检测试剂需要符合的欧盟指令是IVDD（98/79/EEC）体外诊断器械指令
Required documents
The copy of National Court Register document or certificate ofcentry in the register of business activity
The witten declaration that no application for product asessmenthas been submitted to another Notified Body
The witten dee laration that no medical ine idents involving themedical device applied for certification have been ocurred
The Manufacturer s commitment to maintain the procedures ofregular review of experience gained with the in wiro diagnostic
medical device subsequent to its being placed on the market
The Manufacturer's commitment to fulfil the obligations resutingfrom his Assurance System
The Manufacturer S commitment to maintain the ffectiveness ofthe Assurance Systerm
The Manufacturer's commitment to maintain the procedure inaccordance with the chapter 9 of the Act on Medical Devices(the
Polish Act) in case of rceiving an infomation on medicalincident
The Authorised Representative 's wrten statement aboutcoopenation with Manufacturer (if applicable)
The description of the type of product including variants andthe list of diferences between variants
The essential re checklist (Annex 1 to the Regulationof the Minister of Health of 17 February 2016 on essential
re and conformity asessment procedures of in virodiagnostic medical devices as amended (Journal of Laws of the
Republic of Poland 2016. item 211)
The design drawings. the specifications of components and purts,cirecuit diagrams
The results of the design calculations
Diagram of the manufacturing process including themid-production inspection with indication of subcontractedstages
The list of harmonized standards applied in whole or in the partand other applied standards
Description of meeting the essential re. if they arenot based only on the harmonized standards
Test reports showing conformity with re of harmonizedstandards and/or Common Technical Specifications
Performance evaluation data confirming parameters declared bythe manufacturer
Stabllity testing data confirming the stability declared by themanufacturer
Report of testing with participation of non-professional users(if applicable)
Declaration of conformity of the in wiro diagnostic medicaldevice
Risk management and risk analysis, including: Report of riskanalysis for conformity with PN-EN ISO 14971/EN ISO 14971
A draft marking (label), package (in case of translation ofinformation documents, a formal confirmation from translationagency
shall be atached)
Instructions for use of a medical device (in case of translationof infomation documents, a fomal confirmation from translation
agency shall be atached)
Information on the in wiro diagnostic medical devicerestrictions
Information on the origin and conditions under which humantssues are derived or substunces derived from these tssues -refers
to medical devices containing human tssues or substances derivedfrom thesc tssues
Brochures, folders, presentations and other promotionalmaterials conceming in witro diagnostic medical devices prepared bythe
Applicant (in case of tanslation of information documents. afomal confirmation from translation ageney shall be atached)
List of all suppliers and subcontractors, indicating key critical suppliers subcontractors; ertificates ofsuppliers/subcontractors (if
applicable)
Product sample to be consulted with the PCBC
。 Manual + Policy and Obiectives
1 Organizational chart and responsibilitieis and competencies ofthe management
Document and recond control procedure
Risk management pxocedure
Desigming proeedure
Manufacture procedune
Proeedure for the purchasing and subcontractors' control
Noncomplying device control procedure
Correetive and preventive actions proedure
Sericing proccdure if applicable)
Sterilization procedlure (if applieable)
h vitro diagnostic medical dev ice ilentifieation and raccbilityprocedure
Product security procedure
Measuring e supervision procedure
Proedure for obraning the fedback from useTs concerming product(data analyisl
Proeedure for the 1esting of m ritro diagnostic mdical deviceduring the manfactures process orland testing of final produnct
Intcmal audit procedure
Product measurcement proedure
Proeedure for isuance and implemenation of advisory notes
Procedure for dealing in case of medical incidents
Proeedure for regular review of experienee gained with thedevice subsoquent 10 its being placed on the market
