Product And Process Change Notification Form (MDD, AIMD)



SECTION A - Change Description and Assessment To be completed by ManufacturerManufacturer Name and AddressContact Person(s) (name, email, phone)Certificate(s) / Scope(s) / Device Name(s) (List certificates/scopes/products affected by this change)Classification of Device(s)(Device classification, rule and Directive) Description of Change(Provide a detailed description and the reason for the change)Physical address of Authorized Representative will change to:Prinsessegracht 202514 AP The HagueThe NetherlandsMANUFACTURER EVALUATION OF CHANGEThe Manufacturer should evaluate how the change impacts each of the sections listed below. Manufacturer should consider if the change/s have resulted in an update, evaluation/re-evaluation of any the following: Risk analysis, Essential Requirements, clinical evaluation, PMS/PMCF plan, any product verification/validation?Intended PurposeManufacture and Design locationSignificant SubcontractorsManufacturing(this includes, but not limited to: Changes to manufacturing locations, processes, process validation, product qualification )Device Construction and MaterialsUser Information (Labels, IFU)Physical address of Authorized Representative will be updated.Design Requirements, Verification and Validation DataEssential Requirements ComplianceRisk ManagementClinical EvaluationPMS/PMCFBiological SafetySterilisation validationPackagingIntegrity testingTransit testingShelf life and Stability testingProduct LifetimeSoftwareMedicinal Substances / Human Blood DerivativesAnimal Derived Substances UtilisedEnergy SourceOther(Additional information and/or impact assessment that does not fall into any of the categories above)Is this Change Considered to be Significant?Please provide a justificationList of documents updated as a result of this changeBSI may request these documents for reviewName and Signature: Position:Date:SECTION B – BSI ASSESSMENT To be completed by BSI Scheme Manager/Product Technical onlyBSI Comments, Proposed Actions and ConclusionName Date ................
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