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

We offer:

For medical devices:

  • 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

For food supplements:

  • 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

For foods for special medical purposes:

  • Compilation of documentation for health authorities
  • Submission of relevant documentation for food supplements and food for special medical purposes
  • Communication with health authorities

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

Clinical trials

Clinical Trials

Vizera has a wealth of experience in clinical trials of medical devices and nutraceuticals and provides support with the EFSA claim submission. We also perform clinical trials for pharmaceuticals phase III and IV. We are highly skilled in several therapeutic areas, some of which include diabetes, prediabetes, wounds, gastroenterology, cognitive functions, paediatric health, the immune and cardiovascular systems, urology and gynecology.

Research and development

Medical Device Regulatory Services

Before a medical device is introduced  to the market it must obtain the CE mark. Vizera  is experienced in clinical evaluation report preparation as well as complete technical documentation. Vizera also helps you to make the right decisions on how to register your product in the EU in order to avoid incurring additional time and financial costs.

Business Enquiry

If you are interested in finding out more about regulatory affairs, you are kindly invited to complete the enquiry form below or send us an e-mail. All information you provide will be kept strictly confidential.

1.First name *
2.Surname *
3.E-mail *
4.Telephone *
5.Company name *
6.What type is your product?
7.What is the type of service?
8.When would you like to start with the project?
9.Is there anything else you would like to share with us?