CE marking

The CE marking certifies that our products comply with European safety, quality and performance standards. This mark guarantees that every container and component manufactured in Triana has been assessed in accordance with the standards required for sale on the European market.

What is CE marking?

Medical devices are characterised by bearing the CE mark, which indicates that they comply with the legislation established by the European Community and allows them to circulate freely within the countries of the Union.

Depending on the type of medical device, one of the Directives established in the 1990s applies:

Active implantable devices, Directive 90/385/EEC (AIMD)
Medical devices, Directive 93/42/EEC (MDD)
In vitro diagnostic medical devices, Directive 98/79/EC (IVDD)

A regulation does not need to be transposed into the legislation of each Member State and, therefore, from the date of application, it is in force in each and every country that makes up the European Union. This should prevent discrepancies depending on the country in which the device is marketed and will therefore benefit patients, given that the most important thing about these products, apart from their proven effectiveness, is that they are safe for users.

Conformity assessment

As a preliminary step to CE marking of the medical device, an assessment must be carried out by a Notified Body to verify compliance with the Essential Requirements for Quality, Safety and Efficacy of the Product.

Each Body has a number that identifies it and appears next to the CE mark on the assessed product.

Class I products that are not sterile and do not have a measuring function are exempt from this conformity assessment by an external body. For marketing purposes, it is sufficient for the legal manufacturer of the product to carry out a self-certification assessing that all regulatory requirements are met.

Evaluación de conformidad previa al marcado CE

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