![\"Representante](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/1920x500_banner_Representante_Europeu_EN-scaled.webp\")
<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>How does CE Marking work?<\/h2>\n
CE Marking<\/strong> contributes to the free circulation of products in the European Union<\/a> market (EU). Simultaneously, guarantees to the authorities and consumers that the products respect the essentials security and health protection requirements.<\/p>\n
In fact, the CE Marking<\/strong> 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.<\/p>\n
To the manufacturers, the CE Marking<\/strong> in their products, is a quality and conformity guarantee to the European Union\u2019s legal requirements, and the possibility of its entrance in the European market.<\/p>\n
To the company, the CE Marking<\/strong> affixation represents the necessary passport for the circulation of its products in the European market.<\/p>\n
The product\u2019s commercialization for a stablished manufacturer out of the European Union (EU) in the European area, covered by the \u201cMedical Devices\u201d and \u201cIn Vitro Medical Devices\u201d Directives, obliges the existence of a Legal or Mandatory Representative of the Manufacturer in Europe.<\/p>\n
What we do?<\/h2>\n
Passarini Regulatory Affairs<\/strong> offers the best prices in the market besides the facility of sending the Technical File in Portuguese.<\/p>\n<\/div>
- <\/i><\/span>\n
Monitoring of the CE Marking process in the company\u2019s products<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nPreliminary Analysis of the target market in the European Union (EU)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nMonitoring of the network implementation of the Product\u2019s Import and Distribution in the European Union (EU)<\/p>\n<\/div><\/li>
- <\/i><\/span>
Your Content Goes Here<\/div><\/li>- <\/i><\/span>
\nContact the Official Entities in the European Union (EU) in the name of the manufacturer<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nEnsure and Declare that the product satisfies the Directives\u2019 requirements<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nIssue the Declaration of Conformity<\/p>\n<\/div><\/li>
- <\/i><\/span>
\n\n\n\n\n\nPlacement of the CE Marking on products<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/li>
- <\/i><\/span>
\nMaintenance of the whole Manufacturer Technical Documentation at disposal of the National Supervisory Bodies<\/p>\n
<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nRequest to the Notified Body the CE Exam-Type<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nRequest to the Notified Body the Conformity Certification<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nRegister the Product in the Relevant National Authorities<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nInform about the Alterations\/Standards revisions \/ Regulations \/ Directives \/ Legislations in the company\u2019s products area<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nSupport 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)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nRepresent your company in front of the CE<\/p>\n<\/div><\/li><\/ul>
<\/div><\/div><\/div>Simplify your access to the European market with Passarini Regulatory Affairs, we can be your European Representative.<\/p>\n
Take the first step towards CE Marking and conquer Europe with safety and efficiency. Contact us so we can present our services, click here!<\/a><\/strong><\/p>\n<\/div>
<\/div><\/div><\/div> - <\/i><\/span>
- <\/i><\/span>