Project Description

CE Marking services: What is CE Certification?

CE Marking has contributed to the free circulation of products in the European Union (EU) market. At the same time, it guarantees authorities and consumers that the products comply with the essential requirements in terms of safety and health protection.

In fact, the CE Marking symbolizes compliance with all the obligations that manufacturers have in relation to their products, under the community directives that provide for it, which is mandatory and for exclusive use.

For manufacturers, the CE Marking on their products is a guarantee of quality and compliance with the legal requirements of the European Union, and the possibility of their entry into the European market. For the company, the affixing of the CE Marking represents the necessary passport for the circulation of its products in the European Market.

The commercialization by a manufacturer established outside the European Union (EU), of its products in the European Area, covered by the “Medical Devices” and “In Vitro Medical Devices” Directives, requires the existence of a Legal Representative or Mandate of the Manufacturer in Europe.

Is CE Certification mandatory?

CE Marking is mandatory for a wide range of consumer products marketed within the European Union (EU). CE Marking shows the product meets statutory requirements on, for instance, fire safety.

Construction products that fall under the European Harmonised Standards also need to have a Declaration of Performance (DoP), which contains product and address details. Manufacturers, importers and distributors of construction products must supply this DoP with the product.

Do I need to pay any fees for CE Marking?

If you as a manufacturer carry out the conformity assessment yourself, you won’t have to pay any fees. However, if you opt to use the services of a notified body, or if the EU specifications applicable to your product require the independent assessment by a notified body, then you must pay the notified body for the service they provide. The cost depends on which certification procedure that applies to your product and the complexity of the product etc.

How to obtain CE Marking services?

Passarini Regulatory Affairs is able to prepare your Technical File independently of the risk and with specialists with extensive experience in clinical validations, risk management, usability processes and all MED.DEV required in the European Community.

In addition, we provide the necessary tests, train those involved in the company, assist in the development of European representation etc. We also assist in the selection of qualified, agile and cost-effective certifiers according to your project.

Passarini Regulatory Affairs offers the best prices ​​in the market. And helps you the whole process:

  • Monitoring the CE Marking process on the company’s products
  • Preliminary Analysis of Target Markets in the European Union (EU)
  • Monitoring the implementation of the Import and Distribution network of products in the European Union (EU)
  • Contacting Official Entities in the European Union (EU) on behalf of the Manufacturer
  • Ensure and Declare that the Product meets the requirements of the Directives
  • Issue the Declaration of Conformity
  • Placement of CE Marking on products
  • Maintenance of all Manufacturer’s Technical Documentation available to National Inspection Entities
  • Ask the Notified Body for the EC-Type Examination
  • Ask the Notified Body for the Certification of Conformity
  • Register the Product with the Competent National Entities
  • Inform about Changes / Revisions of Standards / Regulations / Directives / Legislation within the scope of the company’s products
  • Support the company in other matters related to the European Union (EU) market, namely in the Community Trademark Register and the Community Register of Product Models in the European Union (EU). Support the company in organizing Events in the European Union (EU).
  • Represent your company before the EC.

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