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 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. Ce mark medical devices labeling requirements. There are 4 classes class i class iia class iib and class iii.

The directives outline the safety and performance requirements for medical devices in the european union eu. Medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc. This makes the ce marking recognizable. Medical devices covered by the directives must bear the ce mark.

Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. Obtain ce marking and iso 13485 certificates from your notified body. The retail sales packaging. European union ce marking the mark must be accompanied by the id of the notified body when conformity assessment procedures are required.

Patients should use them for a short term period any less than 30 days. Each medical device is classified into the risks involved. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. 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. The device or its sterile package. Eu foreign language labeling requirements. The medical device ce marking process will change when europe s new medical device regulation mdr 2017 745 comes into force in may 2021.

Ce mark locations include ce mark. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. The full list of these. Class iia medical devices.

Ce marking routes of class i medical devices. It shows that the device is fit for its intended purpose stated and meets. Ce marking applies to products ranging from electrical equipment to toys and from civil explosives to medical devices.