CE Marking 93/42/EEC Course Outline
and the new MDR
2 day course
Every medical device you place on the market in the EU must have a CE mark – it’s a mandatory legal requirement. You probably know that already, but are you sure you are fully up to date with all the regulatory requirements and standards involved, especially in the current changing regulatory environment? Would you benefit from a refresher on CE marking coupled with a deep dive into the new Medical Device Regulation to understand the impact this could have on both new and already marketed Medical Devices?
This course provides a working understanding of the major features of the Medical Devices Directive and comparisons to the new Medical Device Regulation, including terminology, product classification, conformity assessment routes, and Technical Files, including the Essential Requirements and will look at the significant changes on the horizon. As well as guiding you through the Medical Device Directive, it brings you up to scratch with all the other relevant legislation you need to understand, including the new Medical Device Regulations and the implementation timelines.