Main Purpose of Role
The role of the CV Reviewer is to perform a technical review* of the MDR CV packs to verify data and their content for compliance required by the MDD 93/42 EC; Regulation MDR (EU) 2017/745; Regulation IVDR (EU) 2017/746; ISO13485 Criteria; and by internal SGS procedures for the subsequent review (and preliminary approval) by the Senior CV Reviewer and the final approval by Global Technical Manager MD (Competence).
The following is expected of the CV reviewer:
- To assist the Senior CV Reviewer and the Global Medical Device Technical Manager (Competence) to implement the necessary process intended for MDR CV reviews and following approvals.
- To act within NB 1639 and review MDR CVs in compliance with current procedures, practices and criteria.In particular, to ensure that records and data are maintained to demonstrate appropriate objective evidence of compliance with the Regulatory and SGS requirements.
- To serve as point of contact as part of the MDR CV review's process between the NB 1639 and the Medical Device Auditors, Lead Auditors and Product Assessors ensuring that communications/queries are resolved in a timely fashion.
- To ensure that the required documents, objective evidence and data (concerning workplace experience, education, training, consultancy, etc.) are efficiently collected and presented.
Key Accountabilities:
The CV Reviewer verifies that CV set information is in compliance with the medical device regulations and internal procedures.The CV Reviewer verifies that all main requested technical information (e.g.to support MD codes, etc.) has been addressed and closed out before transferring the CV set for a final CV pack review and assessment.
The CV Reviewer establishes whether the CV pack demonstrates:
- That the CV pack has been completed in accordance with relevant procedures; including a verification of the information provided by SGS auditor/LA/PA in detail.
- That all records of the CV pack and data are maintained to demonstrate appropriate objective evidence.
- That the CV has addressed the requirements related to the medical devices' specific codes.
- That the CV has the full information about relevant and specific standards/normative documents, previous professional experience, etc.
- To perform conformity assessment of personnel (related to NB 1639 activities) for initial, on-going and re-approval CV assessment:
- Review CV content to ensure compliance with MDR/IVDR/ISO13485 requirements
- Review (medical device) codes applied and ensure that the competence level is appropriate for the code
- Review the submitted information re Level 1 Audit and 3 Years' review for Auditor and Lead Auditor roles
- Review the submitted information regarding Mirror Review and also for 3 Years' review for Product Assessor role.
- Compile and update Formal Excel review form for the following roles (for the next stage of the technical review) for Auditor/Lead Auditor/Product Assessor
- Review of updated CVs to add codes
- Alignment of Revision level to ensure all documents are at the correct revision
- Ongoing review of CVs in line with the Competent Authorities guidelines
- Assist Auditors, Lead Auditors and Product Assesso.
