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

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