The PMCFR and the SSCP are two distinct post-market deliverables that are frequently confused. The confusion is understandable — both address post-market clinical safety and performance — but their objectives, their content and their intended recipients are different.
The PMCFR: the internal report on PMCF activities
The post-market clinical follow-up report (PMCFR, Post-Market Clinical Follow-up Report) is the periodic document that presents the results of the activities carried out under the PMCF plan.
Its content. Data collected since the last report (complaints, registry data, survey results, new publications on comparable devices), a critical analysis of this data against the clinical gaps identified in the CER, conclusions on safety and performance, and actions triggered where applicable (update of the CER, revision of the PMCF plan, initiation of an FSCA).
Its function. The PMCFR feeds directly into the CER when it is updated. It is the operational link between post-market data collection and ongoing clinical evaluation.
Its frequency. Defined in the PMCF plan, it must be consistent with the device’s risk level and the gaps to be addressed. At least annual for implantable and class III devices (Article 61(11)). For other classes, it must remain consistent with that of the PSUR, which includes the main PMCF findings: at least annually for class IIb, at least every two years for class IIa (Article 86).
Its recipient. It is an internal document of the manufacturer, kept in the technical documentation. It is not published in EUDAMED.
The SSCP: the public document for healthcare professionals
The summary of safety and clinical performance (SSCP, Summary of Safety and Clinical Performance) is defined by Article 32 of the MDR. It is mandatory only for implantable devices and class III devices.
Its function. The SSCP is a public document, accessible via EUDAMED. It is intended for healthcare professionals and potentially for patients. Its purpose is to present, in accessible language, the essential information on the device’s safety and clinical performance that enables professionals to make informed decisions.
Its content. Description of the device and intended use, indications and contraindications, summary of the demonstrated clinical performance, summary of safety data (incidents, FSCA, post-market data), information on ongoing or past revisions, and contact details of the manufacturer and the EC REP.
Validation by the notified body. The SSCP is reviewed and approved by the notified body before its publication in EUDAMED. This validation is a step to be factored into the certification timeline.
The patient version. A part written in language accessible to patients is expected for implantable devices for which an implant card is provided and for class III devices intended to be used directly by patients (Article 32(1); MDCG 2019-9 Rev.1). This is a requirement the manufacturer must anticipate, not a possible request from the notified body.