Ce Mark Medical Device Labeling Requirements

The directives outline the safety and performance requirements for medical devices in the european union eu.

Ce mark medical device labeling requirements.

Patients should use them for a short term period any less than 30 days. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. Medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc. European union ce marking the mark must be accompanied by the id of the notified body when conformity assessment procedures are required.

This makes the ce marking recognizable. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. Ce marking routes of class i medical devices. The ce mark is a legal requirement to place a device on the market in the eu.

Ce mark medical devices labeling requirements. There are two major areas of confusion about the translation requirements when ce marking a product for export to the eu states. Ce marking is an administrative marking that indicates conformity with health safety and environmental protection standards for products sold within the european economic area eea. Ce mark locations include ce mark.

There are 4 classes class i class iia class iib and class iii. They usually constitute low to medium risk. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. Each medical device is classified into the risks involved.

Class iia medical devices. The device or its sterile package. Ce marking applies to products ranging from electrical equipment to toys and from civil explosives to medical devices. The retail sales packaging.

The full list of these. Prepare a declaration of conformity doc which states that your device complies with the appropriate directive. The full list of these product categories is below. The obl also should review the oem s essential requirements checklist declaration of conformity and ce marking certificates if notified body involvement is necessary for ce marking.

Medical devices covered by the directives must bear the ce mark. It is not a quality indicator or a certification mark the ce marking is also found on products sold outside the eea that have been manufactured to eea standards. It shows that the device is fit for its intended purpose stated and meets.