Medical device classification

According to the MDR 2017/745, Article 2 – Definitions, medical device is

any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific 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, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.During the definition process the main question is what is the intended purpose of the medical device. If you can state that your device has the intended purpose within the rules stated above, then you can state that it is a medical device.

If you look through the Annex 8 – Classification rules, in my opinion, you need to look if the following rules are applicable for your device:

Rule 4

All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:

• class I if they are intended to be used as a mechanical barrier, for compression, or for the absorption of exudates
• class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent
• class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane, and
• class IIa in all other cases.This rule also applies to the invasive devices that come into contact with injured mucous membranes.

Rule 21

Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:

• class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose
• class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body
• class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities, and
• class IIb in all other cases

For more information, see:

• EU MDR Article 2 – Definitions - https://advisera.com/13485academy/mdr/definitions/
• EU MDR Annex 8 – Classification rules - https://advisera.com/13485academy/mdr/classification-rules/