Medical Device
Medical device is the legal term for products intended for one or more medical purposes under MDR (EU) 2017/745 Art. 2(1), whose principal intended action in or on the human body is not achieved by pharmacological, immunological, or metabolic means.
Typical medical purposes:
- Diagnosis, prevention, prediction, or treatment of disease
- Diagnosis, monitoring, or treatment of injury or disability
- Investigation, replacement, or modification of anatomy
- Contraception
Risk classification (MDR Annex VIII):
- Class I: low risk (e.g. non-sterile single-use gloves, walking aids, wound dressings)
- Class IIa: moderate risk (e.g. hearing aids, surgical needles)
- Class IIb: higher risk (e.g. defibrillators, surgical lighting)
- Class III: high risk (e.g. coronary stents, bone substitutes)
Medical devices are distinct from PPE: PPE protects the wearer; a medical device protects the patient or serves a medical function.
Frequently asked questions
What is the difference between a medical device and a PPE product?
A medical device is intended for medical purposes and primarily protects the patient (MDR). PPE protects the wearer against workplace risks (PPE Regulation). Some products - such as chemotherapy gloves - must comply with both frameworks simultaneously.
What is the difference between a medical device and a medicinal product?
The principal mechanism: medicinal products achieve their effect pharmacologically, immunologically, or metabolically. Medical devices achieve their effect by physical, mechanical, or chemical means (without a principal pharmacological action). This distinction is regulatorily critical in borderline cases.