Module 15 Presentations

4/15/2024

Classification

Classification

New Rules • Rule 11 software • Rule 19 nanomaterials

Based on risk and intended purpose

Class III

• Rule 20 administration by Inhalation • Rule 21 absorption/local dispersion • Rule 22 Active closed loop devices Changes • Devices containing active substances (Rule 14) • Up - classifications e.g. meshes, spinal implants, devices in direct contact with the heart

Class IIb

High

Class IIa

Class I

Risk

sterile measuring reusable

Low

Class I

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© NAMSA 2021

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General Safety and Performance Requirements

GSPRs

Key Changes Multiple new requirements: MDD 13 ERs vs MDR 24 GSPRs

Key New requirements and nuances: • Label and Instructions for use • Devices to be used by laypersons • Electronic programmable systems and software • Devices containing CMRs • Devices absorbed/locally dispersed

More detail required: “justification, validation and verification”

Stronger links to the evidence: • “precise identity”

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© NAMSA 2021

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