Ce Mark Medical Device Labeling Requirements

Obtain ce marking and iso 13485 certificates from your notified body.

Ce mark medical device labeling requirements.

They usually constitute low to medium risk. The full list of these product categories is below. Ce marking applies to products ranging from electrical equipment to toys and from civil explosives to medical devices. There are 4 classes class i class iia class iib and class iii.

The ce mark is a legal requirement to place a device on the market in the eu. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. 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.

It shows that the device is fit for its intended purpose stated and meets. There are two major areas of confusion about the translation requirements when ce marking a product for export to the eu states. This makes the ce marking recognizable. European union ce marking the mark must be accompanied by the id of the notified body when conformity assessment procedures are required.

Eu foreign language labeling requirements. The full list of these. Ce mark medical devices labeling requirements. Prepare a declaration of conformity doc which states that your device complies with the appropriate directive.

Class iia medical devices. The directives outline the safety and performance requirements for medical devices in the european union eu. Each medical device is classified into the risks involved. 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.

Ce marking routes of class i medical devices. Medical devices covered by the directives must bear the ce mark. The device or its sterile package. Medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc.

The medical device ce marking process will change when europe s new medical device regulation mdr 2017 745 comes into force in may 2021. 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. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives.