This template defines what to include in a Summary of Safety and Clinical Performance (SSCP) so we can publish a clear, EU MDR-aligned public summary for healthcare professionals and patients.

• Capture device identification: trade name, manufacturer details, SRN, Basic UDI-DI, and UDI-DI

• Document medical device nomenclature using EMDN code/description

• State device class and MDR Annex VIII rule, plus year of first CE marking

• Define intended purpose, indications, target population, contraindications, and limitations (from IFU)

• Provide a comprehensive device description: operating principles, patient-contacting materials, sterilization/single-use, variants/accessories

• Summarize residual risks/undesirable effects with quantitative rates and timepoints; include warnings/precautions

• Record FSCA/FSN history and summarize clinical evaluation, PMCF, and PMS conclusions (incl. benefit–risk)

Your needs:

• SSCP for medical devices

• SSCP for medical devices for MDR compliance

• Reduce rework, strengthen consistency, and lower audit risk across clinical and PMS inputs

Use this SSCP template when preparing the public SSCP package and maintaining it across revisions; it complements (and does not replace) the IFU and clinical documentation.

Key requirements covered include defining Basic UDI-DI (the identifier linking devices to one SSCP) and clinical risks (patient-specific undesirable effects that must be quantified).

• Device and manufacturer identifiers, including SRN and Notified Body details

• Intended purpose/indications/contraindications aligned to the IFU

• Device description elements impacting safety/performance (materials, mode of action, sterilization)

• Residual risk table with rates and timepoints, plus warnings/precautions

• FSCA/FSN summary (or confirmation of none)

• Clinical evidence summary: investigations, literature review, PMCF, and PMS findings

• Benefit–risk conclusion, alternatives, and user training expectations

At Lexqara, we help compile SSCP-ready content from your CER, PMS/PMCF plans, and risk management, and we quality-check traceability and consistency. Explore our Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy support [https://lexqara.com/services/regulatory-strategy], and anchor requirements to EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template and request a short gap assessment.