Let's prove it.

Regulatory Affairs

Vizera helps you make the right decisions on how to register your product in the EU

Each category brings different opportunities for your product:

  • Medical devices
  • Food supplements with health claim and/or as a novel food
  • Foods for special medical purposes

Success can only be ensured as a result of well-thought-out procedures which are supported with carefully prepared documentation.

  • Classification of the medical device
  • Preparation of supporting documentation to justify the classification
  • Preparation of clinical evaluation report for medical devices for all classes
  • Preparation and compilation of technical documentation
  • Helping in Notified Body selection
  • Offering support during the evaluation procedure at Notified Body
  • Preparation of pre-clinical and clinical scientific data report to justify the product efficacy and safety
  • Preparation and compilation of product documentation for health claim application
  • Preparation and compilation of product documentation for novel food application
  • Offering support during the EFSA evaluation procedure
  • Compilation of documentation for health authorities
  • Submission of relevant documentation for food supplements and food for special medical purposes
  • Communication with health authorities