Rules on device company inspections/audits
Rules on assessing products in combination with above
Procedural recommendations on expert evaluation of quality, safety and efficacy of the marketing authorization application for a medical device
Classification criteria for devices, IVDs and lab products, cosmetics
Rules on bundling several devices under a single nomenclature
Rules on the regulation of constituent components and accessories
Documents and procedures for making a registration submission
Voluntary standards that ensure device conformity
Requirements on each of: sales; disposal; maintenance*
Competency and training levels of specialists at authorized expert organizations*

*Development timeframes are given as 2018 (all others are 2016).

Source: IMEDA

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