Our EU MDR Medical Device Determination software tool allows you to identify if your product should be regulated as a medical device according to the EU MDR 2017/745 regulation
Welcome to the Patient Guard Medical Device Determination tool for the EU MDR (EU 2017/745) regulatory framework. To get started, answer the following series of questions relating to your product, and the software tool will identify if your product is a medical device or falls under the requirements as a medical device based on the definition in Article 2 of EU MDR 2017/745.
Previous Answers:
Is the product to be used for human beings?
Does the product have a medical purpose?
Is the product intended for diagnosis of disease, 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?
Is the product intended for prevention of disease, 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?
Is the product intended for monitoring of disease, 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?
Is the product intended for prediction of disease, 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?
Is the product intended for treatment of disease, 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?
Is the product intended for alleviation of disease, 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?
Is the product intended for diagnosis of an injury or disability, 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?
Is the product intended for monitoring of an injury or disability, 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?
Is the product intended for treatment of an injury or disability, 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?
Is the product intended for alleviation of or compensation for an injury or disability, 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?
Is the product intended for investigation of the anatomy, 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?
Is the product intended for modification of the anatomy, 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?
Is the product intended for investigation of a physiological or pathological process or state, 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?
Is the product intended for replacement of a physiological or pathological process or state, 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?
Is the product intended for modification of a physiological or pathological process or state, 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?
Is the product intended for control or support of conception?
Is the product intended for the cleaning, disinfection or sterilisation of devices?
Not a medical device under MDR EU 2017/745
Not a medical device under MDR EU 2017/745, if it falls within one of these categories then it will still need to be regulated under EU MDR 2017/745 despite it not having a medical purpose:
Contact lenses or other items intended to be introduced into or onto the eye.
Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
This product would be a medical device under MDR EU 2017/745, check out our Medical Device Classification tool to see what classification staus your medical device might be
Find out more about medical device compliance and regulations
Complete the form below and receive instant access.
Speak to one of our medical device consultants
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
