CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
National Ethics Committee
Other
Regulatory and ethics bodies involved in approval process: Competent Authority- Infarmed; National Ethics committee (CEIC); Recruiting sites: Administration Board and Local Ethical Committee

CA - Submission for authorisation mandatory for

Active Implantable Medical Devices (AIMD)
MD without label
MD Class IIa
MD Class IIb
MD Class III
CA - Submission for authorisation mandatory for: Class IIa, IIb used for long periods of time; Class III; Invasive/ Active Implantable; Without CE label

CA - Registration/ notification without approval required for

Performance evaluations of in-vitro diagnostic MDs
MD Class I
MD Class IIa
MD Class IIb
CA - Registration/ notification without approval required for: Class I, IIa and IIb (use for short periods of time); In Vitro Diagnostic

CA - Submission required to

National CA
Other
Infarmed, CEIC (national ethical committee), recruiting sites: administration boards and local ethical committees

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 33 Law 21/2014 (pt)
Art 12 DL 145/2009 (pt))

Additional Information

Submission to CA and EC to be performed in the following order: In parallel

Submission to CA and EC to be performed in the following order

In parallel
Sequentially (in any order)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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