According to Regulation (EU) 2017/745, a medical device is any instrument, apparatus, implant, or other product intended by the manufacturer to be used for diagnosis, prevention, monitoring, therapy, alleviation of diseases, injuries, or disabilities. Regulation (EU) 2017/745 requires that all Medical Devices (MD) be marked according to their class, meeting the essential requirements described therein. Compliance with Regulation (EU) 2017/745 can be demonstrated by meeting the requirements described in the harmonized standards to Directive 93/42 EEC, as the list of harmonized standards to Regulation (EU) 2017/45 has not yet been issued.
Based on the intended use and associated risks, all our medical devices are classified as follows:
Non-invasive devices
Temporarily used invasive devices
All invasive devices related to body orifices, other than surgical invasive devices, not intended to be connected to an active device or intended to be connected to a Class I active device for temporary use
Invasive devices related to body orifices, other than surgical invasive devices, not intended to be connected to an active device or intended to be connected to a Class I active device
All surgical invasive devices intended for temporary use
All active devices intended to administer medicines
For all medical devices, such as gloves, the reference standard is EN 455 (1-2-3-4), which identifies and imposes minimum performance levels regarding dimensional and qualitative characteristics.
Disposable medical gloves. Absence of holes: requirements and testing. (The standard defines the test method for determining the absence of holes in disposable examination gloves and specifies the AQL “for absence of holes” of a sampled batch according to ISO 2859-1 must be ≤ 1.5).
Disposable medical gloves. Absence of holes: requirements and testing. (The standard defines the test method for determining the absence of holes in disposable examination gloves and specifies the AQL “for absence of holes” of a sampled batch according to ISO 2859-1 must be ≤ 1.5).
Disposable medical gloves. Requirements and testing for determining shelf life.
Medical Devices: application of risk management to Medical Devices.
Information provided by the manufacturer of Medical Devices.
Symbols to be used in the labeling of Medical Devices.
