Get the free Classification of medical devices - European Commission
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Application for performance/change/extension of a conformity assessment
procedure in accordance with Council Directive 90/385/EEC (AID)
Manufacturer:
Application identification:
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How to fill out classification of medical devices
How to fill out classification of medical devices
01
To fill out the classification of medical devices, follow these steps:
02
Identify the medical device and its intended use.
03
Determine the risk associated with the medical device.
04
Refer to the regulatory guidelines or standards specific to your country.
05
Assess the device's design, manufacturing processes, and materials used.
06
Classify the medical device according to the predetermined classification criteria.
07
Document the classification decision and ensure it complies with the regulations.
08
Keep accurate records of the classification process for future reference or audits.
Who needs classification of medical devices?
01
Medical device manufacturers need classification for regulatory compliance purposes.
02
Regulatory authorities require classification to ensure safety and effectiveness of medical devices.
03
Healthcare professionals rely on device classification to make informed decisions regarding device selection and usage.
04
Patients and consumers benefit from classification as it helps identify the risk level associated with medical products.
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What is classification of medical devices?
Classification of medical devices is a system that categorizes medical devices based on the level of risk associated with their use.
Who is required to file classification of medical devices?
Manufacturers of medical devices are required to file classification of their products.
How to fill out classification of medical devices?
Classification of medical devices can be filled out by providing information about the device's intended use, design, materials, and potential risks.
What is the purpose of classification of medical devices?
The purpose of classification of medical devices is to ensure appropriate regulatory controls are applied based on the level of risk associated with the device.
What information must be reported on classification of medical devices?
Information such as device description, intended use, technological features, and risk assessment must be reported on classification of medical devices.
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