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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg 44ZO

reg 44ZO Reports received by the Secretary of State

(1) The Secretary of State must record reports of incidents involving devices. (2) If the Secretary of State notifies a manufacturer about a reported incident, the manufacturer must consider whether the incident is a serious incident and take action in accordance with this Part. (3) If the manufacturer of the device considers that the incident is not a serious incident, the manufacturer must provide an explanatory statement to the Secretary of State as soon as possible. (4) If the Secretary of State notifies the manufacturer that the Secretary of State does not agree with an explanatory statement provided under paragraph (3), the manufacturer must take action in accordance with this Part as if the manufacturer considered the incident to be a serious incident.

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