Medical devices

Act No 123/2000 Coll., on Medical Devices and on Amendments to Some Related Acts, as amendedThis area is also governed by Act No 22/1997 Coll., on Technical Requirements for Products and Amendments to Some Related Acts, as amended

Implementing regulations:
  • Government Regulation No 453/2004 Coll., on technical requirements for in vitro diagnostic medical devices 
  • Government Regulation No 336/2004 Coll., on technical requirements for medical devices, amending Government Regulation No 251/2003 Coll., amending some government regulations issued as implementing for Act No 22/1997 Coll., on Technical Requirements for Products and Amendments to Some Related Acts, as amended 
  • Government Regulation No 154/2004 Coll., on technical requirements for active implantable medical devices, amending Government Regulation No 251/2003 Coll., amending some government regulations issued as implementing for Act No 22/1997 Coll., on Technical Requirements for Products and Amendments to Some Related Acts
  • Government Regulation No 342/2000 Coll., laying down medical devices which may jeopardize the health of man
  • Decree No 316/2000 Coll., on particulars of the final report on a clinical evaluation of a medical device, as amended
  • Decree No 356/2001 Coll., on granting exceptions from technical requirements on medical devices for their usage at providing health care and on scope of released data on their authorization, as amended
  • Decree No 501/2000 Coll., on the forms and methods of reporting adverse incidents of medical devices, their filing, investigation, and evaluation, documentation and its storage and follow-up intended to prevent the occurrence of adverse incidents, in particular their recurrence (Decree on adverse incidents of medical devices), as amended
  • Decree No 11/2005 Coll., on types of medical devices with increased risk for users or other parties and on the monitoring of these devices after their placement onto the market, as amended