Does the Product Meet the Definition of a Medical Device?The first step is to determine if your product meets the definition of a medical device under the EU Medical Device Directive (MDD) 93/42/EEC definition:
What Is A Medical Device?‘medical device’ means any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- the investigation, replacement or modification of the anatomy or a physiological process,
- control of conception,
What is the Intended Use of the Product?You need to define the intended use of the product. Ask yourself –
- what medical condition is the product intended to diagnose or treat?
- what is the mode of action of the product; who is the intended user (layperson / professional), and what patient population will the product treat?
What Is the Risk Classification of the Product?The next step is to determine what risk classification the product falls in to. Annex IX of the MDD outlines 18 Rules from which you can determine the classification of your product. Examples of factors that influence the classification include the degree of invasiveness; anatomical location and length of time that the product is in contact with the body; whether or not the device is sterile or has a measuring function; whether the device incorporates a medicine. There are 4 classification categories:
- Class I is the lowest risk category;
- Class IIa is low to medium risk;
- Class IIb is medium to high risk, and
- Class III is the highest risk category.