SSCP writing that satisfies notified bodies and stays readable
Summary of Safety and Clinical Performance (SSCP) writing for Class III and implantable devices under EU MDR Article 32, aligned to MDCG 2019-9 guidance. from a clinician led team serving India, MENA, Europe, and global markets.
For implantable and Class III devices, EU MDR Article 32 requires a Summary of Safety and Clinical Performance (SSCP): a public document, validated by the notified body and published in EUDAMED, that summarizes the device's clinical evidence for both healthcare professionals and, where relevant, patients. It is one of the few regulatory documents written for two audiences at once, and MDCG 2019-9 guidance is explicit that the patient facing part must be genuinely understandable to lay readers.
That dual audience is where SSCPs fail review. Copying the clinical evaluation report produces a professional section that is defensible and a patient section that is not; oversimplifying produces the reverse. EvySaif writes SSCPs from the current clinical evaluation report, the risk management file, and the post-market surveillance data, with the clinician led judgment to keep both halves accurate, consistent with the technical documentation, and ready for notified body validation and annual update.
What we deliver
Full SSCP development
Complete SSCPs to MDR Annex XV cross-references and MDCG 2019-9 structure, for initial certification or remediation of rejected drafts.
Patient facing sections
Lay summaries within the SSCP written to health literacy standards and checked for consistency with the professional section and the IFU.
Annual updates
SSCP revisions synchronized with CER, PSUR, and PMCF evaluation report updates so the public document never contradicts the technical file.
Translation source control
Master English SSCPs structured for the multi-language versions EUDAMED publication requires, with terminology control across translations.
Built to the standards that matter
Frequently asked questions
Which devices need an SSCP?
Implantable devices and Class III devices under EU MDR, with limited exemptions such as custom-made devices. The notified body validates the SSCP as part of conformity assessment.
Who is the SSCP written for?
Both healthcare professionals and, for devices intended to be used directly by patients or implanted, the patients themselves, which is why MDCG 2019-9 expects a distinct lay language part.
How often must it be updated?
Whenever the underlying evidence changes materially, and in practice on the same cycle as the CER and post-market surveillance reporting, which is how we schedule updates for clients.