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November 2022MEDICAL DEVICE GUIDANCE GN11: Guidance on the Declaration of Conformity Revision 1.3MEDICAL DEVICE GUIDANCENOVEMBER 2022CONTENTS PREFACE ........................................................................................................
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01
Read the instructions provided in the medical device guidance document.
02
Fill in all the required information accurately.
03
Provide details about the medical device being used or developed.
04
Include details about intended use, design, performance, and risks associated with the device.
05
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Who needs medical device guidance on?
01
Manufacturers of medical devices
02
Developers of new medical devices
03
Regulatory authorities overseeing medical devices
04
Healthcare professionals involved in using or prescribing medical devices
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What is medical device guidance on?
Medical device guidance is on the regulation and instructions for the development, manufacturing, and marketing of medical devices.
Who is required to file medical device guidance on?
Manufacturers, developers, and marketers of medical devices are required to file medical device guidance.
How to fill out medical device guidance on?
Medical device guidance can be filled out by providing detailed information on the device, its intended use, manufacturing process, and marketing strategy.
What is the purpose of medical device guidance on?
The purpose of medical device guidance is to ensure the safety and efficacy of medical devices for use by healthcare professionals and patients.
What information must be reported on medical device guidance on?
Information such as device classification, risk assessment, clinical data, labeling, and quality control measures must be reported on medical device guidance.
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