Clinical investigation device – any device intended for use by a suitably qualified medical practitioner when conducting the clinical investigations referred to in section 2.1 of Annex 10 in an appropriate clinical environment of human medicine. For the purpose of conducting a clinical investigation, any other person who, based on their professional qualifications, is authorised to carry out such investigations is accepted as equivalent to a duly qualified medical practitioner.

Goals of clinical investigations are as follows:
(a) to confirm that, under normal conditions of use, devices perform as established by the manufacturer
b) to determine any undesirable side effect under normal conditions of use and assess whether they pose risks in relation to the expected device performance

To approve conduct of the clinical investigation procedure for medical devices, the manufacturer or their authorised representative shall submit an application to the NAMMD, whose template is provided in Annex no. 1 of Order of the Minister of Health no. 792/2006.
The application for authorisation shall be accompanied by the documents provided in Annex no. 2 of Order of the Minister of Health no. 792/2006, as the case may be.
Based on the application form and documents submitted, the NAMMD authorises start of the clinical investigation, according to provisions of Articles 36 and 37 of Government Decision no. 54/2009 or of Article 25 of Government Decision no. 55/2009.
For initiation of the clinical investigation procedure for medical devices, the NAMMD issues the authorisation whose template is provided in Annex no. 3 of Order of the Minister of Health no. 792/2006.

In accordance with legislation on medical devices, conduct of clinical investigations using devices authorized to bear the CE marking does not require authorisation, unless the purpose of such investigations is to use the devices for purposes other than those mentioned in the compliance assessment procedure. Relevant provisions in Annex no. 10 of the directives on devices remain applicable.

Application for Clinical investigation
download document …
download document …
Content of the clinical investigation dossier
download document …
download document …