93/42/EC DIRECTIVE MEDICAL DEVICES
The European Medical Device Directive 93/42/EC is legislation on European Level applicable from 14/06/1993.
This directive has since been amended several times. The last substantial amendment of this directive was the version 2007/47/EC. With the transposition of this Directive into national law in each Member State of the European Community, this Directive became mandatory. (Read more)
Examples of Medical devices are:
- Distribution networks for medical gases (oxygen, compressed air, nitrous oxygen, …) and vacuum
- Scavenging system for anaesthetic gases
- Medical supply units (bed, ceiling)
- Oxygen concentrators
- Pressure regulators, valves, …
- Gasses such as nitrogen, carbon dioxide, …
- Hospital beds, dental chairs, …
- Bandages, gauze, cannulise, catheters, surgical gloves, electrodes, …
- Infusion pumps, injectors, needles, irrigation systems, surgical tools, …
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The nomenclature of the medical devices is described in the UMDNS codes (“Universal Medical Device Nomenclature System”) or the GMDNS codes (“Global Medical Device Nomenclature System”).
For the certification of this kind of products in accordance with the above mentioned directive, the manufacturer must draw up a technical file and the compliance of the products must be certified by a Notified Body. The manufacturer can choose to inspect the medical devices or to set up a certified quality assurance system.
For this, we can give you targeted advice concerning the preparation of the technical file and the quality assurance system, and provide customized training. Do not hesitate to contact us.