Jul 15, 2023
To legally sell a device in the E
To legally sell a device in the European Union, it must bear the CE mark, which the maker of medical devices uses to certify that the product satisfies the applicable General Safety and Performance Requirements (GSPR) of the European Medical Device Regulations. You must categorize the device and choose the best method of conformity evaluation for your product to understand which regulations you need to adhere to. Although gaining a CE label for medical products has several advantages, laws might change at any time.
