EU Medical Device & InVitro Diagnostic CE Marking Workshop
Time & Location
About the Event
To put Medical Devices or IVDs on the market in Europe they must have a CE mark. The MDR and IVD regulations are in transition and companies need to understand and prepare for these significant changes. Attendees of this one-day event will gain an understanding of:
- The new IVD and Medical Device Regulations (EU 2017/745 & 746), device classification and key time lines
- Significant differences between the current directive and the new regulations
- The role and status of Notified Bodies and competent authorities
- The 10 steps to gaining and maintaining your CE mark
- What is a CE mark conformity assessment?
- Outline of the Technical Documentation and Declaration of Conformity requirements
- Outline of the Quality System requirements
- Outline of the Clinical evidence and Performance requirements
- Role of the Person Responsible for Regulatory Compliance
- Outline of Post Market Surveillance requirements
- Understanding of research, health institution exemption and putting a device on the market
- Interact with fellow practitioners and presenter during the Q&A
The European Union’s Regulation on Medical Devices 2017/745 (MDR) and IVD medical devices 2017/746 (IVDR) came into force on 25 May 2017 and is currently in implementation. It will replace Directive 93/42/EEC on medical devices and 98/79/EC on IVD medical devices. The medical device regulations come into affect in May 2020 and the IVD regulations in in May 2022. In both cases device manufacturers do not have a lot of time left to prepare and be ready for the transition.
This seminar will provide you insights into the key regulatory requirements and changes and help you to prepare your organisation and your devices to obtain or maintain compliance.