Module 15 Presentations

10/04/2024

MDR Requirements relating to SSCPs

Article 32

*Not fully functional yet: SCCP available upon request

• Applicable to Class III and implantable devices • Clear for the intended user (healthcare professional) and, if relevant, to the patient

• Publically visible via EUDAMED database* • Submitted as part of technical documentation for review by notified body • Validated and uploaded to EUDAMED by the notified body • Referenced in label/IFU – GSPR 23.4(d) refers to the link to the SSCP appearing on the IFU

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

5

MDR Requirements relating to SSCPs

SSCP minimum content (Article 32): • Identification of device and manufacturer (including UDI and SRN) • Intended purpose, indications, contraindications and target population • Device description + accessories • Possible diagnostic or therapeutic alternatives • Compliance with harmonised standards and CS • Summary of CER and PMCF • Suggested profile and training for users • Information on residual risk and undesirable effects, warnings and precautions

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

6