substance, human blood derivative or human tissue engineered product, taking account of the intended purpose of the device, — a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, — the solutions adopted as referred to Annex I, Section I(2), — the preclinical evaluation, — the clinical evaluation referred to in Annex X, — the draft label and, where appropriate, instructions for use." (b) In Section 5 the second and third paragraphs are replaced by the following:
En arrêtant sa décision, l'organisme notifié prend dûment en considération l'avis de l'EMEA.