What is medical device qualification?
Medical device qualification is the process of determining whether a product meets the definition of a medical device in a particular jurisdiction.
Determining whether a product qualifies as a medical device is crucial for manufacturers, as this affects the product development pathways and commercial opportunities available. Manufacturers must assess their products to ascertain whether they fall under the definition of a medical device in the jurisdiction where they intend to market and sell the product. It is also important for healthcare providers to know how a medical device product is regulated and the certifications required for its safe and effective use.
Key factors to consider in medical device qualification
- Definition of a Medical Device: Manufacturers should start by consulting the regulatory definitions provided by the relevant regulatory authorities in the target market. Every authority’s definition can be found on its website or within regulatory legislation. Manufacturers should also consult guidance documents and resources provided by regulatory authorities. These documents often clarify the definition of medical devices and how to classify products.
- Intended purpose: Manufacturers should consider the product’s intended purpose(s). If the product is intended for a medical purpose, it is more likely to be classified as a medical device. This includes products designed to diagnose, monitor, treat, or prevent disease or medical conditions. The claims made by the manufacturer in product labelling, advertising, and promotional materials are significant. If the manufacturer makes medical or healthcare benefits claims, it may lead to classification as a medical device.
- Mode of Action: How the product achieves its intended purpose is also important. If the product achieves its intended purpose through physical or mechanical means, it may be more likely to be considered a medical device. Generally, definitions exclude products that achieve their intended purpose through pharmacological means (these products are regulated differently).
- Consultation with Regulatory Authorities: In some cases, consulting with the relevant regulatory authority may be necessary to formally determine a product’s qualification and classification, especially if the information is uncertain.
It’s important to note that the qualification of a product as a medical device can vary from one jurisdiction to another, and the regulatory landscape may change over time. Therefore, manufacturers should keep updated with the latest regulations and guidance in the regions where they plan to market their products. Misclassifying a product can have legal and regulatory consequences, so seeking legal and regulatory advice when there is uncertainty is advisable.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- Medical device definition: Chapter I, Article 2: Definitions (1)
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- in vitro diagnostic device definition: Chapter I, Article 2: Definitions (2)
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
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.
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.
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.
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.
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.