Summary of Safety and Clinical Performance Writing for Device Manufacturers
Pubrica writes summaries of safety and clinical performance (SSCPs) for manufacturers of implantable and class III medical devices. The SSCP is required under MDR Article 32, validated by your notified body and published on EUDAMED. It contains a section for health professionals and, where the device is intended for lay users, a lay section that presents the same facts in plain language. Our device regulatory writers prepare both sections to MDCG 2019-9 rev 1, cross-read them against your CER, IFU and risk file, and arrange translation into the required market languages.
- Two audiences, one set of facts: the professional and lay sections must be consistent, and the lay section is where most drafts need revision
- Written to MDCG 2019-9 rev 1, the template the notified body validates against
- Consistent with the CER, the IFU and the risk file, because the SSCP is published and anyone can compare the documents
- Residual risks stated clearly, because a notified body returns SSCPs that read as promotional material
- Translated where the device is marketed, into the languages of the Member States where it is placed on the market
Professional section to the templateIncluded
Lay section where requiredIncluded
Consistency with CER, IFU and risk fileIncluded
Translation into market languagesIncluded
Presenting the SSCP as promotional materialNot offered
CER → professional → lay → validated → EUDAMED
- Written to MDCG 2019-9 rev 1
- Two audiences, consistent facts
- Checked against CER, IFU and risk file
- Residual risks stated plainly
- Translated for the markets
Deliverables
Four Core Elements of Every SSCP
The SSCP is a public document, so any inconsistency with your other technical documentation is visible to anyone who reads it.
Example from a lay sectionDevice migration was observed in 1.2% of the study population at 24 months.In the studies, about 1 in 80 people had the device move out of position within two years. If this happens, another operation may be needed to correct it. The number and the fact are unchanged, and the wording is readable by the patient.
Example from a consistency checkA residual risk listed in the risk file but missing from the published summary is an easily found discrepancy that is difficult to explain afterwards.
Example from a reviewNotified bodies validate the SSCP and return versions that read as promotional. A softened SSCP also places the manufacturer in a weaker position if an incident follows.
Example from a translation reviewA lay section that is readable in English but technical in translation meets the wording of the requirement but not its purpose.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Regulatory Guidance and Standards for SSCP Writing
The SSCP is governed by one article and one template, and must be consistent with every other document in the technical file.
SSCP guidance and template (validated structure)
The template the notified body uses to validate the SSCP, including the content of each section and how the lay section differs from the professional section.
Medical Device Regulation (regulation)
Article 32 for the SSCP, Articles 83 to 86 for post-market surveillance, Annex I for the general safety and performance requirements, Annex II for technical documentation and Annex XIV for clinical evaluation and PMCF.
Clinical evaluation guidance (June 2016)
The structure notified bodies still assess against, read alongside MDCG 2020-13, which is the assessment template assessors use.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each project is run, recorded and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our SSCP Writing Process Works
We write the SSCP from the clinical evaluation rather than from marketing material, so that it reads as a regulatory summary.
Source Document Review
We gather the CER, IFU, risk management file and PMS data, since the SSCP summarises these documents and does not add new content.
Professional Section
We write the professional section to MDCG 2019-9 rev 1, covering device identification, intended purpose, the clinical evidence summary, residual risks and the PMCF position.
Lay Section
Where the device is intended for lay users, we present the same facts for patients and test the reading level.
Consistency Check, Translation and Submission
We cross-read the SSCP against the source documents, translate it for the relevant markets and prepare it for notified body validation and EUDAMED publication.
Our Experts
Your SSCP Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
SSCP Writing Service Packages
Pricing depends on device complexity, whether a lay section is required and how many languages are in scope.
SSCP Writing
For implantable and class III devices
Quoted per projectBased on complexity and audience
Delivery By scope
- ✓Professional section to MDCG 2019-9 rev 1
- ✓Lay section where required, readability tested
- ✓Cross-read against CER, IFU and risk file
- ✓Residual risks stated plainly
- ✓Prepared for notified body validation
We write the SSCP from the final CER. Where the CER is still in draft, we recommend waiting, because writing both in parallel leads to inconsistencies.
Deliverables Request a quoteTranslation package
For devices placed on multiple markets
Quoted per projectBased on languages and content length
Delivery By scope
- ✓Translation into market languages
- ✓Independent revision against the source
- ✓Lay section readability checked per language
- ✓Terminology consistent with the IFU
- ✓Version control across languages
Readability review and translation are different checks, so the lay section is reviewed for readability in each language.
Deliverables Request a quoteSSCP Update
For an SSCP that is already published
Quoted per projectBased on what has changed
Delivery By scope
- ✓Changes in CER, PMS and risk file identified
- ✓Both sections updated consistently
- ✓Version and revision history maintained
- ✓Translations updated in step
- ✓Resubmitted for validation
The published SSCP should remain consistent with the current evidence, because the published version is the one patients and professionals read.
Deliverables Request a quoteSend your current SSCP and we will cross-read it against your CER and IFU at no cost. Any inconsistencies between them are public, so it is best to identify them before others do.
Implantable devices and class III devices, under MDR Article 32, other than custom-made and investigational devices.
It is validated by the notified body and published on EUDAMED, unlike the other documents in the technical file.
When the device is intended for use by lay users. The professional section is always required, and the lay section is required in addition when patients are users.
Many implant manufacturers include a lay section regardless, because patients who receive the device read the SSCP whether or not they operate the device.
It must be readable by the patient population the device is intended for. This means testing the reading level rather than assuming it, while keeping every fact from the professional section intact.
A common problem is a professional summary with simplified terminology, which is still difficult to read and no longer precise.
No. It is a regulatory summary validated by a notified body, and using it promotionally creates problems under both the MDR and national advertising rules.
An SSCP that reads as promotional is also routinely returned at validation.
Related Services
Related Regulatory Writing Services
The SSCP summarises four source documents and must be consistent with each of them.
1SOURCE DOCUMENTSsummarised in the SSCP
Clinical evaluation reportThe clinical evidence. Device risk managementThe residual risks.2POST-MARKET DOCUMENTSkeep the SSCP current
PMS and device PSURChanges between SSCP versions. PMCF plan and reportThe PMCF position stated in the SSCP.3PATIENT COMMUNICATIONplain language writing
Plain language summaryThe EU CTR equivalent for clinical trials. Patient education contentContent written for the same readers.Request a Free Consistency Check of Your SSCP and CER
The SSCP is public and the CER is not, so any inconsistency between them can be found by others. We will identify it for you first.