Common use of Customer’s liabilities Clause in Contracts

Customer’s liabilities. 3.1 The customer shall give NOTICE documents related to manufacturing, service places, facilities and activities covered by NOTICE’s service scope. All changes occurring in this regard shall be communicated to NOTICE in written. 3.2 The customer sends NOTICE the related documentation and give them access for document examination. 3.3 The customer allows auditors to enter facilities, access system and records as agreed in different stages of services. 3.4 The customer will not conceal from NOTICE any information related to the services. 3.5 In the framework of relevant common specification, standard, regulations and other documents published or accepted by MDCG, the customer is obliged to comply with any kind of written or verbal information and instruction taken from NOTICE for operation of the management system, product conformity assessment, inspection and testing services. 3.6 The customer whose management system or the product related to the management system is certified shall assign one of the personnel for ensuring the implementation and continuity of the established system, provide auditors’ access to all the required areas in working hours, guarantee the provision of all national legislations or special requirements apart from the management system standard. 3.7 Auditors in the training process, observers or guides can accompany NOTICE in the inspections, audits or unplanned visits carried out in the customer’s site. Observer may be there to observe a member of audit/ inspection team, may be an authorized person of customer, accreditation body or the related ministry. Guides are individuals accompanying the audit team for assistance. Any member of the audit team can be assigned as guide. Guide’s responsibilities may include making communications, arranging meetings, organizing site audit, having site safety regulations applied, witnessing the audit on behalf of the customer, or providing the information requested by the auditor. 3.8 The customer is obliged to declare any kind of verbal or written information to NOTICE personnel, TURKAK representatives or authorities of Ministry of Health of Turkey regarding audit or inspection activities while necessary. 3.9 The customer shall inform NOTICE within duration specified in the Certification Agreement of changes in management system or the certified product related to the management system, the company’s system, or products in the certificate scope after certification and changes affecting system’s structure (address(es), scope, number of workers, number of branches, address of branch(es), etc.) 3.10 The customer shall maintain all the records related to the activities carried out by NOTICE (agreement, report, QMS records, etc.) for the certificate validity period as well as the product in the certificate scope for its shelf life. If the periods given for the storage of the relevant standard or regulation/regulation documents and records are longer, this period is valid. 3.11 The customer shall make all the necessary documents for the application available to NOTICE before the inspection and audit. 3.12 NOTICE can carry out inspections or audits in order to evaluate the effect of the applied changes on the system or product. 3.13 In the scope of the certificate the customer shall record the complaints received from its customers or third parties and shall inform NOTICE of the complaints during the audit. The customer shall inform NOTICE and the Competent Authority of any adverse event and the performed actions in that regard. 3.14 The customer shall comply with and follow the update status of documents such as Certificate and Use of Logo Procedure, Certification procedure, Certification regulations and General Condition, etc. Issued at ▇▇▇.▇▇▇▇▇▇.▇▇▇.▇▇ , related directives, standards and all the other legislations. 3.15 The customer is required to pay the fees defined in the service agreement or the fees of specific audits of related standards or directives/ regulations or follow-up audits. 3.16 Upon suspension, withdrawal and cancellation of the certificate, the customer is required to stop the use of certificate and any advertisement material referring to the certificate and shall sends the certificate back to NOTICE in case of withdrawal or cancellation. 3.17 The customer shall comply with national legislation, regulations, standards/common specifications, MDCG documents and MDCG- adopted guidance documents. Companies willing to receive product conformity certificate, are required to comply with all requirements defined in the directive and CE marking requirements. 3.18 After the certification audits, the customer shall inform NOTICE of any changes occurring to internal and external processes. 3.19 Customers file the complaints as described in M.PR.24 Objections and Compliant Evaluation Procedure issued at ▇▇▇.▇▇▇▇▇▇.▇▇▇.▇▇ and in case does not accept the Objection Committee’s decision, can apply to the related legal authority (TURKAK or Ministry of Health of Turkey). In case NOTICE exceeds the time for resolving the complaint, the customer can apply to the related legal authority in the same way. The customer can object to the decision made by NOTICE within one month. 3.20 The customer shall fulfill the general health & safety requirements or other statuary requirements stipulated in 2017/745 Medical Device Regulation and national legislations for product(s) design and production and the conformity assessment requirements according to 2017/745 Medical Device Regulation. 3.21 The customer can use the certificate for the address and scope written on the certificate. In case of violation, the customer accepts the consequences. 3.22 In case of providing others with copies of certification documents (certificate, report, etc.) the customer shall replicate the documents as whole. 3.23 The Customer acknowledges that NOTICE will in no way provide consultancy services to the company in the context of or in

Customer’s liabilities. 3.1 The customer shall give NOTICE documents related to manufacturing, service places, facilities and activities covered by NOTICE’s service scope. All changes occurring in this regard shall be communicated to NOTICE in written. 3.2 The customer sends NOTICE the related documentation and give them access for document examination. 3.3 The customer allows auditors to enter facilities, access system and records as agreed in different stages of services. 3.4 The customer will not conceal from NOTICE any information related to the services. 3.5 In Within the framework of the relevant common specificationCommon Specification, standardStandard, regulations Regulations and other documents published or accepted by MDCG, the customer is obliged to comply with any kind of written or verbal information and instruction taken from NOTICE customer; Responsible for the operation of the management system, product conformity assessment, inspection and testing services. 3.6 The customer whose management system or the product related to As part of the management system certification, the customer is certified shall assign one of the responsible for appointing a personnel for ensuring to ensure the implementation and continuity of the established system, provide auditors’ allowing access to all the required necessary areas in for auditors during working hours, guarantee the provision of all national legislations and ensuring compliance with any existing legal requirements or special requirements apart from specific requests, in addition to the management system standardstandard related to the scope of the document. 3.7 Auditors in the training process, observers or guides can accompany NOTICE in the inspections, audits or unplanned visits carried out in the customer’s site. Observer may be there to observe a member of audit/ inspection team, may be an authorized person of customer, accreditation body or the related ministry. Guides are individuals accompanying the audit team for assistance. Any A guide may be assigned to each member of the audit team can be assigned as guideteam. Guide’s responsibilities may include making communications, arranging meetings, organizing site audit, having site safety regulations applied, witnessing the audit on behalf of the customer, or providing the information requested by the auditor. 3.8 The customer is obliged to declare any kind of verbal or written information to NOTICE personnel, TURKAK representatives or authorities of Ministry of Health of Turkey regarding audit or inspection activities while necessary. 3.9 The customer shall inform NOTICE within duration specified in the Certification Agreement of changes in management system or the certified product related to the management system, the company’s system, or products in the certificate scope after certification and changes affecting system’s structure (address(es), scope, number of workers, number of branches, address of branch(es), etc.) 3.10 The customer shall maintain all the records related to the activities carried out by NOTICE (agreement, report, QMS records, etc.) for the certificate validity period as well as the product in the certificate scope for its shelf lifeperiod. If the periods given for the storage of the relevant standard or regulation/regulation documents and records are longer, this period is valid. 3.11 The customer shall make all the necessary documents for the application available to NOTICE before the inspection and audit. 3.12 NOTICE can may carry out inspections or additional audits in order for a fee to evaluate assess the effect impact of the applied changes made on the system. The client must carry out any significant changes that may occur in the NOTICE documentation system (standard procedures or productrules) within the transition period notified to the client. 3.13 In The customer is obliged to record any objections or complaints received from their own customers or third parties within the scope of the certificate the customer shall record the complaints received from its customers or third parties document provided and shall inform to report them to NOTICE of the complaints inspectors during the audit. The customer shall They must inform NOTICE and together with the Competent Authority of regarding any adverse event notifications and the performed actions in that regardwork carried out. 3.14 The customer shall comply with and follow the update status of documents such as Certificate and Use of Logo Procedure, Certification procedure, Certification regulations and General Condition, etc. Issued at ▇▇▇.▇▇▇▇▇▇.▇▇▇.▇▇ , related directives, standards and all the other legislations. 3.15 The customer is required to pay the fees defined in the service agreement or the fees of specific audits of related standards or directives/ regulations or follow-up audits. 3.16 Upon suspension, withdrawal and cancellation of the certificate, the customer is required to stop the use of certificate and any advertisement material referring to the certificate and shall sends the certificate back to NOTICE in case of withdrawal or cancellation. 3.17 The customer shall comply with national legislation, regulations, standards/common specifications, MDCG documents and MDCG- adopted guidance documents. Companies willing to receive product conformity certificate, are required to comply with all requirements defined in the directive and CE marking requirements. 3.18 After the certification audits, the customer shall inform NOTICE of any changes occurring to internal and external processes. 3.19 Customers file the complaints as described in M.PR.24 Objections and Compliant Evaluation Procedure issued at ▇▇▇.▇▇▇▇▇▇.▇▇▇.▇▇ and in case does not accept the Objection Committee’s decision, can apply to the related legal authority (TURKAK or Ministry of Health of Turkey). In case NOTICE exceeds the time for resolving the complaint, the customer can apply to the related legal authority in the same way. The customer can object to the decision made by NOTICE within one month. 3.20 The customer shall fulfill the general health & safety requirements or other statuary requirements stipulated in 2017/745 Medical Device Regulation and national legislations for product(s) design and production and the conformity assessment requirements according to 2017/745 Medical Device Regulation. 3.21 The customer can use the certificate for the address and scope written on the certificate. In case of violation, the customer accepts the consequences. 3.22 In case of providing others with If the customer provides copies of certification documents (certificatedocuments, reportreports, etc.) the customer shall replicate to others, he/she is obliged to ensure that the documents as wholeare reproduced without compromising their integrity. 3.23 The Customer acknowledges that NOTICE will in no way provide consultancy services to the company in the context of or inin relation to conformity assessment and does not make any requests in this respect.