1. 自测版试剂盒CE认证需要准备哪些资料？
答：请参考以下资料清单：
Re（TakeNB1434 as an example） | |
Statements andComnitments | The copy ofNational Court Register document or certificate of entry in theregister of business activity |
The writtendeclaration that no application for product assessment has beensubmitted to another Notified Body | |
The writtendeclaration that no medical incidents involving the medical deviceapplied for certification have been occurred | |
TheManufacturer’s commitment to maintain the procedures of regularreview of experience gained with the invitro diagnostic medicaldevice subsequent to its being placed on the market | |
TheManufacturer’s commitment to fulfil the obligations resulting fromhis Assurance System | |
TheManufacturer’s commitment to maintain the effectiveness of the Assurance System | |
TheManufacturer’s commitment to maintain the procedure in accordancewith the chapter 9 of the Act on Medical Devices (the Polish Act)in case of receiving an information on medical incident | |
The AuthorisedRepresentative’s written statement about cooperation withManufacturer (if applicable) | |
Technicaldocumentation of the medical device | Thedescription of the type of product including variants and the listof differences between variants |
The essentialre checklist (Annex 1 to the Regulation of the Ministerof Health of 17 February 2016 on essential re andconformity assessment procedures of invitro diagnostic medicaldevices as amended (Journal of Laws of the Republic of Poland 2016,item 211) | |
The designdrawings, the specifications of components and parts, circuitdiagrams | |
The results ofthe design calculations | |
Diagram of themanufacturing process including the mid-production inspection withindication of subcontracted stages | |
The list ofharmonized standards applied in whole or in the part and otherapplied standards | |
Description ofmeeting the essential re, if they are not based only onthe harmonized standards | |
Test reportsshowing conformity with re of harmonized standards and/orCommon Technical Specifications | |
Performanceevaluation data confirming parameters declared by themanufacturer | |
Stabilitytesting data confirming the stability declared by themanufacturer | |
Report oftesting with participation of non-professional users (ifapplicable) | |
Declaration ofconformity of the invitro diagnostic medicaldevice | |
Riskmanagement and risk analysis, including: Report of risk analysisfor conformity with PN-EN ISO 14971/EN ISO 14971 | |
A draftmarking (label), package (in case of translation of informationdocuments, a formal confirmation from translation agency shall beattached) | |
Instructionsfor use of a medical device (in case of translation of informationdocuments, a formal confirmation from translation agency shall beattached) | |
Information onthe invitro diagnostic medicaldevice restrictions | |
Information onthe origin and conditions under which human tissues are derived orsubstances derived from these tissues - refers to medical devicescontaining human tissues or substances derived from thesetissues | |
Brochures,folders, presentations and other promotional materialsconcerning invitro diagnostic medicaldevices prepared by the Applicant (in case of translation ofinformation documents, a formal confirmation from translationagency shall be attached) | |
List of allsuppliers and subcontractors, indicating key criticalsuppliers/subcontractors; certificates of suppliers/subcontractors(if applicable) | |
Product sampleto be consulted with the PCBC | |
Manufacturer Assurance System documentation | Manual+ Policy and Objectives |
Organizationalchart and responsibilities and competencies of themanagement | |
Document andrecord control procedure | |
Riskmanagement procedure | |
Designingprocedure | |
Manufactureprocedure | |
Procedure forthe purchasing and subcontractors’ control | |
Non-complyingdevice control procedure | |
Corrective andpreventive actions procedure | |
Servicingprocedure (if applicable) | |
Sterilizationprocedure (if applicable) | |
Invitro diagnostic medicaldevice identification and traceability procedure | |
Productsecurity procedure | |
Measuringe supervision procedure | |
Procedure forobtaining the feedback from users concerning product (dataanalysis) | |
Procedure forthe testing of invitro diagnostic medicaldevice during the manufacture process or/and testing of finalproduct | |
Internal auditprocedure | |
Productmeasurement procedure | |
Procedure forissuance and implementation of advisory notes | |
Procedure fordealing in case of medical incidents | |
Procedure forregular review of experience gained with the device subsequent toits being placed on the market | |
