Ce Mark Medical Device Labeling Requirements

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 medical device labeling requirements. This makes the ce marking recognizable. Prepare a declaration of conformity doc which states that your device complies with the appropriate directive. 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. The full list of these.

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

Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. The full list of these product categories is below. The retail sales packaging. 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. Each medical device is classified into the risks involved. Medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc. Ce marking routes of class i medical devices.

They usually constitute low to medium risk. The ce mark is a legal requirement to place a device on the market in the eu. Eu foreign language labeling requirements. The device or its sterile package.

There are 4 classes class i class iia class iib and class iii. Patients should use them for a short term period any less than 30 days. The directives outline the safety and performance requirements for medical devices in the european union eu. Ce marking applies to products ranging from electrical equipment to toys and from civil explosives to medical devices.

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. Medical devices covered by the directives must bear the ce mark.