Oct 8, 2019
The European Commission has issued new guidance for manufacturers of implantable medical devices to develop Summaries of Safety and Clinical Performance (SSCP) based on Medical Devices Regulation (MDR) requirements.
MDCG Guidance 2019-9, Summary of safety and clinical performance; A guide for manufacturers and notified bodies, has been published. The document provides a clear rationale, including reference to articles and annexes, it helps in understanding most of the requirements and it provides a template for this document.
There has been criticism in the press and by medical professionals regarding getting a proper understanding of the risks and benefits of certain devices. The SSCP is intended to provide that extra understanding.SSCP requirements laid out in Article 32 of the MDR
Article 32 of the MDR (EU) 2017/745 ) requires the creation of an SSCP for all implantable devices.
- Rule 8 of Annex VIII places devices that are implantable in teeth in Class IIa.
- Devices used in direct contact with the heart, the central circulatory system or the central nervous system are considered Class III.
- Devices that have a biological effect or are wholly or mainly absorbed; devices that are intended to undergo chemical change in the body; intended to administer medicinal products; or are active implantable devices or their accessories are Class III.
- Breast implants or surgical meshes; total or partial joint replacements (ancillary components exempted); spinal disc replacement implants; or are implantable devices that come into contact with the spinal column (ancillary components exempted) fall under Class III.
- All other implantable devices are in Class IIb.
SSCPs must be created for all these devices.
Exhibitor Data Sheet