Ce Mark Medical Device
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Ce mark medical device. Meeting the eu medical device regulations. The directives outline the safety and performance requirements for medical devices in the european union eu. 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. 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. 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 ce mark is recognized worldwide as a symbol of quality. Ce marking routes of class iia medical devices.
The directives outline the safety and performance requirements for medical devices in the european union eu. The ce mark is a legal requirement to place a device on the market in the eu. 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. Here we can include medical devices such as long term corrective contact lenses surgical lasers defibrillators and others.
Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. Ce medical is an international organization who is specialized in ce marking for medical device products. Class iib medical devices. The medical device regulation eu 2017 745 is a set of requirements and processes for you as responsible party.
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. The ce mark is a legal requirement to place a device on the market in the eu. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. Fundamental as well as up to date information on ce marking and ce marking approval process in full depth.
Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.
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