What is a medical device?
(and why understanding this definition is essential)
The official definition (Regulation (EU) 2017/745 - Article 2)
To summarize the definition given by article 2 of the regulation, a medical device is a product (hardware or software) that:
- is intended by the manufacturer to be used for medical purposes, such as diagnosis, prevention, monitoring, treatment, or compensation of a disease or disability;
- exerts its principal action without pharmacological, immunological or metabolic means ;
- may be a stand-alone device or an accessory (e.g. software to aid diagnosis, a dressing, an implant).
The manufacturer's medical intention is key: it is not the physical nature of the product, but the claimed use that determines whether it is a DM.
Some examples:
- A meditation app ➡️ Not a DM (general well-being)
- Diagnostic software ➡️ Yes, it's a DM
- A sterile dressing ➡️ Yes, also a DM
- A nicotine patch ➡️ No, medication (pharmacological action)
What about non-medical purpose devices?
The MDR regulation (Regulation (EU) 2017/745) also applies to certain non-medical purpose products, listed in Annex XVI, due to their risk profile close to DMs.
These include:
- Fancy contact lenses
- Cosmetic implants
- Filling substances (such as hyaluronic acid)
- Liposuction devices
- Lasers/UV for aesthetic treatments
- Non-medical brain stimulators
These products are now subject to MDR requirements, even without medical use, as they present risks comparable to those of medical devices.
Why is this definition so crucial?
Because it determines the product's entire regulatory lifecycle:
- The applicable legal framework
- Clinical requirements
- CE-marking, and
- The legal responsibilities of the manufacturer
Incorrect qualification can have serious consequences: refusal to market, sanctions, or legal problems.
Certeafiles can help you
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