CER Proposal

1. PREPARED FOR

APPLICANT

ORIGINAL EQUIPMENT MANUFACTURER
OWN BRAND LABELER

Manufacturer Name and Full Address
(To be printed in the CE Certificate)

CONTACT PERSON

APPLICANT
APPLICANT REPRESENTATIVE / CONSULTANT

2. PREPARED BY

NAME

CONTACT NUMBER

DATE

PROPOSAL NUMBER

I3C-CER- -REV:

PROPOSAL VALIDATY

Alsstr. 97, 41063 Mönchengladbach, Germany
1st Floor, No: 221, # 3, 7th Cross, 6th Block, BSK Stage 3, Bengaluru, 560085, India
58, Peregrine Road, Essex, England, IG6 3SZ, UK
JN Pease Pl, Charlotte, North Carolina, 28262,USA
R2202 CT2B, 609 Truong Dinh, Hoang Mai, Hanoi, VN

3. EXECUTIVE SUMMARY
This business proposal and contract were submitted to the respected organization with complete confidence in the MDR article 61 and MEDDEV 2.7.1 Rev 4. Since the scope of work is only limited to CER documentation, we will not be responsible for any major finding by notified Body in the technical documentation. As part of customer service, we develop and maintain the CER documentation in the cloud till the contract period. We only request technical, scientific, and clinical information and real-time PMS data for the smooth development of CER. It is essential that the client team must cooperate in providing accurate information from technical documentation. The client team must cooperate and guide us by reviewing the documents on a weekly basis, and comments whenever required. All customer-provided documents and records (data) will be kept confidential and transferred to the cloud shared folder during the preparation and NB review stage. We implemented ISO 27701:2016 for data security and certified.

3. EXECUTIVE SUMMARY

This business proposal and contract were submitted to the respected organization with complete confidence in the MDR article 61 and MEDDEV 2.7.1 Rev 4. Since the scope of work is only limited to CER documentation, we will not be responsible for any major finding by notified Body in the technical documentation.

As part of customer service, we develop and maintain the CER documentation in the cloud till the contract period. We only request technical, scientific, and clinical information and real-time PMS data for the smooth development of CER. It is essential that the client team must cooperate in providing accurate information from technical documentation. The client team must cooperate and guide us by reviewing the documents on a weekly basis, and comments whenever required.

All customer-provided documents and records (data) will be kept confidential and transferred to the cloud shared folder during the preparation and NB review stage. We implemented ISO 27701:2016 for data security and certified.

4. DEVICE INFORMATION
REGULATION
Number of Devices covered in the proposal
1. Device Common Name / Generic Name
Device Class & GMDN
Intended Use


Models/Variants
Accessories / Consumables
Fee
2. Device Common Name / Generic Name
Device Class & GMDN
Intended Use


Models/Variants
Accessories / Consumables
Fee
3. Device Common Name / Generic Name
Device Class & GMDN
Intended Use


Models/Variants
Accessories / Consumables
Fee
4. Device Common Name / Generic Name
Device Class & GMDN
Intended Use


Models/Variants
Accessories / Consumables
Fee

5. PROJECT FEE

Scope exclusions if any:
Project Fee:
(In Words):

6. PAYMENT SCHEDULE

(With NB Coordination)

Start of project: 40%
Before Notified Body Submission: 30%
Answering to Initial NB comments: 20%
After receipt of draft Certificate: 10%

(Without NB Coordination)

Start of project: 50%
After Literature Search: 20%
Before CER Handover: 30%

All payments to I3CGLOBAL must be made using the tax invoices generated according to the schedules above.

7. PROJECT TIMELINE

In general, we can complete clinical evaluation report documentation covering PMS, PMCF, and PSUR in 3-4 months. To keep the project on track, the manufacturer's collaboration and response speed are crucial.

The notified body will create the Clinical Evaluation Assessment Report and distribute it to an expert panel. Finally, the expert panel makes a decision. The process typically takes more than 7-9 months for class III devices and 4-6 months for other classes.

8. STATEMENT OF WORK

#	REQUIRMENT	SCOPE OF I3CGLOBAL	SCOPE OF MANUFACTURER
I.	The introduction of EU MDR requires the update of the content of the CER. The clinical safety and efficacy need to be proved with proper clinical evidence for all classes of devices. This applies to legacy devices which are already on the market as well as new devices which are to be introduced into the market	The impact assessment of the requirements of the MDR relating to the products to be identified, which includes a review of the device’s updated classifications and the associated regulatory and quality system requirements. This assessment helps in understanding the documentation impact of the EU MDR on the CERs and also determines the further steps to be taken for ensuring their compliance to EU MDR regulation.	Inform I3C all the information related to the device and its components with at most accuracy.
II.	Route / Method	Identify which route to perform the Clinical Evaluation – Literature search + pre-clinical evidence OR Clinical Investigation OR based on Article 61(10) [Clinical data not deemed appropriate]	Provide Clinical Investigation Report (if available), technical file of the device (if available), pre-clinical or bench test reports, RMF, PMSR/PSUR, PMCF study report, User guide/IFU.
STAGE 0 – Scoping & Planning
0.1	Clinical Evaluator	Guidance and drafting of templates for the declaration of Interest.	Identify and appoint a Clinical Evaluator
0.2	Develop Clinical Evaluation Procedure in line with standard requirements. Clinical Evaluation Plan Literature Search Plan Appraisal Plan	Develop procedure and or modify customer supplied procedure(s) Develop the necessary record templates in line with procedure and develop strategies for scoping and activity planning, literature search and appraisal.	Clarify doubts, when necessary. Assign responsibilities. Review and approve.
STAGE 1- Identification of Pertinent Data
1.1	Data Retrieved from the Manufacturer	Develop detailed SOP. Develop Identification of Pertinent Data template Guides manufacturer on pre-clinical and non-clinical studies. Identifies data that can be retrieved from manufacturer and adds data based on that to the template.	Extend necessary support for consultants with pre-clinical data in a systematic way. Provide information of any clinical studies such as Clinical investigations as ISO 14155 or Post-market studies on the device
1.2	Literature Search and Review Report	Develop detailed SOP. Develop relevant Literature search and review report template. Perform a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, GSPR [MDR] and SOTA/SOA, and prepares the literature search report for meeting the requirement of safety and performance of the device. Prepares literature search review report based on the review questions added in Literature search plan.	Review and approve.
STAGE 2 – Appraisal of Pertinent Data
2.1	Demonstration of Equivalence (if applicable)	Develop detailed SOP. Develop Demonstration of Equivalence template based on MDCG guidance. Demonstration of equivalence, if applicable Inform about similar device details obtained from pieces of literature (if any)	Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency) As applicable, a contract must be signed between your company and the manufacturer of the equivalent device if your product is Class III or implantable or must have access to equivalent device data on an on-going basis, if any other classes (if applicable)
2.2	Appraisal of Pertinent Data	Develop detailed SOP. Develop appraisal of pertinent data template Appraises the clinical data collected from the manufacturer as well as that from the literature search based on the criteria set in the Appraisal plan.	Review and approve.
STAGE 3 – Analysis of Clinical Data
3.1	Analysis of the Clinical Data	Develop detailed SOP. Develop analysis of clinical data template Perform qualitative analysis of the clinical data obtained from the literature as well as data retrieved from the manufacturer based on the essential requirements and corresponding GSPRs.	Review and approve.
STAGE 4- Development of CER
4.1(a)	Risk Management and IFU/User guide/User Manual	Develop or modifies the Risk Management Procedure and templates based on EN ISO 14971, if required. Reviews, guides, and makes necessary modifications on manufacturer’s RMF. Benefit-Risk Determination and Conclusion review and suggestion Suggests changes in the IFU/User guide based on the inputs from the CER, RMF, PMS, PSUR and PMCF	Share the existing Risk procedure and RMF. Modify RMF/IFU based on the outputs of CER. Review and approve.
4.1(b)	Post Market Surveillance and Vigilance Reporting (Active, Non-active, Implantable and Software Devices)	Develop or modifies the PMS procedure. Develop templates such PMS plan, Data Analysis Plan & Report, Sales Data, Customer Feedback, User Feedback and Review of PMS Plan, as needed. Support in the PMS planning. Reviews the collected data based on the PMS sources. Preparation of PMS report for Class I device Drafts or guides in the preparation of Vigilance procedure and associated templates	Extend necessary support by following PMS plan scheduled for the PMS period. Collect PMS data based on the PMS sources chosen – Organize Sales History and Sales volume data, Customer and User Feedback Review and approval of PMS plan, Data analysis plan & report and the evidence Review and approval of PMSR and reports associated with Vigilance.
4.1(c)	Post Market Clinical Follow-up (Active, Non-active, Implantable and Software Devices)	Prepares procedure for PMCF, if required. Prepares PMCF Plan & Evaluation Report templates based on the MDCG guidance. Supports in selection of device for PMCF. Prepares PMCF plan. Guides to choose the suitable PMCF methods (general and specific) as per the characteristics and type of medical devices. Verifies the findings and the results based on the PMCF methods chosen Compiles the PMCF evaluation report.	Extend necessary support by following the PMCF plan by following the PMCF period selected in line with the PMS. Identify methods of PMCF based consultant’s inputs. Perform the general and specific PMCF activities such as Surveys and Clinical Investigation (If applicable)- to be outsourced to a third-party agency. Review and approve PMCF plan, other evidence and PMCF Evaluation Report
4.1(d)	Periodic Safety Update Report (Active, Non-active, Implantable and Software Devices) (Not applicable for Class I devices)	Develop PSUR template based on MDCG guidance, as needed. Reviews the collected data and evidence based on the PMS sources. Preparation of PSUR for risk class IIa and above	Extend necessary support by following PMS plan scheduled for the PMS period. Collect PMS data based on the PMS sources chosen – Organize Sales History and Sales volume data, Customer and User Feedback or any other relevant information requested. Review and approve the summarized evidence of PMS data in the PSUR.
4.1	Clinical Evaluation Report	Develop detailed SOP. Develop CER template. Adds information on the CER template based on the summary of inputs from the clinical data provided by the manufacturer and/or the literature or from the Clinical investigation report from stage 1 to stage 3 meeting the GSPRs.	Review and approve CER by the assigned Clinical Evaluator(s).
STAGE 5 - Notified Body Submission
5.1	Technical Documentation Submission	-	Attach CER, PMS, PMCF, and PSUR in the respective sections of the Technical Documentation
5.2	TD Review	Respond to NB queries. Update the file with additional documents/reports if required. Control the revision Number.	Provide technical inputs to I3C team.

9. GENERAL TERMS OF BUSINESS
9.1 NON-DISCLOSURE AGREEMENT. All Confidential information statements and information of any kind given by the applicant will be treated with the highest secrecy and confidence. Without the applicant's specific written approval, we will not divulge such confidential information to any third party. 9.2 MODIFICATION. No modification, termination, or attempted waiver of this agreement, or any component of it, shall be valid unless it is in writing and signed by the party seeking to enforce it. 9.3 NO GUARANTEE. We cannot guarantee a favourable outcome as a consulting organisation. We will constantly rely on our technical ability and past project completion expertise to properly execute the project. 9.4 NOTIFIED BODY REVIEW FEE. CER is included in the technical documentation and the Notified Body's review a maximum of two times. Additional reviews will be charged in line with the terms of the agreed contract. We cannot promise that CER will be accepted in the preliminary rounds, but it will be approved by NB in the concurrent reviews. We shall not be participating in the decision-making process as a consulting business. The NB will make the ultimate decision. 9.5 NON AVAILABILITY OF TECHNICAL INFORMATION. On request, the legal manufacturer / own brand owner / original equipment manufacturer must produce documents and records to consultants in accordance with the request and guidance. All submitted items must, if possible, be double-checked for accuracy and truth. 9.6 SURPRISE EXPENSES. When there is a lack of equivalent device data, market data, and clinical data, Post Market Clinical Follow-up data is essential. Such data generated from clinical investigation or retrospective study is required. We are not directly involved in the investigation or collection of retrospective data collection. 9.7 DOCUMENT SECURITY AND PROJECT CONTACTS. The CER document is being handled, prepared, reviewed, and protected at the central depository located in Bangalore, India. The project-related first-line point of contact is the team lead. The guidance and technical documentation will be taken up by technical consultants. If you feel there is an unresolved issue or a matter that requires additional attention, you should contact the project head who has signed clause 10 of this proposal. 9.8 NO REFUND. If a discrepancy in clause 4 is detected after project beginning, payments will not be refunded. 9.9 CONSULTANT(S) VISIT MANUFACTURER LOCATION. Most of the time, a consultant doesn't need to go to the manufacturer's facility. If any unresolved concerns, we may send a member to your location to address them. Based on the availability our experts travel from Chicago, Charlotte, Bangalore, Düsseldorf, and London. The manufacturer is required to make travel and accommodation arrangements. 9.10 PROJECT DELAY PENALTY. We intend to finish the CER documentation in 3-4 months. We have put in place a strong mechanism for tracking progress on a weekly basis, which we will communicate to all stakeholders every Friday. I3CGLOBAL is committed and promises to pay $50 per day for any delay over 150 days if the CER documentation is not completed. For a successful outcome/on-time completion, the technical team from the client/manufacturer must coordinate and cooperate with actual facts and accurate information regarding devices via email in response to each query/question presented by consultant team members. As a result, we request that the manufacturer team adhere to the same compensation payment of $50 per day for any delay caused by them beyond 150 days.

10. PROPOSAL REVIEW

Name	:	Soio George
Designation	:	Project Head
Email	:	sg@i3cglobal.com
Date	:

I read, reviewed, and confirmed that the information is accurate to the best of my knowledge. I appreciate the opportunity to present our proposal to you, and I look forward to working with you.

I accept

11. PROPOSAL APPROVAL

Name	:
Designation	:
Email	:
Date	:

I acknowledge that I have read and understand the working pattern, scope of both parties, risk involved, and potential variations in project assumptions and timetables, and I now accept them. I3CGLOBAL is now requested to submit an advance payment invoice so that the project can begin as soon as possible.

I accept