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Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.
Ce mark medical device. Meeting the eu medical device regulations. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. Ce marking ce mark is recognized worldwide as a symbol of quality. The directives outline the safety and performance requirements for medical devices in the european union eu.
It shows that the device is fit for its intended purpose stated and meets. Here we can include medical devices such as long term corrective contact lenses surgical lasers defibrillators and others. Ce approval mdr medical devices regulation eu 2017 745 ivdr in vitro diagnostic medical devices regulation eu 2017 746 aimdd active implantable medical device directive no. Ce marking ce mark is a mandatory requirement for medical devices to market in the europe.
Medical device category includes medical equipments medical softwares medical surgical disposables etc. The ce mark is a legal requirement to place a device on the market in the eu. Class iib medical devices. There are four possible routes to ce mark your product split into two groups given the product s type i e if it s sterile or not.
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. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. Ce marking routes of class iia medical devices. 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. Fundamental as well as up to date information on ce marking and ce marking approval process in full depth. The medical device regulation eu 2017 745 is a set of requirements and processes for you as responsible party. 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.
The ce mark is a legal requirement to place a device on the market in the eu. We are a team of experts who provide full support to designers manufacturers exporters importers and distributors in order to ensure that they meet all requirements needed for compliance with european medical devices directives. When your medical device is in accordance with this set of requirements the ce mark can be affixed and the medical device can be legally introduced to the european market.
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