Form

Guidance for Preparation of Documentation File(s)

Guidance for preparation of documentation file(s) which - shall be submitted to the Notified Body for CE-Conformity Assessments according to AI !! AI !! !! !! I'!! I'!! or which - must be made a(ailable by the manufacturer to the national authorities for EC-Conformity Assessments according to !! !! I'!! I'!! Anne" II Anne" 'II Anne" I'$ Anne" III$ Item &)# Item & Item &)# Item & Technical Documentation Technical Documentation Design Dossier Device Documentation) Anne" #$ Anne" &$ Anne" II$ Anne" III$ Anne" I'$ Anne" '$ Item % Item & Item % Item & Item % Item & Design Dossier Device Documentation Design Dossier Device Documentation Design Dossier Device Documentation

In general$ the documentation has to be in such detail that the design$ manufacture and the designed performances of the product can be e(aluated$ in order to pro(e compliance to the pro(isions of the AI !! *+,&-.,EEC and the !! *&,%#,EEC$ respecti(ely) /) Application form (see 01' 21! 324s form5) #) 3hotographs (photo documentation) preferred si6e A% colored &) 7ser manual(s) intended for the European mar8et incl) periodical safety tests %) General description of the product(s) including the classification ( !!$ Anne" I9) and intended use %a) :ist of accessories$ adapters and other de(ices or e;uipment which are intended to be used in combination with the de(ice system .) 2pecifications and performance data of the product(s) as claimed <) General description of any (ariants planned =) >is8 analysis report incl) implemented ris8 control measures,methods (EN /%=*/) -) :ist of standards referred to in Article . related to the product de(elopment) Appropriate proof to show conformance to the directi(e in the case where the standards applied are either not mentioned in Article . of the !irecti(e or are not applied in full or no standards are applied at all) ? essential re;uirements according to Anne" /, I of the AI !!, !!,I'!! (e)g) in the form of a chec8list) ? internal manufacturer standards ? any applicable regulatory standards ? current state of technology (state of the art techni;ue)

File: MED_F_03.05E

Revision: 3

Effective: 2010-02-01

Page 1 of 2

Form

Guidance for Preparation of Documentation File(s)

*)

Electrical , mechanical , chemical constructional data including drawings$ descriptions$ and e"planations necessary to understand the drawings , diagrams and the operation of the product(s)

/+) Clinical data referred to in Anne" =,AI !! or Anne" 9, !! respecti(ely) performance e(aluation data referred to in Anne" 'III,I'!! /+a) Clinical ris8 to intended benefit analysis e)g) final ris8 assessment whether the residual technical and clinical ris8s are acceptable in regard to the intended benefits and performance of the (implantable) de(ice system //) !esign (erification, ;ualification, (alidation documents //a) !esign @A Plan (see essential re;uirements chec8list as defined in section -)A (for 2oftware$ a 2oftware-'alidation 3lan can be re;uired5) //b) @ualification test reports containing test results based on applicable standards (as defined in section -)) (Especially for I'!BsC test reports on stability)) //c) 2ummary report on satisfactory completion of the acti(ities in the !esign @A 3lan /#) If the product(s) is,are to be connected to other product(s)$ proof must be pro(ided for conformity to the essential re;uirements when connected to any such product(s) ha(ing the characteristics specified by the manufacturer /&) :abeling layouts for the complete system$ including sterile and storage pac8aging) /%) anufacturing flow chart highlighting the tests which were designed to ensure compliance to the essential re;uirements of the respecti(e edical !irecti(e) (In case of list A I'!BsC Additionally batch release protocol))

/.) A declaration as to whether a substance$ which is referred to in Anne" /$ section /+,AI !! or in Anne" I$ section =)%, !! is incorporated in the de(ice along with documentation concerning the appropriate test (if applicable) /<) !escription of the method of sterili6ation including appropriate proof of (alidation (if a(ailable) /=) D(er(iew of pre(iously regulatory appro(als (if a(ailable)
Note: If you need more information please contact your responsi le department at T!" #!D Product #ervice$

File: MED_F_03.05E

Revision: 3

Effective: 2010-02-01

Page 2 of 2