Faculty: Charles Paul | Code: MD2966
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:
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.
Why You Should 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:
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.
Areas Covered in the Session :
Who Should Attend:
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.