CE marking

CE marking is a legal requirement for medical devices intended for sale in Europe. The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.

There are three European CE marking directives that specifically apply to medical devices manufacturers:

1.)The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
2.)The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
3.)The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.

 The marking is mandatory for products sold not only within the 27 countries of the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) but more generally within all countries of the European Economic Area (EEA) which also includes the 4 countries of the European Free Trade Area (EFTA: Iceland, Liechtenstein, Norway, including Switzerland although it is not a member of the EEA), as well as within Turkey (as a result of the non-agricultural European Union-Turkey Customs Union).