Conformity assessment procedure – CE marking

Medical devices planned to be marketed in the European Economic Area (EEA) for the first time require a CE-mark. The CE-mark reflects that the manufacturer of a medical device declares that the product complies with the essential requirements for medical devices.
The classification of medical devices according to the 93/42/EEC in its four risk-classes e.g. follows the classification rules of Annex IX of the medical device directive. Depending on the medical device classification several registration procedures are applicable.

PROSYSTEM provides an extensive range of services for the registration of your medical device.

  • Identification of product classification
  • Development of a suitable approval strategy (medical device, in-vitro diagnostic, combination product, machines etc.)
  • Identification of applicable (harmonized) standards, guidelines and directives
  • Creation of needed technical documentation for the approval of all medical device classifications
  • Development and implementation of medical device labeling (UDI, electronical Instructions for Use)
  • Procedures for the identification and implementation of requirements resulting from revised standards, guidelines and directives

Technical documentation for the assessment of conformity

Manufacturers of medical devices need to hold the technical documentation for each medical device. Depending on the devices intended use and risk-classification, specific requirements on technical documentation need to be fulfilled. These result from the applicable standards, guidelines and directives.

Technical documentation contains but is not limited to:

  • Administrative information
  • Intended use and description of a medical device
  • Technical data of the medical device
  • Checklist of essential requirements
  • List of applied standards
  • Risk management, usability and clinical evaluation
  • Documented evidence about verification and validation of the implementation of product requirements
  • Instructions for use, accompanying documents and labeling

PROSYSTEM supports you in identifying and implementing the requirements on the content of your technical documentation. PROSYSTEM provides you with experience from its standardization work and superb knowledge in interface topics such as quality management, software development, clinical assessment and clinical trials.