Major Changes and Timing for Compliance!
Understanding the new regulations of the European market is a challenge for every medical device manufacturer, and especially for those outside the EU. Not only is the transition from the directive to the regulation of Medical Devices and Invitro Diagnostic Devices, but Brexit has also been added with the UKCA marking.
Knowing how the transition is, the new requirements, the dates and the new grace periods for the exceptions is a key point for any company that wants to enter the market of the European Union and the United Kingdom. As it is also for companies that are within this market but need to continue marketing their products there, and need to meet these requirements.
Through this webinar we intend to show which are the major changes in the directive to the regulation of medical devices and in vitro diagnostic, focusing on the new requirements of the Clinical Evaluation Report (MDR) and Performance Evaluation (IVDR). We also want to leave a schedule of dates that the different classifications of medical devices must meet in order to be in the European market (EU & UK).