体外诊断自测试剂盒ce认证自测公告号ce认证资料要求

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