CATrialAuthorisation object

Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)

Observational MD investigations
MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP

National CA (AEMPS - SGPS)

Yes

Yes

There is an official national registry in Spain:
REec - Registro Español de Estudios Clínicos (Spanish National General Registry of Clinical Studies)
It is mandatory to register the clinical trial according to Art 62 (on transparency) of Law 29/2006 on Medicinal Products and Medical Devices.

There is no general national healthy volunteer registry.

Yes

Art 30 Royal Decree 1591/2009
Royal Decree 1090/2015
Royal Decree 1616/2009
Circular No. 7 of 2004

• CE-marked MD used within label only require approval from EC!

• Combination studies:
(1) MD with CE-marked used outside label or without label + MP: Submission to SGMUH (General Subdirection of Human Medicinal Products') in 2 copies. Evaluation by SGMUH and SGPS (General Subdirection of Medical Devices). Single unified opinion after evaluation process.
(2) MP (not authorized in any EU country) integrated in a MD (e.g. insulin pre-filled pens): Submission to SGMUH (evaluation process like IMP trial)
(3) Comparing MP vs MD with CE mark used within label: Submission to SGMUH (evaluation process like IMP trial)
(4) Comparing MP vs MD without CE mark and/or with CE- mark used outside label: 2 applications (to SGMUH and SGPS). Sponsor notifies the Subdirections of application dates. Evaluation by both the Subdirections. Single unified opinion after evaluation process.

• Observational studies: Submission obligation depends on authorisation status of the IMP and the MD (CE mark and use within or outside label). In case of required authorisation, the trial has to be submitted to both local + national CA. For any other types of clinical research only submission to national CA is required. (see: Orden SAS/3470/2009)