Before you can sell a medical device or IVD within Europe, you must obtain CE Marking certification and place a CE Mark (CE Marking) on your product. The CE Marking for medical devices is not a quality mark nor is it intended for consumers. It is a legally binding statement by the manufacturer that their product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), where applicable. If a Notified Body is required, the Notified Body's four-digit number would appear below the CE Marking symbol.
The Medical Devices Directives state that companies must do the following before they can place the CE Marking on a medical device or IVD:
Only after these CE Marking requirements are satisfied are you allowed to place the CE Marking on your medical device.
Emergo Group has assisted hundreds of companies with medical device CE Marking. Our services include:
Emergo Group can develop a compliant quality management system by applying ISO 13485:2012 to ensure you meet the quality system requirements for Europe. Each system is customized for the manufacturer and can not only ensure compliance to the European Directives for Medical Devices (CE Marking), but also to the Canadian Medical Devices Regulations, United States FDA QSR, Australian TGA requirements, and Japanese Pharmaceutical Affairs Law.