The summary of safety and clinical performance (SSCP) was introduced to make high-risk medical devices transparent to everyone, including patients and laypersons. Where a patient section is required, it only works if patients can find it, navigate to it and understand it, and each of these steps has its own challenges.
In this blog, I look at three communication challenges that stand between the SSCP patient section and its readers, and at what manufacturers can do about them.
The SSCP in Brief
Under Article 32 of the MDR, manufacturers of implantable and class III devices must draw up an SSCP, have it validated by their notified body and publish it in EUDAMED. Class C and D IVDs have the equivalent summary of safety and performance (SSP) under the IVDR. The MDCG 2019-9 template has a Part 1 for healthcare professionals and a Part 2 for patients. Part 2 is not required for every device. According to MDCG 2019-9, it is needed where the information is relevant to patients, for example for implantable devices that come with an implant card and class III devices that patients use directly. Both parts draw on the technical documentation and must be kept up to date with PSUR and PMCF findings.
The key requirement is in Article 32 itself: the SSCP must be written in a way that is clear to the intended user and, if relevant, to the patient. In practice, three hurdles stand in the patient’s way.
Challenge 1: Finding the SSCP
Finding an SSCP means knowing that EUDAMED exists, navigating to the right module and searching by Basic UDI-DI. That is routine for regulatory professionals, but not for the people the patient section is written for:
- Implant patients: someone who has just had a coronary stent or a pacemaker fitted, or a hip replaced.
- Patients using a device at home: someone dressing a wound with a class III dressing that contains an antimicrobial medicinal substance.
- Aesthetic clients: someone considering a dermal filler treatment at a clinic.
Most of them have never heard of EUDAMED, and few would know what a Basic UDI-DI is without clear instructions.
Even experts struggle. In an informal assessment from April 2025, David Mandley of NAMSA searched public sources and found only 44 SSCPs: 28 in EUDAMED, 14 through Google and 2 elsewhere, as reported by TS Quality & Engineering. This should improve. According to MDCG 2026-4, manufacturers rather than notified bodies will upload SSCPs and their translations to EUDAMED, and SSCPs for devices already on the market should be uploaded by 27 February 2027. EUDAMED will then be the single place to look, but that does not make it easier for patients to find.
MDCG 2019-9 also asks manufacturers to explain in the IFU how to find the SSCP in EUDAMED. But the IFU is most often written for, and handed to, healthcare professionals. It cannot be presumed that patients see it or read it.
Manufacturers see the low uptake too. In its 2025 report on administrative burden under the MDR and IVDR, MedTech Europe notes that translated SSCPs may never be viewed in many languages, and that some manufacturers have had their SSP requested only once, in English. It recommends English by default, with translations only on request. That would save costs. But for a patient, a summary that is not available in their own language is one more hurdle.
WHAT MANUFACTURERS CAN DO
- Link to the SSCP from the device’s web page and from patient information materials.
- Give a short, step-by-step guide to finding the SSCP in EUDAMED, with the exact search details.
- Help healthcare professionals point patients to the SSCP before and after treatment.
Challenge 2: Navigating a Document with Two Audiences
The SSCP template puts two very different audiences in one document. Healthcare professionals expect precise medical terms and detailed clinical data and they are trained in medical and technical language conventions. Patients need everyday language and the big picture first.
Good communication practice keeps such audiences apart. The US Federal Plain Language Guidelines advise addressing separate audiences separately, so that no reader gets confused. Other regulated health information already does this. For medicines, the summary of product characteristics is separate from the package leaflet. For clinical trials, the summary of results for laypersons is separate from the technical summary.
Combining the two audiences in a single SSCP also makes the document hard to navigate. Part 1 comes first and is long: SSCPs range from 5 to 81 pages, with an average of 27.5. A patient who opens an eSSCP must scroll through page after page of technical content before reaching the part written for them. Many will give up and conclude that the SSCP is not meant for them.
Industry recognises the problem. MedTech Europe observes that SSCP content has been driven to be increasingly detailed: “The SSCP is meant to be a SUMMARY, but this is becoming increasingly not the case.” It calls for the SSCP to return to its original purpose: concise and understandable for patients and healthcare professionals.
MDCG 2019-9 recommends a page break between the two parts, so that each can be printed on its own. Print can help some readers, for example people with visual or cognitive impairments. But the SSCP is a living document, updated with PSUR and PMCF findings and translated into local languages. In line with the move to electronic labelling such as eIFUs, the EUDAMED version should be the reference version, and printed copies should be clearly marked as snapshots.
WHAT MANUFACTURERS CAN DO
- Put a signpost on the first page: “Are you a patient? Your summary starts on page X.”
- Start the patient section on a new page with a clear, friendly heading, so it can be read and printed on its own, as recommended by the MDCG.
- Make the PDF accessible: searchable, readable by screen readers, and with large, high-contrast text, as the Good Lay Summary Practice recommends for lay summaries.
- Date any printed copies and say where the latest version can be found online.
Challenge 3: Writing in Plain Language Understandable to Laypersons
Even when patients get to the patient section, many cannot understand it. As a 20-year review of patient education materials points out, the American Medical Association recommends a sixth-grade reading level for patient materials (a reading age of around 11–12), and the US National Institutes of Health recommends eighth grade. Yet only 2.1% of the 2,585 materials in the review met the sixth-grade standard and 8.2% met the eighth grade level. To my knowledge, the readability of SSCP patient sections has not yet been studied, but I would expect the same pattern.
In my experience, the main cause is the writing process and the communication skills of the writer. The SSCP patient section is often adapted from Part 1 by the same technical writers, using the same template and style. Without a writer with plain language skills, long sentences, passive constructions, zombie nouns and unexplained medical terms slip through. MDCG 2019-9 sets the bar: assume no medical education or knowledge of clinical research, and check readability with laypersons. But it gives little practical advice on how to get there.
MedTech Europe makes a similar point about the SSP for IVDs: the content has become so focused on regulatory terminology and detail that it is hard for the target audience to understand.
Lessons from Lay Summaries of Clinical Trials
Clinical trials guidelines offer more mature guidance. The EU Clinical Trial Regulation (EU CTR) requires a lay summary of clinical trial results, and two EU guidance documents explain how to write these summaries: Summaries of Clinical Trial Results for Laypersons, from the Commission’s expert group on clinical trials, and the Good Lay Summary Practice (GLSP) guidance, adopted by the Clinical Trials Expert Group in 2021. I was a contributor to and editor of the GLSP guidance. Neither was written for SSCPs, but their writing principles transfer directly to the SSCP patient section which some medical device manufacturers miss.
ISO 24495-1, the international plain language standard, brings these principles together for any type of document. It is a useful benchmark for the SSCP patient section although it is not sufficient for all specific use cases. For more information on plain language visit Sealion's blog on Zombie nouns and plain language.
Conclusion
The SSCP was created to make device information transparent to everyone, including the people who use these devices. That only works if patients can find it, navigate to the part written for them and understand it.
Each part of the SSCP needs its own expertise. Part 1 calls for regulatory and clinical expertise; the patient section calls for plain language expertise as well. Planning for both from the start is far easier than fixing the patient section late in the process.