Declaration of conformity

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Seller_QI5zXS2dhDKX2

Declaration of conformity

Hi all,

Our product comes in contact with the human body. It is a borderline product between the category of cosmetics and the category of medical/surgical devices. Amazon has asked us to provide the declaration of conformity. We are manufacturing this product ourselves. We are finding it difficult to determine which directives apply to this product.
Secondly, we are also confused if we should involve some notified body to declare the product as safe or we can do it ourselves? EU law doesn’t make it binding ti get it tested by some notified body.

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Seller_7VbclcPFFRTnc

Without stating the obvious , as a manufacturer, have you checked out the legal requirements of making items sold as medical/surgical devices ?!

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Seller_QI5zXS2dhDKX2

We didn’t check that. Neither they have asked us so far

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