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.
The Passarini Regulatory Affairs offers the best prices in the market besides the facility of sending the Technical File in Portuguese.
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Preliminary Analysis of the target market in the European Union (EU)
Monitoring of the network implementation of the Product’s Import and Distribution in the European Union (EU)
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Contact the Official Entities in the European Union (EU) in the name of the manufacturer
Ensure and Declare that the product satisfies the Directives’ requirements
Issue the Declaration of Conformity
Placement of the CE Marking in the products
Maintenance of the whole Manufacturer Technical Documentation at disposal of the National Supervisory Bodies
Request to the Notified Body the CE Exam-Type
Request to the Notified Body the Conformity Certification
Register the Product in the Relevant National Authorities
Inform about the Alterations/Standards revisions/Regulations/Directives/Legislations in the company’s products area
Support the company in other subjects related to the European Union (EU) market, namely in the Trademark Community Register and in the Models Community Register of the products in the European Union (EU). Support the company in the organization of Events in the European Union (EU)
Represent your company in front of the CE