CE Marking in the EU – Latest Regulations

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA).

CE marking is required for many products. CE marks:

Show that the manufacturer has checked that their products meet EU safety, health or environmental requirements
Are an indicator of a product’s compliance with EU legislation
Allow the free movement of products within the European market
By placing the CE mark on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements necessary to achieve CE marking status. With that mark, the manufacturer is ensuring validity for that product to be sold throughout the EEA.

CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.

If you manufacture products for the EEA it is imperative that you know and understand the regulations that govern the CE marking process particularly in light of the new EU medical device regulation. Manufacturers, distributors, and importers all have roles to play and have responsibilities concerning CE marking.

If you are a manufacturer it is your responsibility to:

Carry out the conformity assessment

• Set up the technical file
• Issue the EC Declaration of Conformity (DoC)
• Place CE marking on a product

If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.

If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.

This webinar will begin with an understanding of the new EU Medical Device Regulation and will walk through the CE marking process explaining all relevant aspects of it to include acquiring and displaying the CE mark.

• The importance of technology transfer
• Understanding the new EU MDR as it relates to the CE Mark
• What products require CE marking?
• Acquiring and placing the CE mark – the conformity assessment
• What are the CE marking image rules?
• CE Marking documentation
• What is the Declaration of Conformity?
• Explain the CE marking enforcement process

• Quality Departments
• Regulatory Departments
• Compliance Departments
• Research and Development Departments
• Audit Personnel
• Risk Managers
• Engineering Departments
• Vice-Presidents, Directors, and Managers of Medical Device Design Functions
• Medical Device Marketing Personnel
• Members of American Society for Quality
• Members of Medical Device Manufacturers Association
• Members of European Medical Device Technology
• Members of Gulf Coast Medical Device Manufacturers

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