Medical Devices intended to be legaly marketed in the European Union require a CE-mark. The CE-mark is declaration of the medical device manufacturer that his product conforms to the essential requirements in Annex I of the European Medical Device Directive 93/42/EEC.

In the European Union medical devices are categorized into 4 classes:

class I - class IIa - class IIb - class III

the classification of the medical device is conducted according the classification rules of Annex IX of the Medical Device Directive.

Dependend on the classification of the medical device several approval strategies are applicable.

PROSYSTEM provides you comprehensive consulting services for the CE-marking of your medical device:

• Product classification
• Development of an appropriate approval strategy
• Identification of aplicable harmonized standards
• Implementation of a quality management system according to ISO 13485
• Compilation of the required technical files
• Compilation of Design Dossiers for class III products 

Please contact us for further details or a non-binding quotation.