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.

Course Objectives:

At the completion of this webinar, participants will be able to:

• Explain how the new EU MDR relates to the CE Mark
• State the products that require CE marking
• Explain how the CE mark is acquired and placed
• Explain the CE marking image rules
• List and describe the CE Marking documentation that is required
• Define the term Declaration of Conformity
• Explain the CE marking enforcement process

Why Should You Attend:

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.

Course Outline:

• The new EU MDR and the CE Mark
• Products requiring CE marking
• Acquiring and placing the CE mark
• The CE marking image rules
• CE Marking documentation
• Declaration of Conformity?
• CE marking enforcement process

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all device manufacturers who wish to sell product in the European Community. The employees who will benefit include:

• Top management
• Regulatory management
• Quality Management
• Sales and Marketing Management
• Quality Engineers
• Other personnel involved in development and implementation of the QMS
• Senior management responsible for success in the European marketplace.
• QA, RA and other compliance managers and personnel wanting to learn how to comply with European regulatory requirements for medical devices.
• R&D managers and engineers.
• Manufacturing managers.
• Marketing and business development managers.
• Legal counsel wanting a non-legal explanation of European requirements for medical devices.
• Anyone wanting to really understand the fundamentals of the European New Approach and what must be covered