EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Direct

This one-and-a-half-day workshop is based on the highly-regarded and consistently sold out EU workshop at RAPS Regulatory Convergence. Offered for the first time in Europe, the workshop will examine the current directives, and focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This is a can’t miss opportunity to learn from experienced regulatory affairs professionals who are closely engaged with the new emerging EU regulatory requirements. They will share important insights, unique perspectives and address the challenges of the new regulations. There will be two general sessions relevant to all device/IVD manufacturers supplemented with two comprehensive tracks that delve deeper into the specifics of the new MDR and IVDR. The tracks will dig into new classification, conformity assessment, safety and performance, clinical/performance evaluation, technical documentation and postmarket requirements.

By the end of the workshop, you will be aware of the key changes introduced by the new regulations. You also will receive expert interpretation of new expectations and be prepared to develop transition plans to navigate market access (CE Marking) expectations for both new and legacy devices being placed in Europe. If you are working in medical device/IVD regulatory affairs and quality assurance, this workshop will be invaluable.

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Thank you to our sponsors, Medidee and TÜV SÜD Product Service GmbH