How does CE Marking work?
CE Marking contributes to the free circulation of products in the European Union market (EU). Simultaneously, guarantees to the authorities and consumers that the products respect the essentials security and health protection requirements.
In fact, the CE Marking symbolizes the conformity with all the obligations that is incubated to the manufacturers about their products, in force of the Common Directives that foresees, being this mandatory and of exclusive use.
To the manufacturers, the CE Marking in their products, is a quality and conformity guarantee to the European Union’s legal requirements, and the possibility of its entrance in the European market.
To the company, the CE Marking affixation represents the necessary passport for the circulation of its products in the European market.
The product’s commercialization for a stablished manufacturer out of the European Union (EU) in the European area, covered by the “Medical Devices” and “In Vitro Medical Devices” Directives, obliges the existence of a Legal or Mandatory Representative of the Manufacturer in Europe.
What we do?
Passarini Regulatory Affairs offers the best prices in the market besides the facility of sending the Technical File in Portuguese.
Simplify your access to the European market with Passarini Regulatory Affairs, we can be your European Representative.
Take the first step towards CE Marking and conquer Europe with safety and efficiency. Contact us so we can present our services, click here!
