- Published
- Updated
- Sources checked
A summary of safety and clinical performance should remain readable and consistent with the evidence supporting the device.
SSCP consistency — Define the regulatory scope
MDR Article 32 defines the applicable SSCP requirement for implantable and class III devices, with specified exclusions. MDCG SSCP guidance supports structure and presentation.
SSCP consistency — Build the working record
Build a crosscheck between intended purpose, residual risks, alternatives, PMCF findings, instructions for use and clinical evaluation. Identify audiences and the applicable validation and publication workflow without presenting the summary as advertising.
SSCP consistency — Check before release
- Match the device and certificate scope.
- Compare benefit and residual risk language.
- Track revisions across the underlying documents.
SSCP consistency — Record the decision and handover
Resolve differences with clinical, regulatory and labelling owners. Retain the validation and release evidence applicable to the device and check the current EUDAMED arrangements before updating the public record.
Frequently asked questions
- Does every medical device need an SSCP?
- No. Determine whether Article 32 applies, including its exclusions.
- Can the SSCP promise better outcomes than the CER?
- No. Public claims must remain supported and consistent with the clinical evaluation.