A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
Monaróir feiste ar taispeánadh go bhfuil an fheiste mhodhnaithe coibhéiseach leis an bhfeiste a cuireadh ar an margadh, ar feiste é nach ndearna sé féin í a mhonarú, féadfaidh sé brath ar mhír 4 freisin chun gan imscrúdú cliniciúil a dhéanamh, ar choinníoll gcomhlíontar na coinníollacha uile seo a leanas de bhreis ar a cheanglaítear sa mhír sin: