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Medical Devices are characterised by the CE marking, which indicates that they comply with the legislation established by the European Community and which allows their free circulation within the countries of the Union.
Depending on the type of medical device, one of the Directives established in the 1990s applies to it:
Prior to CE marking of the medical device, an assessment for compliance with the Essential Requirements for Quality, Safety and Efficacy of the product must be carried out by a Notified Body.
Each Agency has an identifying number which appears next to the CE marking of the evaluated product.Class I products that are neither sterile nor have a measuring function are exempted from this conformity assessment by an external body. In order to be marketed, it is sufficient that a self-certification is carried out by the legal manufacturer of the product assessing that all regulatory requirements are met.