Common use of Application Review and Agreement Process Clause in Contracts

Application Review and Agreement Process. 1.1.1. Applications for product conformity assessment regarding to the Regulation (EU) 2017/745 concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company must fill in and sign the application forms completely. The documents required in the application form, the QMS documentation and the Technical Documentation must be delivered to SZUTEST Konformitätsbewertungsstelle GmbH along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. 1.1.2. SZUTEST Konformitätsbewertungsstelle GmbH shall initiate the application review process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST Konformitätsbewertungsstelle GmbH may consult to the Federal Institute for Drugs and Medical Devices listed in the xxxxx://xxx.xxxxx.xx web site based on their scope of coverage in Germany or competent authorities of other Member States during the process of application assessment. During the application the company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for the missing parts of the Technical Documentation together with a plan and declaration for completeness. SZUTEST Konformitätsbewertungsstelle GmbH shall take this into consideration. If the application review identifies missing parts for the Technical Documentation, the company shall submit these documents not later than the imposed deadline by SZUTEST Konformitätsbewertungsstelle GmbH. If the required documentation will not be received within maximum 15 days after the imposed date, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the application. 1.1.3. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company must perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical Documentation and Quality Management System Documentation to SZUTEST Konformitätsbewertungsstelle GmbH within maximum 15 days after the imposed date. 1.1.7. As for transfer applications, SZUTEST Konformitätsbewertungsstelle GmbH may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous notified body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body, SZUTEST Konformitätsbewertungsstelle GmbH may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company must deliver the missing documents within maximum 15 days after the imposed date. In the event that the documentation demanded is not provided by the company following the execution of the agreement, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the agreement. 1.1.10. In case of conflict during the applications, the company shall be demanded to provide additional information and an application shall be filed to the Competent Authority in which the company or its authorized representative is placed and request information regarding the resolution of the conflict. In cases where the company has no registered place of business in the European Union and has not yet designated an authorized representative, the matter shall be referred to the competent authority in which the person or organization to be appointed as the authorized representative has its registered place of business. The costs arising from the application shall be paid by the company. 1.1.11. For several devices consultation to the authorities may be necessary. In this case the related expenses shall be covered by the company. The company may not hold SZUTEST Konformitätsbewertungsstelle GmbH for delays arising from the review conducted by the authorities. 1.1.12. Re- certification applications shall be filed, agreements shall be signed and the requirements of the agreements shall be fulfilled at least 12 months earlier than the expiry date of the certificates, If the application date is less than 12 months before the expiry date SZUTEST Konformitätsbewertungsstelle GmbH may refuse the application after the evaluation of the application however if such application is accepted the Company shall accept the deadline limitations for the non-conformity corrections found during the re- certification as well as possible waiting periods for authority consultations.

Application Review and Agreement Process. 1.1.1. Applications for product conformity assessment regarding to the Regulation (EU) 2017/745 concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company must fill in and sign the application forms completely. The documents required in the application form, the QMS documentation and the Technical Documentation form must be delivered to SZUTEST Konformitätsbewertungsstelle GmbH along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. Application shall be made by authorised person of the applicant company. Application forms should be filled out by authorized person of the company. 1.1.2. SZUTEST Konformitätsbewertungsstelle GmbH shall initiate the application review assessment process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST Konformitätsbewertungsstelle GmbH may consult to the Federal Institute for Drugs and Medical Devices listed in the xxxxx://xxx.xxxxx.xx web site based on their scope of coverage in Germany or competent authorities of other Member States during the process of application assessment. During the application the company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for the missing parts of the Technical Documentation together with a plan and declaration for completeness. SZUTEST Konformitätsbewertungsstelle GmbH shall take this into consideration. If the application review identifies missing parts for the Technical Documentation, the company shall submit these documents not later than the imposed deadline by SZUTEST Konformitätsbewertungsstelle GmbH. If the required documentation will not be received within maximum 15 days after the imposed date, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the application. 1.1.3. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company must perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical Documentation and Quality Management System Documentation to SZUTEST Konformitätsbewertungsstelle GmbH within maximum 15 days after the imposed date10 business days. 1.1.7. As for transfer applications, SZUTEST Konformitätsbewertungsstelle GmbH may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous notified body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body, SZUTEST Konformitätsbewertungsstelle GmbH may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company must deliver the missing documents within maximum 15 days after the imposed date10 business days. In the event that the documentation demanded is not provided by the company following the execution of the agreement, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the agreement. 1.1.10. The previously certified customers must notify SZUTEST Konformitätsbewertungsstelle GmbH for any plan for changes about the approved quality management system or systems or to the product-range covered, the approved design of a device, the intended use of or claims made for the device, the approved type of a device, and any substance incorporated in or utilized for the manufacturing of a device and being subject to the specific procedures in accordance with the specific procedures of the Regulation (EU) 2017/745, if any, by means of the change notification form and application form, if applicable. SZUTEST Konformitätsbewertungsstelle GmbH shall ensure that customers submit for prior approval plans for changes as referred to in above and relevant information relating to such changes, assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of (EU) 2017/745 Regulation, and notify the company of its decision. SZUTEST Konformitätsbewertungsstelle GmbH shall determine the actions necessary to be taken and approve or reject the change subsequently. The change may require updating the agreements or collecting additional changes. 1.1.11. In case of conflict during the applications, the company shall be demanded to provide additional information and an application shall be filed to the Competent Authority in which the company or its authorized representative is placed and request information regarding the resolution of the conflict. In cases where the company has no registered place of business in the European Union and has not yet designated an authorized representative, the matter shall be referred to the competent authority in which the person or organization to be appointed as the authorized representative has its registered place of business. The costs arising from the application shall be paid by the company. 1.1.111.1.12. For several devices consultation The application file for products with medicinal product components shall be sent to the authorities may be necessaryMedicinal Products Authority (Federal Institute for Drugs and Medical Devices listed in the xxxxx://xxx.xxxxx.xx web site based on their scope of coverage or the EMA). In this case The costs arising from the related expenses review of the Medicinal Products Authority shall be covered by the company. The company may not hold SZUTEST Konformitätsbewertungsstelle GmbH for delays arising from the review conducted by the authoritiesMedicinal Products Authority. 1.1.121.1.13. Re- certification Re-assessment applications shall be filed, agreements shall be signed and the requirements of the agreements shall be fulfilled at least 12 6 months earlier than the expiry date of the certificates, If the application date is less than 12 6 months before the expiry date SZUTEST Konformitätsbewertungsstelle GmbH may refuse the application after the evaluation of the application however if such application is accepted the Company shall accept the deadline limitations for the non-conformity corrections found during the re- certification as well as possible waiting periods for authority consultationsassessment.

Application Review and Agreement Process. 1.1.1. Applications for product conformity assessment regarding to the Regulation (EU) 2017/745 concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company must fill in and sign the application forms completely. The documents required in the application form, the QMS documentation and the Technical Documentation form must be delivered to SZUTEST Konformitätsbewertungsstelle GmbH along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. Application shall be made by authorised person of the applicant company. Application forms should be filled out by authorized person of the company. 1.1.2. SZUTEST Konformitätsbewertungsstelle GmbH shall initiate the application review process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST Konformitätsbewertungsstelle GmbH may consult to the Federal Institute for Drugs and Medical Devices listed in the xxxxx://xxx.xxxxx.xx web site based on their scope of coverage in Germany or competent authorities of other Member States during the process of application assessment. During the application the company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for the missing parts of the Technical Documentation together with a plan and declaration for completeness. SZUTEST Konformitätsbewertungsstelle GmbH shall take this into consideration. If the application review identifies missing parts for the Technical Documentation, the company shall submit these documents not later than the imposed deadline by SZUTEST Konformitätsbewertungsstelle GmbH. If the required documentation will not be received within maximum 15 days after the imposed date, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the application. 1.1.3. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company must perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical Documentation and Quality Management System Documentation to SZUTEST Konformitätsbewertungsstelle GmbH within maximum 15 days after the imposed date.to 1.1.7. As for transfer applications, SZUTEST Konformitätsbewertungsstelle GmbH may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous notified body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body, SZUTEST Konformitätsbewertungsstelle GmbH may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company must deliver the missing documents within maximum 15 days after the imposed date10 business days. In the event that the documentation demanded is not provided by the company following the execution of the agreement, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the agreement. 1.1.10. In case of conflict during the applications, the company shall be demanded to provide additional information and an application shall be filed to the Competent Authority in which the company or its authorized representative is placed and request information regarding the resolution of the conflict. In cases where the company has no registered place of business in the European Union and has not yet designated an authorized representative, the matter shall be referred to the competent authority in which the person or organization to be appointed as the authorized representative has its registered place of business. The costs arising from the application shall be paid by the company. 1.1.11. For several devices consultation to the authorities may be necessary. In this case the related expenses shall be covered by the company. The company may not hold SZUTEST Konformitätsbewertungsstelle GmbH for delays arising from the review conducted by the authorities. 1.1.12. Re- certification applications shall be filed, agreements shall be signed and the requirements of the agreements shall be fulfilled at least 12 months earlier than the expiry date of the certificates, If the application date is less than 12 months before the expiry date SZUTEST Konformitätsbewertungsstelle GmbH may refuse the application after the evaluation of the application however if such application is accepted the Company shall accept the deadline limitations for the non-conformity corrections found during the re- certification as well as possible waiting periods for authority consultations.

Application Review and Agreement Process. 1.1.1. Applications for product conformity assessment regarding to the Regulation (EU) 2017/745 concerning Medical Devices shall be filed in writing along with an application form. Verbal applications shall not be accepted. The company must fill in and sign the application forms completely. The documents required in the application form, the QMS documentation and the Technical Documentation form must be delivered to SZUTEST Konformitätsbewertungsstelle GmbH along with this form. The company declares that the information it has provided is correct and complete and agrees that any discrepancy may lead to variations in the terms and conditions of the agreement or termination of the agreement by signing the application form. Application shall be made by authorised person of the applicant company. Application forms should be filled out by authorized person of the company. 1.1.2. SZUTEST Konformitätsbewertungsstelle GmbH shall initiate the application review assessment process upon receiving the application documents. It may demand the company to provide additional documents other than those specified in the application form during this process. SZUTEST Konformitätsbewertungsstelle GmbH may consult to the Federal Institute for Drugs and Medical Devices listed in the xxxxx://xxx.xxxxx.xx web site based on their scope of coverage in Germany or competent authorities of other Member States during the process of application assessment. During the application the company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for the missing parts of the Technical Documentation together with a plan and declaration for completeness. SZUTEST Konformitätsbewertungsstelle GmbH shall take this into consideration. If the application review identifies missing parts for the Technical Documentation, the company shall submit these documents not later than the imposed deadline by SZUTEST Konformitätsbewertungsstelle GmbH. If the required documentation will not be received within maximum 15 days after the imposed date, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the application. 1.1.3. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous Notified Body or Certification Body of the company or demand the company to provide the reports and documents issued by that notified body or certification body for transfer applications. 1.1.4. The application assessment may result positively or negatively. In case it is negative, the company shall be duly informed. 1.1.5. In case the application assessment results positively, an agreement shall be signed with the company. 1.1.6. Upon the signature of the agreement, the company must perform the financial obligations provided in the agreement and deliver all the documentation including specifically the Technical Documentation and Quality Management System Documentation to SZUTEST Konformitätsbewertungsstelle GmbH within maximum 15 days after the imposed date.to 1.1.7. As for transfer applications, SZUTEST Konformitätsbewertungsstelle GmbH may demand the company and the previous notified body to execute a transfer agreement with no financial value. 1.1.8. SZUTEST Konformitätsbewertungsstelle GmbH may contact the previous notified body of the company for transfer applications and reject the application of the company according to the information given. If it is not possible to receive information from the previous notified body, SZUTEST Konformitätsbewertungsstelle GmbH may evaluate the application as a new application or else reject it. 1.1.9. After the agreement is executed, the documentation delivered by the company shall be reviewed and missing documents, if any, shall be determined and notified to the company. The company must deliver the missing documents within maximum 15 days after the imposed date10 business days. In the event that the documentation demanded is not provided by the company following the execution of the agreement, SZUTEST Konformitätsbewertungsstelle GmbH may cancel the agreement. 1.1.10. The previously certified customers must notify SZUTEST Konformitätsbewertungsstelle GmbH for any plan for changes about the approved quality management system or systems or to the product-range covered, the approved design of a device, the intended use of or claims made for the device, the approved type of a device, and any substance incorporated in or utilized for the manufacturing of a device and being subject to the specific procedures in accordance with the specific procedures of the Regulation (EU) 2017/745, if any, by means of the change notification form and application form, if applicable. SZUTEST Konformitätsbewertungsstelle GmbH shall ensure that customers submit for prior approval plans for changes as referred to in above and relevant information relating to such changes, assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of (EU) 2017/745 Regulation, and notify the company of its decision. SZUTEST Konformitätsbewertungsstelle GmbH shall determine the actions necessary to be taken and approve or reject the change subsequently. The change may require updating the agreements or collecting additional changes. 1.1.11. In case of conflict during the applications, the company shall be demanded to provide additional information and an application shall be filed to the Competent Authority in which the company or its authorized representative is placed and request information regarding the resolution of the conflict. In cases where the company has no registered place of business in the European Union and has not yet designated an authorized representative, the matter shall be referred to the competent authority in which the person or organization to be appointed as the authorized representative has its registered place of business. The costs arising from the application shall be paid by the company. 1.1.111.1.12. For several devices consultation The application file for products with medicinal product components shall be sent to the authorities may be necessaryMedicinal Products Authority (Federal Institute for Drugs and Medical Devices listed in the xxxxx://xxx.xxxxx.xx web site based on their scope of coverage or the EMA). In this case The costs arising from the related expenses review of the Medicinal Products Authority shall be covered by the company. The company may not hold SZUTEST Konformitätsbewertungsstelle GmbH for delays arising from the review conducted by the authoritiesMedicinal Products Authority. 1.1.121.1.13. Re- certification Re-assessment applications shall be filed, agreements shall be signed and the requirements of the agreements shall be fulfilled at least 12 months earlier than the expiry date of the certificates, If the application date is less than 12 months before the expiry date SZUTEST Konformitätsbewertungsstelle GmbH may refuse the application after the evaluation of the application however if such application is accepted the Company shall accept the deadline limitations for the non-conformity corrections found during the re- certification as well as possible waiting periods for authority consultations.least