Is it a medical device?

The regulations’ definitions of a medical device cover a broad area, including devices that are intended for use within areas of healthcare and self-care.

The purpose of the device is the determining factor

It is the manufacturer’s purpose for the device which determines whether the device is a medical device. In some cases, the mode of action of the device (how it works) may also be significant. What the device is intended for is defined in in, inter alia, the labelling, instructions for use and marketing. An assessment of whether the regulatory framework for medical devices must be followed must be carried out by the manufacturer for each product. Two devices that are similar in appearance may have differences which mean that they are subject to different regulations.

Definition of a medical device

A medical device can be an instrument, apparatus, appliance, software, implant, reagent, material or other article. The condition is that a medical device must be used on humans and have one or more of the following medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

The distinction between medical devices and medicinal products is that a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means. However, a medical device may be assisted in its function by such means.

The EU Regulation on in vitro diagnostic devices (IVDR) covers devices which are intended for the investigation of samples taken from the human body, in order to provide information:

• on a physiological or pathological process or state,
• on congenital physical or mental impairment,
• on predisposition to a medical condition or disease,
• which make it possible to determine safety and compatibility with potential recipients,
• which make it possible to predict treatment response or treatment reactions,
• make it possible to define or monitor therapeutic measures.

The EU’s MDR also includes:

• Accessories to medical devices
• Devices intended for the control or support of conception
• Devices listed in Annex XVI of the MDR
• Containers for samples for in vitro diagnostic investigation
• Products specifically intended for the cleaning, disinfection or sterilisation of medical devices and devices covered by the regulations.

Examples of areas of devices which border the regulatory frameworks for medical devices:

• national medical information systems (NMI)
• medicinal products
• cosmetic products
• food
• personal protective equipment
• biocides.