Attaining Your CE Mark for Your Medical Device in the EU

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.

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

Learning 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

Areas Covered in the Webinar:

• 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