The sessions will provide an overview of the “NEW CE Marking” process, according to the Medical Device Regulation. The Brexit (UK requirements) and Swixit (Switzerland requirements) outcome for medical devices will be discussed. It goes into details on specific critical subjects for the manufacturer and outlines the changes a manufacturer must consider.
The concepts are set and manufacturers who want to enter the EU Market and/or do not want to risk the CE marking for their products must evaluate the changes and additions NOW in order to prepare for a timely implementation. The transition period is short and Europe does not allow “Grandfathering”
It is important to know the new specific requirements for your products and the timelines available to make sure that your products and your company are ready for the “NEW CE Marking”.
Who will benefit?
Medical device manufacturers who market or plan to market their products in Europe.
Medical device professionals - CEO, Lawyers, Regulatory and Compliance experts, risk management – since it is crucial to fully understand the EU requirements.