Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article, in the case of reporting of adverse events pursuant to Article 80(4) and in the case of clinical investigations of combination products between medical devices and medicinal products, where the latter are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014.
Féadfar na nósanna imeachta agus na scálaí ama le haghaidh measúnuithe comhordaithe i gcás modhnuithe substaintiúla de bhun mhír 12 den Airteagal seo a leagan amach freisin i ngníomhartha cur chun feidhme den sórt sin, i gcás tarluithe díobhálacha a thuairisciú de bhun Airteagal 80(4) agus i gcás imscrúduithe cliniciúla ar tháirgí comhcheangail idir feistí leighis agus táirgí íocshláinte, i gcás ina mbíonn na táirgí sin faoi mheasúnú comhreathach de thriail chliniciúil faoi Rialachán (AE) Uimh. 536/2014.