Development of the documentation for the CE marking and registration

Documentation development and consultancy in relation to CE marking for medical devices, as well as to ISO 13485 Quality Management System – for medical devices, and ISO 22716 Cosmetics Good Manufacturing Practice. We are consulting on issues related to execution and registration of the “Novel food Product” status within the territory of the European Union.

We offer development of the high-quality documentation and our advice, based on years of experience and understanding of international standards and requirements for product documentation execution in the European Union (EU). This kind of services will allow you to save time and human resources, and you will be able to promote products in the EU market more rapidly and dynamically.

Introduction of medical devices into the European Union

For the medical devices to be introduced into the market, the EC declaration of conformity should be executed and marked with CE conformity marking. Medical device can be introduced into the market only if all essential requirements stated by special rules have been down.

Why CE marking is required for medical devices?

Medical devices require the CE marking before they can be sold within the territory of the European Economic Area, which includes all EU Member States, Iceland, Liechtenstein and Norway. The CE marking certifies that the medical device has been evaluated and meets the EU safety and health requirements. Used for medical devices, which are manufactured in the EU and outside the EU, and which are then sold in the EU. The CE marking may be used only for those medical devices, whose specifications have been developed at EU level. Large amount of technical documentation is required in order to assign the CE marking to the medical device, which certifies that it meets all EU requirements. The manufacturer must declare that the product complies with all the requirements. When the medical products have CE marking, distributors and importers may require you to present all documents justifying the use of CE marking.

What is ISO 13485 Quality Management System – for medical devices?

International Standard ISO 13485 specifies requirements for the Quality Management System that can be used for the development of medical devices, production, assembly, services, design, provision of development and related services. All distributed medical devices in the EU market should be manufactured in accordance with EU directives in order to ensure the safety and the required quality of medical devices.

What is ISO 22716 Cosmetics Good Manufacturing Practices, GMP?

In order to ensure the safety and high quality of cosmetics, Cosmetics Regulation states all the requirements of the product distribution. All distributed cosmetic products in the EU market should be produced in accordance with the requirements of the Cosmetics Good Manufacturing Practice. Requirements are relating to the chain participants, even if they are not attributed to any EU Member State. Requirements are set both for the component manufacturers and product manufacturers as well as for the importers and exporters … Find out more information by contacting the experts of the company “Infarma”.

What is Novel food?

“Novel Food Product” is defined as any food, which was not used on a significant scale for human consumption prior to May 15, 1997 in the European Union, and can be classified in one of the following categories:

  • Food with a new or intentionally modified primary molecular structure, if the mentioned structure was not used in the EU as the food or food ingredient before the stated deadline.
  • Food, consisting of, isolated or manufactured from microorganisms, fungi or algae.
  • Food, consisting of, isolated or manufactured from materials of mineral origin.
  • Food, consisting of, isolated or manufactured from plants or their ingredients, except for cases, when this food has a history of safe food consumption in the EU, and consisting of, isolated or manufactured from the plant or the same species, obtained by traditional propagating practice, which was used for food manufacturing in the EU before the stated deadline, or by non-traditional propagating practice, which was not used for food manufacturing in the EU before the stated deadline, if the stated practice does not provoke significant changes in food composition or structure, which affects its nutritional value, metabolism or level of undesirable substances.

 

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Use the opportunity to get free advice in person. We will provide information about the specifics of the pharmaceutical industry, as well as about our services and achieved results. We adapt the service to your requirements as much as possible. Learn more about the service!


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