Glossary

SAE [MDCG 2020-10/1]

MDCG

Shortcut for Serious Adverse Event


Any adverse event that led to any of the following:
a) death,
b) serious deterioration in the health of the subject, that resulted in any of the following:

  • i. life-threatening illness or injury,
  • ii. permanent impairment of a body structure or a body function,
  • iii. hospitalisation or prolongation of patient hospitalisation,
  • iv. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body
  • function,
  • v. chronic disease,

c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect

 

[Definition of the term according to MDCG 2020-10/1, entspricht auch Begriffsdefinition gemäß (EU) 2017/745 Artikel 2 Nr. 58]