EU Medical Device & InVitro Diagnostic CE Marking Workshop

SEHTA and Psephos Biomedica are pleased to run their first workshop in the Cambridge area on EU Medical Device & InVitro Diagnostic CE Marking.

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