The Summary of Safety and Clinical Performance
The Summary of Safety and Clinical Performance (SSCP) is a device document written for the public, and it is assembled entirely out of technical documentation that has to be finished before it starts. Preparing one turns on which devices need it and whether they need a section for patients, on what the professional and patient parts carry, and on how the document is tested, reviewed, translated and kept current.
What the SSCP is for and who reads it
The SSCP is an objective summary of the results of the clinical evaluation and can be read as a summary of the clinical evaluation report. It is a balanced one, which means it has to take in all the available clinical data on the device, positive, negative and inconclusive alike. Its purpose is to give the public access to an updated summary of the clinical data and of the device's safety and clinical performance. It was introduced to ensure transparency and accessibility for patients and healthcare professionals, a goal of the regulation that Recital 43 states: transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. It does not give general advice on diagnosing or treating a medical condition, and it replaces neither the instructions for use nor the mandatory information supplied with the patient implant card or any other mandatory document. It supplements the instructions for use, describing the device's end users, whether healthcare professionals or patients, and the essential information related to the device. It is a standalone document. It is probably one of the most important documents under the Medical Device Regulation (MDR), yet the regulation gives only limited information on how to prepare it. In 2019 the Medical Device Coordination Group (MDCG) published guidance on the SSCP covering its content, the minimum content the regulation requires and instructions for preparing it.
Healthcare professionals, who usually use the device, are the usual readers, and the document lets a clinician compare one device against another; patients read the section for patients where one is required. Once it is available everyone can read it, and in 2020 it was expected that physicians might change their treatment strategies and that patients might ask to be treated with a particular device or might even refuse a treatment. Manufacturers read it too, and for them this transparency is a chance to direct attention to their own devices and to gather information on competitors' devices. Given these readers, manufacturers are sometimes tempted to take the document towards marketing. A manufacturer may say that the document seems too technical and ask whether it could move towards marketing, but the SSCP is not a promotional document and is not intended to spread marketing claims. It is available online to the public, every competitor included, and that is better regarded as a chance to improve the device and to learn from one another than as a way to market it. Because the SSCP will be in the public domain and eventually available on Eudamed, the European database on medical devices, it was expected in 2022 to be scrutinised more closely, a new challenge for manufacturers and writers. The writer will need to write it with the intended user in mind and eliminate potentially confusing medical jargon.
Devices that need an SSCP
Article 32 of the MDR requires manufacturers to prepare an SSCP for implantable and class III devices other than custom-made or investigational devices, a requirement new with the regulation. Exempt devices, which the regulation lists, need none either. The requirement is also given as covering all class III and implantable devices, with the summary updated annually.
Devices that need an SSCP include devices used in direct contact with the heart, the central circulatory system or the central nervous system, devices with a biological effect, devices that deliver drugs, active implantable devices, joint replacements, breast implants, surgical meshes, and class IIb devices such as stents for peripheral arteries and veins; exempt devices include sutures, staples, dental fillings, wedges and plates. In one experienced writer's view, a suture used for an aesthetic procedure is still exempt, because the exemption refers to sutures in general, whatever operation they are used in.
Software is not an implantable device and is exempt from the requirement. The SSCP is a requirement of the regulation, so only devices already complying with it need one: a device still certified under the Medical Device Directive needs none until its technical documentation is migrated to the regulation's requirements. A submission under the regulation includes the SSCP with the complete documentation. Neither the postponement of the regulation's application nor the delay to Eudamed lifted that requirement.
One of the first difficulties a writer may meet is agreeing on whether an SSCP is needed at all. A manufacturer may say that the SSCP is not needed for its device but that it would rather prepare one to be on the safe side. The issue comes when teams within the manufacturer disagree: one team prepares the SSCP while the team responsible for the implant card does not prepare the card, an incongruity to be avoided. For every implantable device that is not exempt, the SSCP is prepared together with the implant card, which exists so that a patient can identify the implanted device and reach further information about it. The discussion about whether to prepare the document can be long, and ideally it happens at the beginning of the project.
When a section for patients is required
A section for patients, written in lay language, is required for implantable devices whose patients are given an implant card and for class III devices intended to be used directly by patients. The section for healthcare professionals is always present, a section for patients may be included for any other device where patient information could be relevant, and in general manufacturers are expected to give a rationale when they do not draft one. The manufacturer has the responsibility of deciding whether content for patients is needed. Content for patients may not be needed for exempt devices such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. Another account states outright that these exempt implantable devices need no section for patients.
A device used only by healthcare professionals, such as a non-implantable class III device, needs no section for patients in lay language.
Two audiences do not mean two documents: the section for patients sits in the same SSCP as the section for healthcare professionals, and one document is sufficient. The two sections are separate and clearly distinguishable, so that a patient can tell the lay section from the professional one.
Inputs from the technical documentation
The SSCP should be sourced entirely from the technical documentation. Its main inputs are the clinical evaluation report, the post-market clinical follow-up (PMCF) plans and evaluation reports, and the periodic safety update report (PSUR) with the other post-market surveillance documents, drawing on the design verification and validation reports, the risk management documentation and the instructions for use as the device requires. The clinical evaluation report is the most important input, and the PMCF plan and report may also be inputs, although their content is often also addressed in the clinical evaluation report. At first glance preparing an SSCP looks like more copying and pasting of existing text than real writing, but it has several potential pitfalls. The quality of the SSCP mainly relies on the quality of the technical documentation, so the technical documentation has to be completed before the SSCP can be written. In one experienced writer's view, the SSCP should be the last of these documents, written after them rather than alongside them.
Manufacturers may push the other way, holding that a hard deadline a month away means every document has to be worked in parallel. In the same writer's experience, working in parallel is very difficult and may yield only a draft that has to be reviewed again once everything is settled, so it does not necessarily save time. A manager or a manufacturer can be hard to convince that the SSCP cannot be written before its input documents are ready. If the risk management documentation is not ready, the SSCP cannot proceed. A well-written clinical evaluation report may already contain summarised sections the SSCP can use. Another experienced writer changed the structure of her clinical evaluation reports after writing a first SSCP, because a well-structured report saves a lot of time and can leave preparing the SSCP partly a matter of copying and pasting.
Most manufacturers set up project teams to meet the regulation's requirements, and with the regulation the documentation from the quality, regulatory and clinical sections has become more interdependent, so the SSCP cannot be finalised until the information from other departments is in, just as a clinical evaluation report is compiled from the other sections at the last step. Inconsistency between the SSCP and the technical documentation confuses the notified body, is likely to raise questions and prolongs the review, so timelines need room for review cycles and consistency checks. Three steps help: make clear that the SSCP can only be completed after all relevant input documents are ready and approved, plan sufficient time for review and approval of the document, and think about technical solutions that ensure consistency and streamline review cycles. Microsoft Teams is one tool, among many on the market, for keeping the clinical evaluation plan and report, the PMCF plan and the SSCP consistent.
Contents of the professional and patient parts
Article 32(2) of Regulation 2017/745 sets the minimum content: the summary shall include at least the identification of the device and the manufacturer; the intended purpose of the device with any indications, contraindications and target populations; a comprehensive description of the device; possible diagnostic or therapeutic alternatives; reference to any harmonised standards and common specifications applied; the summary of the clinical evaluation and relevant information on post-market clinical follow-up; the suggested profile and training for users; and information on any residual risks and undesirable effects, warnings and precautions.
The MDCG guidance divides the professional part of the SSCP into nine sections, beginning with basic information about the device and the manufacturer. The professional part covers residual risks and undesirable side effects, diagnostic or therapeutic alternatives, the role of the device with respect to current medical knowledge and the state of the art, training for users, reference to harmonised standards and the revision history, and its key piece is the summary of the clinical evaluation. The patient part follows basically the same structure.
The sections of the two parts correspond: both open with the identification of the device and the manufacturer, the intended use of the device and the device description; the professional part's residual risks, undesirable side effects, warnings and precautions become risks and warnings for patients; both carry the summary of the clinical evaluation, including post-market clinical follow-up; the diagnostic or therapeutic alternatives become a general description of therapeutic alternatives; both carry suggested training for users; and the reference to harmonised standards and the revision history belong to the professional part only.
Some items that look easy in the list of contents may not be that easy to compile. The description of the intended user is one example. Where the intended user is a surgeon, describe extensively what is meant by surgeon, because a surgeon or a medical doctor is not necessarily the same all around the world, and a phrase such as trained to use the device needs its meaning spelled out. One experienced writer reports that a description along the lines of a medical doctor trained to use the device is certainly not well received by notified bodies, which may come back with deficiencies on that description. Whether the intended user is a surgeon or a patient, describe them in detail.
Residual risks and undesirable side effects
A residual risk is what remains after the control measures have been taken, and an undesirable side effect is one related to the device and experienced by the patient or diagnosable or measurable in the patient. The SSCP has to carry at least the information on residual risks and side effects that the instructions for use carry, and then go further: listing them is not enough, and quantitative data has to be included. Source that from the clinical evaluation report, which holds the updated qualitative and quantitative picture. State as well where the data comes from, whether clinical investigations on the subject device, systematic reviews of the literature or incidents such as complaints, and state the relationship to time, for instance the incidence of adverse events across the device's lifetime, which matters particularly for an implantable device.
How finely to quantify each source of risk data depends in part on the device and on the clinical data available. One experienced writer has never gone to that level of detail in an SSCP, presenting risk with a broader view there while keeping the sources separate in the clinical evaluation report, because complaints are usually under-reported and the writer is uneasy presenting them together with complications from studies. Another also presents the data more broadly in the SSCP than in the clinical evaluation report, because the SSCP is already long and has to be translated into many languages, so it should stay simple, but notes where the data derives predominantly from incidents, because incidents are usually under-reported. The risks are quantified in the clinical evaluation report, from which the SSCP takes the appropriate information and presents it in summarised form, and the different sources are ideally quantified separately, since they may not be comparable: complaints are under-reported, while clinical studies usually trace all complications and complaints.
Summary of the clinical evaluation
The summary of the clinical evaluation carries the evaluation results and the data that form the evidence for confirming the general safety and performance requirements, the evaluation of undesirable side effects and risks, and the acceptability of the device's benefit–risk ratio. Following the MDCG guidance, it covers equivalent devices where equivalence is claimed, a detailed summary of the clinical study results, supporting publications or systematic reviews on the subject device, data from post-market clinical follow-up activities and from post-market surveillance, and relevant information from the PSUR, such as an increase in the frequency or likelihood of an event. It also reports the clinical benefits and the success rates in achieving the predefined outcome measures.
Writing for readers with no medical background
The section for patients can be the most enjoyable part of the SSCP and also the most challenging, because a highly technical document has to become understandable to a reader with no medical background, and the manufacturer has to ensure its readability. The MDCG guidance has the writer assume no formal education in a medical discipline and no prior knowledge of medical terminology or clinical research, and the main difficulty is balancing a sufficient level of detail with readability. To call the section "only" a translation of the finished professional section into lay language is misleading: it has to explain the state of the art, alternative treatments, the device, the results of clinical trials, methods of risk mitigation, plans for post-market clinical follow-up and residual risks and side effects to a general audience, which is a real challenge for a writer with a regulatory focus.
The SSCP and a plain language summary share one objective for their language: to make the text comprehensible to someone who is not aware of medical topics, in plain English, with simple words and short sentences.
Avoid abbreviations and acronyms, and where one is unavoidable use it consistently. Explain medical terms in simple language. Rather than writing haemorrhage alone, explain that it means bleeding; a term explained once in lay language can then be used as the medical term through the rest of the text. Consider figures, tables or graphs to visualise data.
Adapting each patient section
Each patient section of the MDCG 2019-9 Rev.1 template poses its own challenges. Device identification can carry the trade name, manufacturer name and address, Basic UDI-DI and first CE-marking year from the professional section. Intended purpose, indications, patient groups and contraindications still need plain-language explanations even when they are taken from the instructions for use, and a glossary may help with complex terminology and abbreviations. Describe the device, the materials touching tissue, any medicinal substances, its mechanism and its accessories according to their relevance to the patient, leaving out technical detail. For a hip implant, a general explanation of the surgery and an image of the mechanism may be more useful than the detail of the accessories the surgeon uses to insert it.
Explain how the manufacturer identifies, controls and manages risks, including its risk management and post-market surveillance, and cover the remaining risks, undesirable effects, warnings, precautions and field safety corrective actions. Render every risk in the instructions for use understandably; a risk may require a sentence or two rather than a single word substitution. The Plain Language Dictionary of the Michigan Library and the CDC's Plain Language Thesaurus for Health Communications help with the wording. Explain and quantify the residual risks and undesirable side effects in a way the patient can follow, and include, as the MDCG guidance recommends, a statement of what to do if the reader believes they are experiencing a side effect related to the device or its use. Limit warnings and precautions to what is relevant to the patient, leaving out details such as the assembly of a hip implant, and explain both the reason for a field action and the response.
Warnings addressed only to surgeons are, in one experienced writer's view, best left out of the section for patients, because carrying them over makes a long document that is harder to read and of no use to the reader they were never written for. One option, among others, is a statement in their place, along the lines that all warnings are addressed to surgeons and applicable healthcare practitioners and that patients should follow their healthcare provider's instructions on warnings and precautions.
For the summary of the clinical evaluation and post-market clinical follow-up, explain the clinical background, the evidence for CE marking and the safety, drawing on investigations, registries, publications and other sources. Tables can compare relevant safety and performance parameters with the state of the art or standard of care. Describe the clinical investigation results so that a patient can understand the data, describe the post-market clinical follow-up activities and what they are for, and present the benefit–risk with the focus on the benefits to the patient.
Briefly describe the most relevant diagnostic or treatment alternatives, including their benefits and disadvantages, tell readers to consult their healthcare professional about them, and make clear that the SSCP is not supposed to provide treatment recommendations. This can also be done in a table. Suggested user training can be carried from the professional section.
Readability testing
Most readers of the SSCP are likely to read below the highest literacy levels, at which long texts can be comprehended and evaluated, and writers used to reading and digesting complex information may be unable to fully grasp the needs of general audiences, which makes testing the readability of the SSCP essential. Under MDCG 2019-9 Rev.1 the readability of the section for patients is assessed, for example, by a test given to laypeople; software can also be used, but given the limitations of its scores a test with laypeople may be the more robust option. Such a test is expected to use a representative group of people, which a manufacturer's employees usually are not, and to follow a predefined plan with an appropriate sample size supported by a statistical rationale; the plan should also describe how updates of the SSCP affect its readability and define criteria for when testing must be repeated.
In one experienced writer's account in 2020, readability studies have to be conducted for an SSCP, as for a pharmaceutical patient leaflet, to ensure that people without a medical background can understand it. The SSCP should pass a readability test with lay audiences, and the test should be traced within the technical documentation. In the same writer's experience at the time, the study need not be repeated for every device: for a range of stents or stent grafts, it can be enough to establish readability once and transfer that study to the other SSCPs.
Lay-writing skills and resources
The SSCP, one of the regulation's new requirements, is a chance for device writers to write for patients , and to test their skills or gain experience in combining regulatory writing with writing for patients. Preparing it takes strong technical writing skills and, in addition, the transfer of a lot of technical content into lay language. A writer who has written the clinical evaluation report may have no experience of writing for a lay audience. Such a writer has two options: to train oneself, or to inform the client or contact person. Resources for training oneself, as of 2020, included the issue of EMWA's journal on writing lay summaries, online readability applications such as readable.com, grammar tools such as Grammarly, books on plain English, the readability metrics built into Microsoft Word, and John Dixon's workshop on readability tools at EMWA conferences. Wider resources for a first SSCP are the MDR itself and the parts of it that bear on the document, the MDCG guidance, EMWA's special interest group for medical devices, a search of Medical Writing online for medical devices, EMWA training on writing skills and on lay summaries, and online material on good lay summary practice, on non-promotional language and on summarising clinical trial results for lay readers.
Some writers have experience of writing plain language summaries for pharmaceuticals, and it can be worth reaching out to them for help with the plain language part.
Review, validation and updates
An SSCP is usually not written alone: the writer needs input from medical advisors and clinical experts, from medical affairs and clinical research, and from quality and regulatory affairs. Because the document will be public, it should be extensively reviewed by several people to make sure its content is correct. The SSCP may need approval from several people with different expectations and backgrounds. Each manufacturer's own procedure says who approves it; approvers include medical affairs, regulatory affairs and quality, with legal, trademark and communications or marketing worth considering, and a data protection specialist where patient privacy and intellectual property are in play. Competitive data are best kept out of the document if at all possible.
The notified body is the final reviewer and validates the SSCP before it is finalised and published on Eudamed, confirming that all the required elements are present and that the content matches the latest version of the technical documentation. Any update beyond a stylistic or genuinely minor change requires re-evaluation by the notified body. A new device needs its SSCP ready for launch, before it is placed on the market, while for a legacy device it goes with the MDR submission. The document is reviewed at least annually thereafter. An update to the PMCF evaluation report, the PSUR or the clinical evaluation report can each trigger an update of the SSCP: a PMCF activity produces a PMCF evaluation report, which feeds the clinical evaluation report, and that is the point at which to ask whether the technical documentation and the SSCP now need revising. A change in any of the technical documents might require an update of the SSCP.
Translation
The SSCP has to be translated into the languages accepted in the member states where the device is sold, under the same requirements that apply to the instructions for use. In 2020 the European Union had 24 official languages. It differs from the instructions for use in two details: one document is prepared per language rather than one multilingual document, and the language requirements can differ between the two audiences, with the section for patients to be provided in all the languages the instructions for use cover. Where there is no English version of the instructions for use, the professional part of the SSCP has to be provided in English for all member states. The condition is also given as a selection of languages for the SSCP that does not include English, in which case an English translation is submitted for healthcare professionals in all member states.
Accounts differ on who validates the translations. By one, the notified body validates only one language version, agreed with the manufacturer and usually the English one, and the manufacturer ensures the accuracy of every other translation. By another, the notified body validates the language translation.
The SSCP is meant to be a comprehensive summary, but a summary, and if it can be kept short it probably should be, since translating a long SSCP can be really cumbersome.
Publication on Eudamed and visibility
In 2020 the SSCP was to be made available on Eudamed, whose launch had been postponed to 2022 and which was then expected to be usable in May 2022. The device's instructions for use had to carry whatever a reader needs to find the SSCP there, namely the link to the public Eudamed website and the Basic UDI-DI. In 2020 it was not known whether documents prepared under the MDR would be published retrospectively once Eudamed was available.
As of 2025, the SSCP faced several limitations in practice: many patients may not know it exists, and it was unclear when Eudamed would be fully operational and whether it would be user friendly; the level of detail varies significantly between manufacturers, limiting the ability to make informed decisions; readability also varies significantly, with no consistent way of evaluating it so far, and patients may find critical safety and performance data hard to understand; and the section for patients is limited to certain device types, although many manufacturers create one even where it is optional. No strategy yet existed to raise awareness of the document, and writers can encourage manufacturers to make their SSCPs more visible, for example on their websites or through links in their social media channels. Its impact on patients was expected to become more apparent with the full implementation of Eudamed.
Length and effort
No ideal length can be given: it depends entirely on the device and the clinical data behind it. One experienced writer's most recent SSCP ran to around 30 pages, a number the writer said means nothing.
The effort, set against that for a protocol or a clinical study report, depends on the quality of the technical documentation and on the complexity of the device. With excellent input documentation from very well-written clinical evaluation reports, one experienced writer needed something like 20 hours, and collaboration with the rest of the team may also move the figure.
A writer working under confidentiality agreements has no finished SSCP to show as an example, but a manufacturer may be able to supply a template, an SOP or an SSCP it has already written. Example SSCPs were expected to become available once Eudamed was online. The MDCG guidance presents a list of contents and a template that can be used.