Ce Mark Medical Device Labeling Requirements

Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system.

Ce mark medical device labeling requirements.

There are 4 classes class i class iia class iib and class iii. The full list of these. Ce marking applies to products ranging from electrical equipment to toys and from civil explosives to medical devices. The directives outline the safety and performance requirements for medical devices in the european union eu.

Obtain ce marking and iso 13485 certificates from your notified body. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. Ce mark locations include 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.

There are two major areas of confusion about the translation requirements when ce marking a product for export to the eu states. Eu foreign language labeling requirements. Prepare a declaration of conformity doc which states that your device complies with the appropriate directive. Ce marking routes of class i medical devices.

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. They usually constitute low to medium risk. European union ce marking the mark must be accompanied by the id of the notified body when conformity assessment procedures are required. The full list of these product categories is below.

This makes the ce marking recognizable. Medical devices covered by the directives must bear the ce mark. Ce mark medical devices labeling requirements. Medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc.

The retail sales packaging. Patients should use them for a short term period any less than 30 days. It shows that the device is fit for its intended purpose stated and meets. 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.

Class iia medical devices. The device or its sterile package. Each medical device is classified into the risks involved.