DeviCE Sistemas

CE Marking

We are a consultancy specialised in CE Marking of Medical Devices, Medical Devices for In Vitro Diagnostics and Machine.

About deviCE sistemas

At deviCE sistemas we are a consultancy firm that helps your company to obtain CE Marking for your product.

We provide a very close and personalised service, adapting to the needs of our clients.

We can solve all the needs related to the CE Marking and assurance of your product, with very specific and individualised services for your needs.

In deviCE Sistemas we help you to obtain the CE Marking of your product.

At deviCE Sistemas we help your company to obtain the CE Marking for your product.

What is CE marking?

The CE Marking is the mark obtained after the process by which the manufacturer of a product indicates that it complies with all the applicable requirements established in the European Community harmonisation legislation.

The CE Marking guarantees the safety and quality of a product so that it can be marketed in the European Union and is the passport for products, guaranteeing their free circulation in the European Economic Area (EEA).

Why is CE marking important?

In addition to being a legal requirement, in order to be marketed, they must meet the technical criteria set out in the applicable EU harmonisation legislation, including the placement of the logo on the product or accompanying documentation, regardless of where the product is manufactured.
We are living in a time of major change in the regulation of medical devices. This change brings with it numerous changes in the way companies deal with the medical device lifecycle and, in many cases, an increase in their obligations.

The entry into force in 2017 and the application from 26 May 2021 of Regulation (EU) 745/2017 on medical devices and from 26 May 2022 of Regulation (EU) 746/2017 on in vitro diagnostic medical devices, materialises the changes and, therefore, the adaptation needs of the medical device manufacturing, importing or distributing company, among others.

Likewise, the European Machine legislation is undergoing a major revision and modification as it is going from a European directive (Directive 2006/42/EC) to a European Regulation, expected by the end of 2021. This major change will drag on to other machine-related legislation such as the Adequacy of Machinery and harmonised reference standards.

At deviCE Sistemas we help your company to obtain the CE Marking for your product.