Ce Mark Medical Device Meaning

To facilitate trade throughout the european economic area eea products need to be identified as compliant with regional and national regulations.

Ce mark medical device meaning.

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. How to determine if your product requires a ce mark in the eu if you want to know whether your product is considered a medical device in the eu and if you want to know the definition of a medical device in the eu do read on. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. The directives outline the safety and performance requirements for medical devices in the european union eu.

Is my product a medical device. Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. It shows that the device is fit for its intended purpose stated and meets.

This makes the ce marking recognizable. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. The ce mark is a legal requirement to place a device on the market in the eu. Examples of medical devices with an ancillary medicinal substance include drug eluting stents bone cement containing an antibiotic catheters coated with heparin or an antibiotic agent and condoms coated.

The ce mark is a legal requirement to place a device on the market in the eu. 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. As a legal medical device manufacturer you are responsible for maintaining regulatory compliance and securing ce marking for your product regardless of whether you outsource any. These products fall under the medical devices legislation and must be ce marked.

The answer to what may appear to be a simple question is in some cases quite complex.