Achieving your CE Mark in the EU for your Medical Devices


Charles H. Paul is Keynote Speaker at Compliance key Inc. He is President of C. H. Paul Consulting, Inc. - a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of relate........

Overview

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
  • Is 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.

Why should you attend this webinar?

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 can Benefit:

Anyone producing medical devices for the EU. Directors, managers, associates - scientists, engineers, marketing personnel, quality assurance, regulatory compliance.



Webinar Id: LSHCCP413

Training Options:

Duration: 60 mins

 View anytime

 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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