The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
Beidh nósanna imeachta doiciméadaithe ag an gcomhlacht dá dtugtar fógra i ndáil le deimhnithe AE maidir le measúnú ar dhoiciméadacht theicniúil agus le dheimhnithe ar scrúdú cineáil AE a athnuachan agus cuirfear de dhualgas, leis na nós imeachta sin ar an monaróir i gceist achoimre a thíolacadh maidir le hathruithe agus le torthaí eolaíocha na feiste, lena n-áirítear an méid seo a leanas: