TÜV SÜD Danmark ApS MDR Conformity Assessment Procedures

• Pre-application form submitted by potential client
• Pre-application completeness check
• Acceptance / Rejection of Pre-application
• Establish framework agreement and conformity assessment order incl. quotation
• Confirmation of conformity assessment order
• Self-assessment forms and other necessary forms for client to review and fill in

• Signed application to be submitted together with QMS and technical documentation package per agreement in the conformity assessment order. (In case application is submitted beforehand of the QMS and technical documentation, the application is only considered final when the documentation listed in the QMS and technical documentation checklists has been reviewed)
• Administrative Review
• Acceptance / Rejection of Application (If rejected application steps below will not proceed)
• Client submission of QMS and Technical Documentation
• Application complete
• Registration in EUDAMED

(Assessment of the technical documentation is performed prior or parallel to on-site audits)

• The technical documentation + completed checklist submitted by client together with application, will go through a completeness check to ensure all documents are submitted.
• Client will be informed if any documents are missing (if any and will be asked to provide the missing documents. If these are not provided this may lead to a delayed review as the initiation of conformity assessment cannot start or result in non-conformities being raised during the conformity assessment for missing documentation.
• When completeness check has been successfully completed, initiation of conformity assessment activities will commence.
• The submitted technical documentation will be split into a pre-clinical and clinical assessment.
• If non-conformities are identified within the documentation, the client will receive a non-conformity report. We will perform agile reviews with close contact with the client during the review.
• Client addresses non-conformities
• If the client cannot close the non-conformities within 3 rounds of responses, the application will be rejected and the client requested to file a new application.
• Technical documentation assessment report issued.

• The QMS documentation + completed Client QMS Documentation Self-Assessment Evaluation Form submitted by client, will go through a off-site audit process.
• Client will be informed about the output of the process by the Off-site Audit Report. If any non-conformities will be issued, they will be forwarded to the client as a non-conformity report. Based on successful completion of the off-site audit, the auditor will dispatch to the client a plan for the on-site audit.
• On-site audit will be conducted at the client premises. The on-site audit may be expanded to include critical subcontractors and suppliers based on company setup.
• During the closing meeting of the audit, the client will be informed about the non-conformities (if any)
• The client will receive a full audit report containing the non-conformities within 14 working days from the audit. The client shall submit plans for corrections and corrective actions according to specified time frames based on the criticality of the identified nonconformities.

• QMS certificate(s) issued

• Pre-application form submitted by potential client
• Pre-application completeness check
• Pre-application review
• Acceptance / Rejection of Pre-application
• Establish non-binding quotation and framework agreement
• Order confirmation

• Filled in application form from client
• Administrative Review
• Acceptance / Rejection of Application (If rejected application steps below will not proceed)
• Client submission of QMS and Technical Documentation
• Application complete
• Registration in EUDAMED

• The technical documentation + completed checklist submitted by client together with application, will go through a completeness check.
• Client will be informed on missing documentation (if any). If client fails to provide documentation within two request rounds, non-conformities will be issued for the missing documents.
• When completeness check has been successfully completed, initiation of conformity assessment activities will commence.
• The submitted technical documentation will be split into a pre-clinical and clinical assessment.
• If non-conformities are identified within the documentation, the client will receive a non-conformity report
• Client addresses non-conformities
• If non-conformities cannot be closed within 3 rounds of response, the application will be rejected and the client is asked to file a new application.
• Technical documentation assessment report issued.

• The QMS documentation + completed checklist submitted by client together with application, will go through a completeness check.
• Client will be informed on missing documentation (if any). If client fail to provide documentation within two request rounds, non-conformities will be issued for the missing documents.
• When completeness check has been successfully completed, initiation of off-site audit will commence.
• Based on successful completion of the off-site audit, the auditor will dispatch to the client an audit plan for the onsite audit.
• On-Site audit will be conducted at the client premises. Audit may be expanded to include critical subcontractors and suppliers based on company setup.
• During the closing meeting of the audit, the client will receive a list of nonconformities (if any)
• The client will receive a full audit report within 14 days from the audit.
• The client shall submit plans for corrections and corrective actions according to specified time frames based on the criticality of the identified nonconformities.

• Product certificate(s) issued