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Who needs mdcg 2021-24 guidance on?

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The MDCG 2021-24 guidance is needed by:
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- Medical device manufacturers
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- Regulatory professionals involved in medical device development and approval process
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- Quality assurance personnel responsible for ensuring compliance
05
- Regulatory authorities responsible for reviewing and assessing medical device applications
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- Healthcare professionals or organizations involved in selecting, purchasing, or using medical devices
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- Anyone interested in understanding and complying with the latest regulatory guidelines for medical devices.

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mdcg 24 guidance provides guidance on the implementation of the Medical Device Regulation (MDR) in Europe.
Manufacturers of medical devices who wish to market their products in Europe are required to follow mdcg 24 guidance.
mdcg 24 guidance should be filled out according to the specific requirements outlined in the document, including providing detailed information about the medical device being marketed.
The purpose of mdcg 24 guidance is to ensure that manufacturers comply with the regulations set forth in the Medical Device Regulation and to provide clarity on how to do so.
Information such as the classification of the device, its intended use, its design and labeling, and any performance data must be reported on mdcg 24 guidance.
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