MDStudy object

Yes

Definitions according Regulation (2) of S.I No. 110 of 2009, amending the Principal Regulation S.I No. 252/1994:

(1) “device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
(iii) investigation, replacement or modification of the anatomy or of a physiological process, or
(iv) control of conception; and
(v) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means;

(2) “intended for clinical investigation” means, in relation to a device, that it is— (a) intended for use by a registered medical practitioner user when conducting investigations of that device in an adequate human clinical environment; or (b) for use by any other person who by virtue of his or her professional qualifications is authorised to carry out investigations of that device in an adequate human clinical environment;

No

Clinical investigation (Definition according to ISO Standard 141555:2011): “…any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device”