Core39: Medical device

🩺 High-yield / 要点：Medical devices have a specific medical purpose but usually act by physical action or software/in silico function, not by pharmacodynamic drug effects.

Definition / 定義

• Under MDR / Medical Device Regulation, a medical device is used for medical purposes such as:
  • Diagnosis.
  • Monitoring.
  • Treatment.
  • Alleviation.
  • Other medical purposes.
• Medical devices generally do not have pharmacodynamic effects.
• They act mainly by:
  • Physical/mechanical action.
  • In vitro diagnostic function.
  • Medical software / in silico function.

Device classes / 医療機器クラス

Class	Risk	Examples
Class I	Low risk	Tongue depressor, wheelchair, spectacles
Class IIa	Medium risk	Hearing aids
Class IIb	Medium to high risk	Ventilators, infusion pumps
Class III	High risk	Pacemakers, defibrillators, implanted prosthetics, breast implants

Key distinction / 薬との違い

• A product used for fitness alone is not necessarily a medical device.
• A product used for a medical purpose, e.g. monitoring a disease parameter, can be a medical device.
• Medical devices may overlap with:
  • In vitro diagnostic devices.
  • Medical aids.
  • Nursing/caring technical devices.

Remember / 覚え方

• Medical purpose + no pharmacodynamic effect = medical device
• Higher class = higher risk
• Class III = implantable/life-supporting high-risk devices