(7) Both Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/745, empower national competent authorities, on a duly justified request, to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health, or in the interest of public health or patient safety or health respectively (‘national derogation').
(7) Direktivama 90/385/EEZ i 93/42/EEZ te Uredbom (EU) 2017/745 ovlašćuju se nacionalna nadležna tijela da, na propisno utemeljen zahtjev, odobre stavljanje na tržište medicinskih proizvoda za koje nisu provedeni relevantni postupci ocjenjivanja sukladnosti, ali čija je uporaba u interesu zaštite zdravlja, od interesa za javno zdravlje ili sigurnost odnosno zdravlje pacijenata („nacionalno odstupanje").