Description: Implant cards require "type" of product - this is explained in MDCG 2021-11. The EMDN has category and group and 5 types. Sampling of TD is performed by Notified Bodies based on generic device group and device subcategories. PSURs and PMCFR can be written for types of device.
Are all these types of type the same? If not, how do they differ?
How do model numbers, reference numbers or catalogue numbers fit in? How do these relate to the nomenclature used in other regions (such as Canada - e.g. identifier, control #)?
This session will review the various types of type, how they relate to each other, to generic device groups and device sub-categories, to EMDN and to model, reference and catalogue number and discuss the implications of this (and various groupings on, for example, certificate structure, TD structure including PSUR and PMCFR, EMDN assignment, sampling by Notified Bodies, grouping under a single BUDI and relationship to SSCPs).
(Note to RAPS: Suggest this be a solution circle, 30 min session)
Learning Objectives:
Learn how to distinguish between various types of type (e.g. on implant card, in EMDN)
Learn how these types relate to generic device groups and device subcategories (used in sampling of TD and in defining similar devices for CERs)
Relate all this to model #, reference #, catalogue # and terminology used (e.g. in Canada).
Understand the possible implications of grouping devices in certain ways (types, BUDI etc)