Ce Mark Medical Device Labeling Requirements

Prepare a declaration of conformity doc which states that your device complies with the appropriate directive.

Ce mark medical device labeling requirements.

The ce mark is a legal requirement to place a device on the market in the eu. There are two major areas of confusion about the translation requirements when ce marking a product for export to the eu states. There are 4 classes class i class iia class iib and class iii. They usually constitute low to medium risk.

Obtain ce marking and iso 13485 certificates from your notified body. Ce mark locations include ce mark. Medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.

The full list of these product categories is below. Ce marking routes of class i medical devices. Eu foreign language labeling requirements. The directives outline the safety and performance requirements for medical devices in the european union eu.

Medical devices covered by the directives must bear the ce mark. Class iia medical devices. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. European union ce marking the mark must be accompanied by the id of the notified body when conformity assessment procedures are required.

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. 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 retail sales packaging. The full list of these.

This makes the ce marking recognizable. 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. 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. It shows that the device is fit for its intended purpose stated and meets.

A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. Patients should use them for a short term period any less than 30 days. The device or its sterile package.