Prior to the start of manufacture, the manufacturer shall prepare documents defining the manufacturing process, in particular as regards sterilisation where necessary, together with all routine, pre-established procedures to be implemented to ensure homogeneous production and, where appropriate, conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.
Sula dtosóidh sé ag monarú, ullmhóidh an monaróir doiciméid ina saineofar an próiseas monaraíochta, go háirithe maidir le steiriliú nuair is gá sin, agus na gnáthnósanna imeachta réamhbhunaithe atá le cur chun feidhme chun táirgeacht aonchineálach a áirithiú agus, nuair is iomchuí, lena áirithiú go bhfuil na táirgí i gcomhréir leis an gcineál a bhfuil tuairisc air sa deimhniú ar scrúdú cineáil AE agus leis na ceanglais de chuid an Rialacháin seo a bhfuil feidhm acu maidir leo.