The EU MDR & IVDR regulations have been published and the timeline is set for manufacturers that want to continue to sell their devices in Europe. The EU MDR & IVDR Conference (hosted by the producers of the annual UDI Conference) will bring together leading European experts to provide critical information and guidance to help you prepare to meet the timelines.
More importantly, you will be exposed to a philosophical and strategic approach to efficiently managing your devices from a global vantage point, rather than just an immediate compliance effort. It is our intention to raise the critical awareness that medical device manufacturers need to learn to manage devices to stay in regulatory and commercial compliance in the ever-expanding global UDI-related regulatory and commercial framework.
Features of the Conference will include:
- The impact of MDR & IVDR compliance and adoption for medical device manufacturers
- Dissection of the technical components of the regulations (re-certification, reclassification, UDI) and resources to provide ongoing support
- The importance of value beyond compliance – creating an overarching approach
- The matrix concept of managing devices in the rapidly expanding global regulatory landscape
- MDR & IVDR related standards development and ongoing harmonization efforts
- The similarities and differences between the EU and US UDI Regulations
- Discussion of the new processes and players that must be internalized
- Defining Notified Bodies and the European Commission responsibilities and impacts