Significant changes ahead for medical device and in vitro diagnostic manufacturer as well as for Notified Bodies. The new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) will impact all device manufactures. In addition changes to clinical evidence requirements based on the new MEDDEV 2.7/1 Rev. 4 are already in effect. Medical device and IVD manufacturers are going to be confronted with major changes in the EU’s decades-old regulatory framework .
1st attendee 540,00+VAT, 1st attendee mdc clients EUR 490,00+VAT, further attendees of the same organization EUR 490,00+VAT.