Ce Mark Medical Device Meaning

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

Ce mark medical device meaning.

The directives outline the safety and performance requirements for medical devices in the european union eu. Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. 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. 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.

A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. The directives outline the safety and performance requirements for medical devices in the european union eu. 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. It shows that the device is fit for its intended purpose stated and meets.

The ce mark is a legal requirement to place a device on the market in the eu. These products fall under the medical devices legislation and must be ce marked. 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 is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.

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. Is my product a medical device. The author answers the question of what does the ce mark means what its purpose is related to medical devices and regulatory requirements if applicable. To facilitate trade throughout the european economic area eea products need to be identified as compliant with regional and national regulations.

A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives.