Ce Mark Medical Device

The directives outline the safety and performance requirements for medical devices in the european union eu. Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. 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.

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The directives outline the safety and performance requirements for medical devices in the european union eu.

Ce mark medical device.

The medical device regulation eu 2017 745 is a set of requirements and processes for you as responsible party. 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. Meeting the eu medical device regulations. Fundamental as well as up to date information on ce marking and ce marking approval process in full depth.

Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives. A ce mark is a logo that is placed on medical devices to show they conform to the requirements in the 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. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device.

Class iib medical devices. 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. It shows that the device is fit for its intended purpose stated and meets. 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.

Ce marking routes of class iia medical devices. Ce marking ce mark is a mandatory requirement for medical devices to market in the europe. The ce mark is a legal requirement to place a device on the market in the eu. Ce marking ce mark is recognized worldwide as a symbol of quality.

Here we can include medical devices such as long term corrective contact lenses surgical lasers defibrillators and others. Medical device category includes medical equipments medical softwares medical surgical disposables etc. Ce medical is an international organization who is specialized in ce marking for medical device products. Ce marking is the medical device manufacturer s claim that a product meets the essential requirements of all relevant european medical device directives.

These products fall under the medical devices legislation and must be ce marked. 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. The ce mark is a legal requirement to place a device on the market in the eu.

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