Ce Mark Medical Device Requirements

For a medical device manufacturer or distributor ce marking is the declaration that the product complies with all eu directives or eu regulations that apply to the medical device.

Ce mark medical device requirements.

Ce marking does not implies that the product was made in the european economic area but it states that the product is complying with the requirements of european. The directives outline the safety and performance requirements for medical devices in the european union eu. In order to ensure that conformity assessment under the medical device directive functions effectively from january 1995 manufacturers should be able to know as early as possible in which class their. A medical device classification system is therefore needed in order to channel medical devices into the proper conformity assessment route.

Obtain ce marking and iso 13485 certificates from your notified body. If your medical device is in any other class apart from class i you will have to provide the notified body with proof that your product fulfils the essential requirements of the respective ce directives. Preconditions for ce marking a medical device meets requirements by mdd respectively mdr the first precondition that a manufacturer affixes the ce mark is that the medical device fulfills the essential requirements as laid out in annex i of mdd respectively the general safety and performance requirements as laid out in annex i of mdr. Keep reading to learn more about each class and what steps you will need to pass to ce mark medical devices.

Class i medical devices. 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. The medical device ce marking process will change when europe s new medical device regulation mdr 2017 745 comes into force in may 2021.

Prepare a declaration of conformity doc which states that your device complies with the appropriate directive. 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. This makes the ce marking recognizable. 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. 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.