Effective Date: 21 Aug 2018 Issued: 06 Aug 2018 Issue: 3 SI No: P3282 Prepared: K. Osborne. Reviewed by: G. Ostacchini

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1 Page 1 f 11 Effective Date: 21 Aug 2018 Issued: 06 Aug 2018 Issue: 3 SI N: P3282 Prepared: K. Osbrne Reviewed by: G. Ostacchini Apprved by: M. Sanders Date: 06 Aug 2018 (DD/MMM/YYYY) Title: Device Technical File Prcedure Date: 07 Aug 2018 (DD/MMM/YYYY) Date: 08 Aug 2018 (DD/MMM/YYYY) 1. Intrductin 1.1. The Medical Device Directive 93/42/EEC (MDD) and the Medical Device Regulatin (MDR) state that a technical file fr each medical device is created, maintained and updated by the rganisatin placing the device n market. 2. Scpe 2.1. Develpment r updating f technical files fr medical devices that Haag Streit UK Ltd, Clement Clarke Internatinal Ltd and Jhn Weiss & Sn Ltd are intending t place n the market including all legacy prducts that are already in the market place as well as devices prvided by third party manufacturers (r Original Equipment Manufacturers - OEMs) Technical files are held in electrnic frmat nly All PDF cpies must be in a wrd searching frmat Only PDF cpies are issued t external custmers n the apprval f the Grup QA/RA Manager. 3. Definitins Term Definitin BOM Bill f Materials OEM Original Equipment Manufacturer VMA Virtual Manufacturer Agreement 4. Internal & External Dcuments 4.1. Internal dcuments P0740 Cmpiling technical dcuments. P0745 External dcument cntrl.

2 Page 2 f 11 P0766 Cntrl f internal dcuments prcedure. P0041 CAPA 4.2. External dcuments BS EN ISO 13485: Medical devices, Quality management systems requirements fr regulatry purpses. BS EN ISO 14971:2012 Medical devices Applicatin f risk management t medical devices Medical Device Directive 93/42/EEC with all amendments. Medical Device Regulatin 2017/745* Virtual Manufacturing MHRA (Own-Brand-Labelling-tVirtual-Manufacturing-Final) NB-MED/2.5.1/Rec5 Technical dcumentatin *in transitin perid 5. Respnsibilities 5.1. Quality Assurance Administratrs T gather the infrmatin frm the relevant design utput dcuments and prductin transfer t prductin prcess and cllate the infrmatin int the agreed technical file frmat. Maintain the technical files t the individual requirements based n Appendix A. Keep the frmat f the technical files cnsistent t the detail f this prcedure. Update technical files thrugh ECR changes and recrd ECR number n revisin histry. Update the Technical File Matrix with changes and review dates 5.2. Quality Assurance/Regulatry Affairs Officers T review the status f the files and suggest and in sme cases prvide additinal infrmatin fr inclusin in t the technical files frm prduct testing, material specificatin etc. Participate in Technical File reviews 5.3. Quality Cntrl Manager T prvide inspectin and test prcedures, test reprts and any ther Quality

3 Page 3 f 11 Cntrl related dcuments fr the technical file Technical Manager/Design and Develpment Manager/Head f Manufacturing Services Prvisin f infrmatin t the Quality Assurance Administratrs as new prducts becme available thrugh the Design and Develpment prcess. This will include pre and pst market and legacy infrmatin if available. This will include, but nt exhaustive f, the fllwing types f infrmatin: Technical infrmatin including descriptin, class and intended use statement. Risk assessments including risk plan, FMEA and risk management reprt frm the Design prcess. Validatin dcumentatin. Clinical dcumentatin. Pst marketing clinical fllw up plan (including pst marketing clinical fllw up where applicable). Manufacturing dcumentatin and data (drawings / layuts / Bill f materials and Rute details). Labeling, Instructins fr use. Essential requirement check list Design prcess. Material infrmatin including relevant ISO data. Patient infrmatin, intended use and market infrmatin. Engineering Change Request (ECR) changes and sheets are passed t Quality Assurance administratrs fr ntificatin f any and all changes t the device. All changes will require a risk assessment t address the implicatins f the change and any pssible regulatry cnfrmance issues. A PDF cpy f the ECR is held in the technical file. Participate in Technical File reviews 5.5. QA/RA Team Leader Peridic reviews f the technical file prcedure and its peratin and t request changes if needed. Signatry t Declaratin f Cnfrmities. Oversees QA Administratin maintenance f Technical Files.

4 Page 4 f Grup QA/RA Manager Participates in technical file reviews Signature t Declaratin f Cnfrmities Apprves Technical file cre dcuments fr inclusin Identifies and plans fr new requirements and technical file updates. 6. Methd 6.1. Technical files may be prepared fr individual devices r device families. These can be fund in the fllwing lcatin: \\cch-fp02\qa_data\qa Technical Files Write access t these files is restricted t the Quality Assurance Department Structure f technical files 0) Technical File Index 1) General Device Details 2) ERCL (Essential Requirements Checklist) 3) Risk Management File 4) Cmpliance 5) Validatin 6) Clinical Evaluatin 7) Labelling 8) Patient Infrmatin 9) Manufacturing 10) D f C (Declaratin f Cnfrmity) 11) Prduct Registratins 12) Archive 6.3. Quality Assurance Administratrs gather the infrmatin supplied by the Technical, Quality Cntrl and Prductin Engineering Departments and cllate the infrmatin int the technical file fr the device/family and apply any updates t the infrmatin

5 Page 5 f 11 as required. The Technical File Matrix is updated t ensure all review dates are visible Any additinal r missing infrmatin is t be requested immediately frm the apprpriate department and nted n the Technical File Matrix. The QA/RA Team Leader will als be ntified, if the dcumentatin is nt prvided within 2 weeks the request will be escalated t the Grup QA/ RA Manager Updates t technical files Quality Assurance Administratrs use the ECR prcess t review updates and changes t the prducts that may include changes t the technical file. The changes are recrded n the revisin histry fr the technical file Technical files are in a cnstant state f review and update as intended by the MDD and prduct changes within the ECR prcess Dcuments may be prvided by external surces particularly critical subcntractrs and Virtual Manufacturers (VMA) Mnitring and Measurement The Technical File Matrix dcuments when the files are last reviewed internally and by the Ntified Bdy The Matrix will include the review/expiry date f any dcuments within the file. This prvides the mechanism t update prir t expiry/review Technical file reviews are held annually (12 mnths) frm the initial prduct release date and will be led by the QA/RA Team Leader and invlve at a minimum: Technical Manager Design and Develpment Manager Head f Manufacturing Services Grup QA/RA Manager This ensures all aspects are cvered and any actin addressed thrugh P0041 CAPA.

6 Page 6 f 11 Appendix A Technical File Cntents Table 1 belw is fr guidance nly, variatin will exist depending n device/family type and class. Table 1: Example Technical File Cntents Sectin Infrmatin t include Prduct Schedule (including UDI when available) describing variants and accessries, prduct cdes, GMDN 1 General Device Details Prduct Specificatin (including name/trade name, weights, dimensins etc.) Technical Specificatin Medical device classificatin dcument (MDC) including reference t prduct schedule fr GMDN 2 ERCL (Essential Requirements Checklist) Essential requirement checklist (ERCL) is required under the MDD t demnstrate cnfrmity (MDD Annex I). Harmnised Standards List f standards including issue date and whether partial r full cmpliance is claimed. Fr partial cmpliance a justificatin must be included Risk management plan (RMP) with clear links t PMS and CER activities 3 Risk management file Preliminary Hazard Analysis (HA) reprt Risk Management Reprt (RMR) including individual and verall risk benefit analyses 4 Prduct Cmpliance/verificatin Cpies f Test reprts carried ut t perfrmance standards where harmnised standard exist t be used (e.g. EN ISO series) Supprting Prduct claim reprts Reprts supprting cmpliance with finished device specificatins Reprts shwing cmpatibility with substances that can cme int cntact with the device (e.g. medicines, fluids, gases etc.)

7 Page 7 f 11 Sectin Infrmatin t include Cpies f all Validatin test reprts including if applicable: Electrical safety and EMC test reprts (eg. BS EN X). Rhs2 and WEEE cmpliance data.(electrical nly) Reach cmpliance data. Validatin dcuments fr critical manufacturing prcesses e.g. mulding, gluing/bnding, cleaning, sterile barrier sealing etc. 5 Validatin reprts Reprts demnstrating suitability f devices when used with ther devices r accessries Reprts demnstrating accuracy f measuring functins Sftware verificatin/validatin reprts (e.g. t EN 62304) Usability testing (EN62366/ ) Shipping validatin t shw the device meets its specificatin after strage, transprtatin/shipping Where applicable fr all sterile devices: Reprts shwing cmpliance with relevant sterilisatin standard (e.g. EN ISO 11135, /2, , series) Fr Ethylene Oxide sterilisatin ensure validatin prtcl, reprt, residuals reprt, EO gas specificatin, bilgical indicatrs and last requalificatin review are present. 5.1 Sterilisatin validatin Fr radiatin sterilisatin include dse setting/dse substantiatin dcuments, ratinale if cnducted fr device family, dse audit reprts, prcess validatin prtcl and reprt Determinatin f biburden including validatin fr test methd and biburden results Sterility testing including validatin f test methd. Technical agreements with sterilisatin cmpany Fr devices supplied nn-sterile fr sterilisatin by user

8 Page 8 f 11 Sectin Infrmatin t include Validatin dcumentatin fr sterilisatin/reprcessing instructins (ref EN ISO 17664) Fr devices supplied nn-sterile and cleaned by user Dcumentatin t validate cleaning instructins Dcuments t shw that device will meet its specificatin at the end f its in-use life including accelerated and real time aging studies (if applicable). Bilgical evaluatin shuld be based n the finished device and shuld cnsider all materials, manufacturing and sterilisatin prcesses, degradatin prducts, leachables etc. Bilgical Evaluatin Reprt accrding t ISO and cpies f related bicmpatibility test reprts. Results f any simulated use and animal tests 6 Clinical data (pst and pre) A Clinical Evaluatin Reprt cnducted in accrdance with relevant versin f MEDDEV t include the fllwing: Clinical Evaluatin Plan Literature Search Reprt Clinical Evaluatin Reprt Cpies f any Clinical Study Reprts (where applicable) shwing cmpliance t EN ISO 14155, Annex X and MEDDEV 2.7/4 6.1 PMCF Dcumentatin relating t PMCF in accrdance with MED DEV 2.12/2 r justificatin as t why PMCF is nt required. Under MDR PMCF Plan and Reprt r justificatin why PMCF is nt applicable 6.2 Pst Market Surveillance This sectin shuld include the fllwing: A PMS Plan that defines practive and reactive PMS prcesses.

9 Page 9 f 11 Sectin Infrmatin t include A PMS Reprt that reviews infrmatin btained frm these activities including sales data (by year and gegraphical area), cmplaint data (by cmplaint type, year and gegraphical area), service data, adverse incident reprts, FSCAs, crrective actins and their impact n risk management, Clinical Evaluatin Reprts and the requirement fr any PMCF. Under the MDR: PSUR Peridic Safety Update Reprt summarises the results and cnclusins f the analyses f the pst-market surveillance data. See Article 86 f the MDR Labels shuld be in the language accepted by the Member State where the device will be sld: 7 Labelling Cpies f all labels n bth primary and secndary packaging List f symbls used in cmpliance t ISO :2016 Verificatin f labelling translatins 8 Patient infrmatin Instructins fr Use r justificatin if n IFU supplied Labelling manual cleaning/ hygiene instructins. Manufacturing prcess flw chart including inputs, subcntracted elements, and assciates prcedures (live dcuments extracted frm QMS/flders). Cpies f Inspectin prcedures, bth Gds Inward fr critical parts and in-huse manufacturing, if applicable. 9 Manufacturing Quality Plan fr prducts which have critical subcntracted elements. This will include Names f critical subcntractrs Certificatin/qualificatin f critical subcntractrs Technical Agreement with critical subcntractrs. Fr OEM manufacturers cpies f the Virtual Manufacturing Agreement is in place. Virtual Manufacturing Statement

10 Page 10 f 11 Sectin Infrmatin t include Drawings and BOM fr critical cmpnents and finished device 10 Declaratin f Cnfrmity (DC) Packing infrmatin Packaging Specificatins Bx sizes/layuts Specificatin f cmpnents, sub-assemblies, raw materials etc e.g. MSDS. D f C with links t, Essential requirements, Harmnised Standards and prduct schedule. 11 Prduct Registratins FDA etc., Details f cuntries where registered where applicable.

11 Page 11 f Revisin Histry Prepared by: Reviewed by: Apprved by: Revisin Versin: Date: Reasn fr change: P. Rbinsn D. Harvey & N. File M. Sanders 1 31/07/2014 Prcedure Originated H. Taylr G. Ostacchini M. Sanders 2 04 Aug 2015 Updated sectin 7 t include lcatin f the spreadsheets. Als crrected sme grammatical errrs and added the prcedure names t crrespnd with the numbers in the internal dcuments sectin. Update sectin 4.0 external dcuments t crrect regulatin reference titles. Update t imprve MDD cmpliance as well as mve twards MDR cmpliance K. Osbrne G. Ostacchini M. Sanders 3 06 Aug 2018 Update t current technical file structure. And update t respnsibilities. Inclusin f technical file review and parties invlved.