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