MDCG 2019-9: Summary of safety and clinical performance (SSCP), explained

Who this applies to

Under MDR Article 32, manufacturers of implantable devices and class III devices must prepare a summary of safety and clinical performance. Custom-made and investigational devices are excluded. The notified body validates the SSCP and makes it publicly available through EUDAMED.

The audience determines the structure. Devices used only by healthcare professionals need a professional section. Devices intended to be used directly by patients need both a professional section and a patient section, with the patient information written and tested for the expected reader. The SSCP is not merely the CER's executive summary pasted into a public form.

What the SSCP is — and is not

The SSCP presents the important safety, performance, and clinical evidence behind the device in a public and understandable form. Its claims must trace back to controlled technical documentation, particularly the clinical evaluation, risk management, post-market surveillance, and PMCF records.

It must be objective and should include both favourable and unfavourable information. Promotional comparisons, unsupported superlatives, and selective reporting do not belong in it. The document does not replace the label, instructions for use, implant card, or advice from a healthcare professional.

Use a unique manufacturer reference for each SSCP and identify the manufacturer, including its single registration number where available. Link the document to the device's Basic UDI-DI. The document should be a searchable, non-editable PDF rather than a scan, and the version and issue date should be obvious.

What belongs in the professional section

MDCG 2019-9 provides a structured template. In practical terms, the professional section should cover:

The summary should let a professional see what evidence supports the intended purpose and benefit-risk conclusion without reproducing every study table from the CER. Explain the important limitations and uncertainties rather than hiding them in a reference.

Writing for patients

Where a patient section is required, change the language, not the evidence. Explain what the device is for, who it is for, how it is used or implanted, expected benefits, possible risks and side effects, alternatives, warnings, follow-up needs, and when to contact a healthcare professional. Avoid unexplained regulatory and clinical jargon.

Readability is an evidence question. The guidance expects the manufacturer to demonstrate that intended readers can understand the patient section, using an appropriate readability or user-testing method. Translation must preserve that clarity. A technically accurate translation that the intended patient cannot understand has missed the purpose.

Validation, languages, and publication

The manufacturer submits the draft SSCP to the notified body as part of the conformity assessment. The notified body checks consistency with the assessed technical documentation, validates the document, and uploads it to EUDAMED. The manufacturer remains responsible for the content and translations.

Prepare the master language version and the translations required for Member States where the device is made available. The notified-body process and EUDAMED workflow should be agreed early, including document naming, the master version, translation handling, and how updates will be validated and uploaded.

Keep the SSCP alive

The SSCP must remain consistent with the current clinical evaluation and technical documentation. Review it at least annually and whenever new clinical or post-market information materially changes its content. The natural review chain is PMCF and PMS data to the CER and risk-management file, then to the SSCP.

For class III and implantable devices, align the SSCP update with the PSUR and notified-body review cycle. Record why a new version was or was not needed. If a safety issue, new contraindication, changed clinical claim, or material evidence limitation appears, do not wait for a cosmetic annual update.

What this means for you, practically

1. Build the SSCP from traceable sources. Give every safety, performance, and clinical statement an owner and a source in the CER, risk file, PMS, PMCF, or IFU.
2. Separate the two audiences. Write the professional version for informed clinical decisions and the patient version for comprehension; do not solve readability by deleting important risk information.
3. Test patient understanding. Define the intended reader, method, acceptance criteria, findings, and revisions, and retain the evidence in the technical documentation.
4. Control translations and versions. Maintain one master, a translation matrix, notified-body status, EUDAMED status, and a clear relationship to the Basic UDI-DI.
5. Make updates part of the PMS cycle. Add an explicit SSCP-impact decision to CER, PMCF, PSUR, vigilance, and risk-management updates.

Read the official MDCG 2019-9 Rev.1 guidance.