Module 15 2022

5/19/2022

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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Requirements for Lay Persons

Lay Persons

GSPR 22: Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons Design and manufacture must : • Take account of : • skills and means available

Protection against risk

• Variations in the lay person’s technique and environment • Information/instructions easy to understand and apply • Ensure safe use (with training) • Reduce risks of injury (cuts) and risk of user error • Include a procedure to verify the device will perform as intended • Warning if the device fails to provide a valid result

GSPR 23.4 Instructions for use (w) for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional

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