Ce Mark Medical Device Search

Mark on a medical device once it has passed a conformity assessment.
Ce mark medical device search. Ce mark certification must be done by an eu based notified body. You should not place a ce mark on your medical device if it is. The directives outline the safety and performance requirements for medical devices in the european union 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.
It is a criminal offence to affix a ce mark to a product that is not compliant or offer it for sale. Medicines under evaluation. 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.
The ukca certification does not apply. 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. Departments worldwide how government works get involved consultations statistics.
These products fall under the medical devices legislation and must be ce marked. 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. What we publish and when. Where a device has been assessed by a uk approved body the uk ni mark will accompany but not replace the ce mark.
Products carrying both the ce mark and uk ni mark cannot be placed on the eu market. 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.