Product expertise

cel  The purpose of the expertise: The aim of the report is to determine whether the product meets the definition of a medical device.

dla kogo  Expertise is designed for customers who:

  • intend to manufacture or import medical devices, including the import and sale of products under its own brand (Own Brand Labelling)
  • think about the change of the intended use of the product into the medical device,
  • are not sure whether their product is a medical device (eg. borderline products)
  • seek justification and confirmation of the product qualification.

zakres  The scope of expertise includes:

  • assessing the product in terms of the intended use,
  • determining whether a product falls within the definition of a medical device (8% VAT) and / or if can be classified as a medical device,
  • determining the conditions which the product must meet as a medical device,
  • classification of the product if the product falls under the medical Directive or if not, an indication of a proper Directive,
  • indicating the conformity assessment path for the product,
  • cost estimation of the whole procedure for the conformity assessment of the product from idea to the CE marked product.

wyniki  The result of the expertise is the report.

  • The report contains a full expertise with reference documents (standards, directives, regulations, interpretations).

Required information: Expertise can be made on the basis of the information available on the website or in the product documentation submitted by the manufacturer.

Mydlarska 47
04-690 Warsaw

phone: + 48 22 300 54 31
mobile:+48 508 354 544
mobile: +48 791 480 270