Medical device qualification
Qualification is the process of determing whether a product meets the definition of a medical device, as defined by regulatory requirements.
The intended purpose of a medical device is a fundamental concept that drives its qualification within regulatory frameworks. The intended purpose is a concise statement defining the use for which the device is intended according to the manufacturer’s claims, which can encompass diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or disability.
The intended purpose is detailed in the device’s labelling, instructions for use, and promotional materials. It includes specific information about:
- Intended use(s)
- Indication(s)
- Intended user(s)
- Setting(s)
- Contraindications and warnings
The intended purpose significantly influences the device’s risk assessment, regulatory requirements, and market approval process.
Risk classification
Regulatory authorities use the intended purpose for classifying medical devices into different categories. Risk classification is based on the potential risks the device poses to patients and users, which is directly related to its intended purpose.
Conclusion
The intended purpose of a medical device is a cornerstone of its regulatory pathway, influencing both its qualification and classification. By defining the specific medical claims, target population, mode of action, and clinical context, the intended purpose guides the risk assessment and regulatory requirements, ensuring that devices entering the market are safe, effective, and fit for their intended use.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
European Union (EU):
Medical Device Coordination Group (MDCG) guidance documents on medical device classification:
- MDCG 2021-24 Guidance on classification of medical devices
- MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3
- Helsinki Procedure for borderline and classification under MDR & IVDR
United States of America (USA):
Food and Drug Administration (FDA) guidance documents:
Australia:
Therapeutic Goods Administration (TGA) classification guidance:
China:
National Medical Products Administration (NMPA) guidance in English:
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- Medical device definition: Chapter I, Article 2: Definitions (1)
- Medical device classification: Chapter V, Section 1, Article 51: Classification of devices and ANNEX VIII
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- in vitro diagnostic device definition: Chapter I, Article 2: Definitions (2)
- in vitro diagnostic device classification: Chapter V, Section 1, Article 47: Classification of devices and ANNEX VIII
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
- Medical device definition: Section 201(h) of the Food, Drug, and Cosmetic Act
- Medical device classification: Code of Federal Regulations Title 21, parts 800 - 1299, PART 860 Medical Device Classification Procedures
Classification: The process of categorising devices into different classes based on their intended use, level of risk to patients and users, and regulatory controls necessary to ensure safety and effectiveness.
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Indication of Use: A concise statement specifying the medical conditions or purposes for which the medical device is intended to be used, as approved by regulatory authorities.
Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Mode of Action: The means by which a device achieves its intended therapeutic or diagnostic effect.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Qualification: The process of determining whether a product meets the definition of a medical device in a particular jurisdiction.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.