Ce Mark Medical Device Search

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.

Ce mark medical device search.

It is a criminal offence to affix a ce mark to a product that is not compliant or offer it for sale. The adoption in. The directives outline the safety and performance requirements for medical devices in the european union eu. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.

Examples of medical devices with an ancillary medicinal substance. You should not place a ce mark on your medical device if it is. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. Medicines under evaluation.

The ukca certification does not apply. 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. Departments worldwide how government works get involved consultations statistics.

What we publish and when. Ce mark certification must be done by an eu based notified body. The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. 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.

Where a device has been assessed by a uk approved body the uk ni mark will accompany but not replace the ce mark. 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.