07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
Oct 22, 2019
(blog) New European MDCG guidance on MDR Summary of Safety and Clinical Performance (SSCP) rules
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.
New RAMS digital medical device RA/QA management system now available
Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite (RAMS) platform to provide automated, efficient and cost-effective regulatory affairs and quality management support for medical device companies.
RAMS 2.0 features an expanded set of digital tools and capabilities to enable medical device as well as combination product manufacturers to more effectively manage and monitor registration and compliance activities across more than 20 markets worldwide.
Key features of RAMS 2.0 include weekly insights and regulatory intelligence updates from Emergo by UL consultants, interactive planning tools for FDA 510(k) applicants, and searchable databases of regulatory documents and resources covering all markets in which Emergo by UL is active.
Until December 31, 2020, manufacturers may sign up for RAMS 2.0 accounts at no charge to discover the benefits of digital RA/QA management.
Manufacturers may learn more about our RAMS 2.0 launch in our press release.
Emergo is a leading consultancy with 2,800+ medical device and IVD clients worldwide. We maintain offices in 25 countries, offering a wide range of compliance and market access services. We assist companies with global regulatory strategy, device registration, QMS compliance and in-country regulatory representation services.