Glossary · EU medical devices: MDR
Medical device (MDR)
Also known as: Medical device, Device (MDR)
Under the EU Medical Device Regulation (EU) 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for human beings for a specific medical purpose, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. It does not achieve its principal intended action by pharmacological, immunological or metabolic means, although such means may assist its function.
- EU
- MDR
In one sentence
Under the MDR, a medical device is a product the manufacturer intends for a medical purpose that doesn't act mainly by pharmacological or metabolic means.
Example
A wearable that the manufacturer markets for detecting atrial fibrillation is a medical device because of its stated medical purpose; the same hardware sold only for counting steps is not.
How it applies
- Intended purpose decides: Whether a product is a medical device follows from the manufacturer’s intended purpose as stated on the label, in the instructions for use, in promotional material and in the clinical evaluation. The regulatory term is close to the general notion of intended use.
- Mode of action: A product that achieves its principal intended action by pharmacological, immunological or metabolic means is a medicinal product, not a device. Borderline and integral products are handled as drug-device combinations.
- Also in scope: Devices for the control or support of conception, products for cleaning, disinfecting or sterilizing devices, accessories and the products without a medical purpose listed in Annex XVI.
- Subtypes: Software with a medical purpose is medical device software; devices for in vitro examination of specimens are IVDs and fall under the IVDR.
- Technical documentation: The device description in Annex II of the technical documentation states the intended purpose, users and patient population. That statement drives classification, the clinical evidence needed and the content of the IFU.
Medical device vs. medicinal product
The line is the principal mode of action, not the form of the product. A syringe or an inhaler is a device; the drug inside is a medicinal product regulated under Directive 2001/83/EC. Where both form a single integral product, Article 117 MDR links the two regimes.