Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective.
Rosanna TarriconeOriana CianiAleksandra TorbicaWerner B F BrouwerGeorges ChaloutsosM Bradley DrummondNicolas MartelliUlf PerssonReiner LeidlLes LevinLaura Sampietro-ColomRodney S TaylorPublished in: Expert review of medical devices (2020)
Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.
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