{"id":4800,"date":"2017-04-11T12:07:20","date_gmt":"2017-04-11T12:07:20","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=4800"},"modified":"2023-07-13T11:13:58","modified_gmt":"2023-07-13T08:13:58","slug":"investigatie-clinica","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/investigatie-clinica\/","title":{"rendered":"Clinical investigation"},"content":{"rendered":"

Clinical investigations with medical devices and assessment of performance with in vitro diagnostic medical devices<\/strong><\/p>\n

\u201dClinical investigation\u201d<\/strong>\u00a0\u2013 any systematic investigation involving one or several human subjects, conducted to assess the safety or performance of a medical device;<\/p>\n

\u201dPerformance study\u201d<\/strong>\u00a0\u2013 a study conducted in order to establish or confirm the analytical or clinical performance of a device;<\/p>\n

\u201dPerformance assessment\u201d<\/strong>\u00a0\u2013 assessment and analysis of data in order to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device;<\/p>\n

\u201dDevice subject to investigation\u201d<\/strong>\u00a0\u2013 a device which is assessed in the context of a clinical investigation;<\/p>\n

\u201dIn vitro diagnostic medical device subject to a performance study\u201d<\/strong>\u00a0\u2013 a device intended by the manufacturer to be used in a performance study.<\/p>\n

A\u00a0device\u00a0<\/strong>intended to be\u00a0used for research purposes, without any medical objective<\/strong>, is not considered a device subject to a performance study;<\/p>\n

\u201dDevice performance\u201d (for in vitro diagnostic medical devices)<\/strong>\u00a0\u2013 the ability of a device to fulfil its intended purpose as indicated by the manufacturer. This consists of the analytical performance and, as the case may be, of the clinical performance which justifies the respective proposed purpose;<\/p>\n

\u201dAnalytical performance\u201d<\/strong>\u00a0\u2013 the ability of a device to correctly detect or measure a particular analyte;<\/p>\n

\u201dClinical performance\u201d\u00a0<\/strong>\u2013 the ability of a device to produce results correlated with a particular clinical condition or physiological or pathological condition or physiological or pathological process in accordance with the intended target population and user;<\/p>\n

Clinical investigation endpoints:<\/p>\n

(a) establishing and verifying whether the performance of the devices is as established by the manufacturer.
\n(b) establishing and verifying a device\u2019s clinical benefits as specified by its manufacturer;
\n(c) determining any undesirable adverse reaction under normal circumstances of use and whether these are considered risks in relation to the device\u2019s intended performance.<\/p>\n

In order to approve the conduct of a clinical investigation, the sponsor\/authorised representative submits an application to the NAMMDR; the form is available online:\u00a0<\/strong>https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/mdcg_2021-8_annex1.pdf<\/strong><\/a>. Depending on the risk class of the device, the existence of the CE mark and the purpose of the clinical investigation, this can be adapted.<\/strong><\/p>\n

The application is registered only if accompanied by proof of payment of the fee in line with Order of the Minister of Health no. 3467 of November 17, 2022, Annex 1, point 3 – Clinical investigation<\/p>\n

(https:\/\/www.anm.ro\/_\/DM\/LEGISLATIE\/Ordin%203467-2022.pdf<\/a>)<\/p>\n

The form for payment of the fee can be downloaded from the Forms and fees \/ Medicinal products page:<\/p>\n

https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/<\/a><\/p>\n

Following completion of the form for payment of the fee, this shall be submitted to the NAMMDR headquarters of 48 Aviator Maior \u0218tefan S\u0103n\u0103tescu, Sector 1, 011478, Bucharest, and the respective request shall be invoiced by the NAMMDR. After making the payment and confirming it, you can register your application at the NAMMDR headquarters of 58 Nicolae Titulescu, Sector 1, 011144, Bucharest.<\/p>\n

The NAMMDR approves applications for conduct of clinical investigations and clinical performance studies only if accompanied by an ethical opinion issued by the National Bioethics Committee for Medicinal Products and Medical Devices (CNBMDM) and by the documents provided for in Annex XV of the MDR and Annex XIV of the IVDR, as required. The CNBMDM can be contacted at:\u00a0http:\/\/www.bioetica-medicala.ro<\/a>;\u00a0https:\/\/www.adsm.ro\/comisia-de-bioetica-a-medicamentului-si-a-dispozitivelor-medicale\/<\/a>; email:\u00a0comisia.bioetica@gmail.com<\/a>.<\/p>\n

The structure and the Regulation for organisation and operation of the National Bioethics Committee for Medicinal Products and Medical Devices (CNBMDM) are approved through Order of the Minister of Health no. 80\/2023.<\/p>\n

Clinical investigations with medical devices and clinical performance assessment studies with in vitro diagnostic medical devices are conducted in compliance with the principles of good clinical practice, in accordance with the SR EN ISO 14 155<\/strong> and ISO 20 916<\/strong> standards. The NAMMDR and the Medical Devices assess and validate requests for changes and assess and authorise the files for clinical investigations, as well as their substantial changes, according to:<\/p>\n