MDR Medical Device Classifier-Medical Device Classification
Simplifying MDR compliance with AI
Describe the medical device you are seeking to classify under MDR regulations.
What is the intended use and duration of use for your medical device?
Is your medical device invasive or non-invasive, and how does it interact with the body?
Does your device incorporate any active components or software that influence its use?
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Introduction to MDR Medical Device Classifier
The MDR Medical Device Classifier is a specialized tool designed to assist manufacturers, regulators, and healthcare providers in determining the correct classification of medical devices under the European Union's Medical Device Regulation (MDR). This classifier utilizes the specific rules and definitions outlined in the MDR's Annex VIII, encompassing various criteria such as the device's intended purpose, duration of use, whether it's invasive or non-invasive, and its interaction with the human body. For instance, a manufacturer developing a new surgical instrument can use this classifier to understand whether their product falls under Class I (low risk) or Class IIa/b or III (higher risk), based on factors like whether it's intended for transient use or if it's a reusable surgical instrument. Powered by ChatGPT-4o。
Main Functions of MDR Medical Device Classifier
Classification Guidance
ExampleDetermining the class of a disposable soft contact lens intended for correcting vision.
ScenarioA manufacturer needs to classify a new contact lens product. The classifier can guide through rules related to non-invasive devices, considering aspects like the lens's contact with the eye (a body orifice) and its intended short-term use, leading to a possible Class IIa classification.
Regulatory Compliance Assistance
ExampleEnsuring a heart valve implant meets the necessary regulatory class for EU market entry.
ScenarioFor a company developing a new heart valve, the classifier can navigate through rules concerning implantable devices and those specifically intended for use in direct contact with the heart, indicating a Class III classification due to the high-risk nature and critical interaction with central circulatory system.
Educational Tool
ExampleProviding training on MDR classification rules to new regulatory affairs staff at a medical device company.
ScenarioA medical device company uses the classifier as part of an onboarding process for new employees in the regulatory affairs department, helping them understand the complexities of MDR classification through real-life examples and scenarios.
Ideal Users of MDR Medical Device Classifier Services
Medical Device Manufacturers
Manufacturers benefit significantly, as accurate classification is crucial for regulatory approval, market strategy, and compliance. The tool helps them navigate the complex MDR rules, ensuring their products are correctly classified from the outset.
Regulatory Affairs Professionals
These professionals are responsible for ensuring that their company's products comply with all regulatory requirements. The classifier serves as an invaluable reference and training tool, enabling them to stay updated on classification rules and apply them accurately.
Healthcare Providers
Providers use the classifier to understand the regulatory classifications of devices they might use, influencing procurement decisions and compliance with hospital or clinic policies regarding device safety and efficacy.
How to Use MDR Medical Device Classifier
1
Access the classifier freely at yeschat.ai, no sign-up or ChatGPT Plus required.
2
Describe your medical device in detail, including its intended use, duration of use, and any contact it may have with the body.
3
Navigate through the classification rules provided in the interface to identify the relevant definitions and rules applicable to your device.
4
Interact with the AI by asking specific questions or providing information about your device to refine the classification.
5
Request a final classification report, which includes a summary of the device description, evaluation criteria, and the concluded classification.
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Frequently Asked Questions About MDR Medical Device Classifier
What is MDR Medical Device Classifier?
MDR Medical Device Classifier is an AI-powered tool designed to assist manufacturers and developers in classifying their medical devices according to the EU's Medical Device Regulation (MDR) framework.
Can it classify any type of medical device?
Yes, the classifier is capable of classifying a wide range of medical devices, from non-invasive devices to active implantable devices, based on the detailed information provided by the user.
How accurate is the classification?
The accuracy depends on the completeness and specificity of the information provided about the device. The tool uses the latest MDR classification rules to ensure up-to-date compliance.
Can I get a classification report?
Yes, upon completion of the classification process, users can request a downloadable PDF report that summarizes the device description, evaluation criteria, and the final classification.
Does this tool classify devices under FDA regulations as well?
While primarily focused on EU MDR classification, the tool can also assist in classifying devices under FDA regulations, guiding users to applicable rules and considerations.
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