CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
CA - Submission for authorisation mandatory for
MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP
CA - Submission required to
National CA
CE-marked MD used within label are exempted from any notification obligation to CA
Yes
Applicable national legal framework/ Reference
Section 14 of Act No 268/2014 Coll. on Medical Devices
Submission to CA and EC to be performed in the following order
EC first