Ce Mark Medical Device Search

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Ce mark medical device search.

Where a device has been assessed by a uk approved body the uk ni mark will accompany but not replace the ce mark. Medicines under evaluation. Examples of medical devices with an ancillary medicinal substance. Hello i m wondering if there s a centralized publicly available list database of medical devices that have received the ce mark in europe thanks for helping.

Products carrying both the ce mark and uk ni mark cannot be placed on the eu market. The ce mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant eu legislation and the product may be sold anywhere in 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. You should not place a ce mark on your medical device if it is.

The ce mark is a legal requirement to place a device on the market in the eu. Ce mark certification must be done by an eu based notified body. The ukca certification does not apply. These products fall under the medical devices legislation and must be ce marked.

The directives outline the safety and performance requirements for medical devices in the european union eu. Mark on a medical device once it has passed a conformity assessment. What we publish and when. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.

The adoption in. Ce marking routes of class i medical devices class iia medical devices medical devices of class iia could be such as surgical gloves hearing aids diagnostic ultrasound machines etc.