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10 Posts in this encyclopedia categoryManufacturer
"Manufacturer means any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under his own name or trademark." (Source: Blue Guide).
Medical Device
Medical devices are products with a medical purpose that are intended by the manufacturer for use in humans. They are subject to the Medical Devices Regulation / MDR (EU) 2017/745 and are divided into different classes depending on the degree of risk: Class I, Class IIa, Class IIb, Class III.
Medical device class II a
These are (mostly) devices that are used on the body for a short period of time (usually 60 minutes to 30 days). Certification via a Notified Body is mandatory. Examples are sterile surgical gloves, catheters, etc.
Medical device class II b
These are devices that are slightly more complex than IIa devices and are often used in the body for more than 30 days. Certification via a Notified Body is mandatory. Examples are infusion pumps, dental implants, etc.
Medical device class III
These are medical devices that are used directly on the central circulatory or nervous system or contain a drug. Certification via a Notified Body is mandatory. Examples of this are pacemakers, hip prosthesis
Medical devices class I
Class I medical devices are mostly non-invasive devices that have no effect on the human body and have a very low risk.
Medical devices class I m
Class I m medical devices correspond to those of Class I medical devices, but they also have a measuring function. The measuring function must be certified by a Notified Body. Example: Medicine cups with measuring function, stethoscopes, thermometers.
Medical devices class I s
Class Is medical devices correspond to those of Class I medical devices, but they are placed on the market in a sterile state. Sterility must be certified by a Notified Body.
Medical Devices Regulation / MDR (EU) 2017/745
Requirements for medical devices, placing on the market, making available on the market and putting into service are regulated for the EU in Regulation (EU) 2017/745.