CATrialAuthorisation object

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

MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP
NB: Pre-submission meetings with potential sponsors of clinical investigations are encouraged by HPRA

Yes

Only certain types of clinical investigation involving MD require notification and review by the HPRA prior to commencement:

(1) Clinical investigations that are likely to require notification and review by the HPRA prior to commencement include:
- New devices
- Modification of an existing device
- Device containing untested materials
- Device materials used in a different location or for a different duration
- Device proposed for a new function

Related details are specified in the guidance document describing the circumstances when notification and review are required: 'Guide for Manufacturers and Sponsors on Clinical Investigations Carried out in Ireland’ (available on the HPRA website in section: About us>Publications&Forms>Guidance Documents)
Any queries regarding the type of device investigations requiring notification and review can be submitted to HPRA.

(2) Device investigations that are proposed designed and sponsored by clinical investigators rather than medical device manufacturers, solely for the purposes of clinical or academic research with no commercial intent, may not require review by the HPRA prior to commencement. In such instances, investigational devices should be used within acceptable professional and ethical boundaries and for the purposes of research only. This also applies to cases when:
- device investigations are conducted without the financial support of the manufacturer,
- when it is not planned to use the data generated as part of an application for conformity assessment
- when there is no intent to seek commercial gain on the basis of the clinical data that are generated.

(3) In-vitro diagnostics: It should be noted that there is no specific legislation relating to clinical investigations involving in-vitro diagnostic medical devices. Rather, in-vitro diagnostic medical devices have to undergo performance evaluation as specified under Annex VIII of the In-vitro Diagnostic Medical Devices Directive 98/79/EC.

In parallel