医疗器械认证规范.pdf

NBOG’s Best Practice Guide applicable for ⌧ AIMD, ⌧ MDD, and ⌧ IVDD 2009-1 Guidance on Design-Dossier Examination and Report Content 1 Background The objective of this document is to give guidance to: – the Notified Bodies (NB) of the type of content expected of the Notified Body Design Dossier Reports of Medical Device manufacturers to ensure manufacturer’s confor- mance to the relevant Directive – the Assessors of the Designating Authorities (DAs) on the content expected in the Notified Body’s Design Dossier Report 2 Scope 2.1 AIMD 90/385/EEC, MDD 93/42/EEC, as amended by 2000/70/EC and 2001/104/EC, IVD 98/79/EC, and TSE 2003/32/EC 2.2 Design Dossier Review: Examination of the design of the product is required to be carried out by the Notified Body in: – the Active Implantable Medical Device Directive 90/385/EEC section 4 of Annex II and section 4 of Annex 3 (design dossier related part of type-testing examination) – the Medical Devices Directive 93/42/EEC section 4 of Annex II and section 4 of Annex III (design dossier related part of type-testing examination) – the in-vitro diagnostics Medical Device Directive 98/79/EC section 6 of Annex III, section 4 of Annex IV, and section 4 of Annex V (design dossier related part of type- testing examination) – the “TSE Directive” 2003/32/EC Article 5 3 General 3.1 The NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate. 3.2 The NB should ensure that the manufacturer’s applica