDR SSPs Are NOT Labeling: What That Means for Your EUDAMED Upload

By February 27, 2027, medical device manufacturers must upload their validated, translated Summaries of Safety and Clinical Performance (SSCPs) to EUDAMED themselves. IVD manufacturers have the same responsibility for their Summaries of Safety and Performance (SSPs). That’s a lot of documents, in a lot of languages, with a short and rapidly approaching upload window.

This deadline came up repeatedly at the recent RAPS Convergence Conference in Charlotte, NC, mostly in sessions on the status of MDR and IVDR updates (so-called MDR 2.0 and IVDR 2.0). Currently, there are 130 proposed amendments to the MDR—all to be hashed out in a complex "trilogue" between the European Commission, Parliament, and Council. It’s unclear what form the final revised regulations will take. In the meantime, all current obligations remain in force, including requirements for SSCPs and SSPs.

What an EU MDR SSCP Is and Who Needs One

In a previous post, we broke down what an SSCP is, but to give a quick recap: Under Article 32 of the EU Medical Device Regulation (MDR), an SSCP is required for implantable and class III medical devices. It summarizes the clinical evaluation for healthcare professionals and, when patients use the device directly, includes a section written for them. The Summary of Safety and Performance (SSP) is the IVDR equivalent, required under Article 29 for class C and D in vitro diagnostics.

Once the notified body validates an SSCP, it has to be available in the languages of the markets where the device is sold. And it doesn’t end there. For class III and implantable devices, the SSCP is revisited at least once a year as new post-market clinical follow-up (PMCF) data come in, and every update means retranslating and reformatting each language version.

That maintenance is where costs pile up, and most device makers haven't budgeted for it. Writing an SSCP takes long enough. Translating it into 20+ languages, then redoing part of that work every year for every device, adds up to far more.

Where the EUDAMED Timeline Stands

May 28, 2026: The original deadline for uploading SSCPs to EUDAMED was May 28, 2026. This was also when mandatory use of the first four EUDAMED modules began.

June 2026: The Medical Device Coordination Group (MDCG) published MDCG 2026-4. This update clarifies that device manufacturers (not notified bodies) are responsible for uploading validated and translated SSCPs and SSPs to EUDAMED.

July 14, 2026: The upload function went live in the EUDAMED Playground, with plans to make it operational in EUDAMED Production in October 2026.

February 27, 2027: The updated deadline for uploading SSCPs and SSPs for devices already on the market before mandatory EUDAMED use began.

Manufacturers are also responsible for making sure the version they upload matches the one their notified body validated. If you haven’t started, now is the time to take stock of your SSCPs and SSPs. Check which translations exist and which are out of date, and talk to your notified body about how validation will work on their end.

So…Why Aren’t SSCPs Labeling?

It sounds like a technical question, but the answer determines how SSCPs get translated. Many manufacturers send SSCPs through the same process they use for labeling: machine translation followed by a full edit by one linguist, then a second, independent linguist who checks everything again. That level of caution makes sense for an IFU. For an SSCP, it may be more than the risk calls for, and it roughly doubles the human effort on a document you’ll be updating every year.

TransPerfect Medical Device recognized the EU MDR SSCP challenge early and worked with our consulting partner, Qserve Group, to author a memo that characterizes the regulatory function of SSCPs (spoiler alert: they are not labeling). Further analysis suggests that an incorrectly translated SSCP would most likely result in a corrective action, reported in the device’s periodic safety update report (PSUR).

To be clear, translation errors in an SSCP are still serious. A corrective action costs time and money, and nobody wants one in their PSUR. But the risk is different from labeling, and the translation process can reflect that.

You can learn more about the Qserve memo here.

A Smarter Way to Handle MDR SSCPs and IVDR SSPs

With manufacturers now responsible for uploading validated, translated documents, the cost and effort of producing and maintaining them deserve attention sooner rather than later.

That is why TransPerfect Medical Device built a risk-based process for SSCPs and SSPs: AI translation, followed by full post-editing by one qualified medical linguist. The process runs under our ISO 13485 and ISO 9001 quality management systems and follows ISO 14971 risk management principles.

Compared with a standard labeling-style approach, it cuts costs and turnaround times by up to 20%. Major manufacturers have since made it their standard process for SSCPs, saving hundreds of thousands of dollars and weeks of turnaround time. Because SSCPs get updated every year, those savings compound.

If you have SSCPs or SSPs to get ready before February, TransPerfect’s medical device experts can help you work out what needs translating, what needs updating, and how long it will take. Get in touch today.