CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
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
MD Class III
Other high-risk devices (Class IIa or IIb implantable and long-term invasive MDs)
CA - Registration/ notification without approval required for
Observational MD investigations
MD CE-marked, use within label
MD CE-marked, use within label + IMP
MD Class I
MD Class IIa
MD Class IIb
Applicable national legal framework/ Reference
Section 14.8 Legislative Decree/ Decreto lgs. n. 46/97, as amended by Legislative Decree n. 37/2010
Section 2.2 Legislative Decree/ Decreto lgs. n. 46/97, as amended by Legislative Decree n. 37/2010
