Summary of Safety and Clinical Performance (SSCP)

MDR Reference: Article 32; Annex II, Section 6.3
BPG Rev.4 Reference: Section 6.3.5 (pp. 85-86)
Document Code: AII-S6-SSCP
Responsible Party: CRO
Service Mode: Write only

Applicability

Required for: All Class III and implantable devices (excluding custom-made)
Not required for: Class I, Class IIa non-implantable, Class IIb non-implantable

Requirements Checklist

Content (per MDCG 2019-9 and Article 32)

[ ] All information traceable to the technical documentation
[ ] PDF format, printable and searchable
[ ] Template per MDCG 2019-9 followed
[ ] NB language preference confirmed

Healthcare Professional Part

[ ] Device identification and intended purpose
[ ] Indications, contraindications, target population
[ ] Description of the device
[ ] Summary of clinical evaluation (with objective evidence)
[ ] Residual risks and quantification of risks (Section 4)
[ ] Alternative treatments
[ ] Suggested training/experience for users
[ ] Profile and training of evaluators
[ ] References and date of latest revision

Patient/Layperson Part

[ ] Required for: Class III devices used directly by patient, implantable devices with implant card (Article 18)
[ ] Considered for: All other applicable devices (justification required if not provided)
[ ] Patient-appropriate terminology throughout
[ ] Layout per MDCG 2019-9 patient section template
[ ] Example statements from MDCG 2019-9 considered
[ ] Readability assessment performed and evidence provided

Updates

[ ] Reviewed at least annually (coinciding with PMCF report and PSUR updates)
[ ] Updated when clinical/safety information changes
[ ] Healthcare professional and patient version kept aligned
[ ] Consideration of informing HCPs and patients of updates

EUDAMED Upload

[ ] Validated SSCPs uploaded to EUDAMED by NB after TD assessment
[ ] For Class IIa/IIb implantable WET: unvalidated SSCPs for non-representative devices also uploaded

Key Regulatory References

MDR (EU) 2017/745, Article 32
MDR (EU) 2017/745, Article 18 (Implant card)
MDCG 2019-9: SSCP guidance and templates
MDCG 2021-11: Device type classification for EUDAMED
Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 6.3.5

Common Pitfalls (from BPG Rev.4)

Risk quantification not included in SSCP Section 4
Layperson section written in regulatory/QMS language (not patient-readable)
SSCP not using MDCG 2019-9 template
Incomplete summary of clinical evidence (insufficient quantity/quality)
Incomplete or missing alternative treatment information
SSCP content deviating from IFU or patient information leaflet

Dependency

SSCP is a Phase 3 deliverable:

Depends on CER (clinical evidence summary), RMR (risk information), IFU (labelling alignment)
Must be aligned with all other labelling (1:1 alignment required)
Annual updates triggered by PMCF report and PSUR findings