Initial conformity assessment - RISE MNB
Process for initial conformity assessment for medical devices under the MDR.
Planning
RISE MNB initiates a conformity assessment by planning the activities of auditing and technical documentation assessment.
Audit stage 1
Audit stage 1 is performed by the lead auditor to ensure that the quality management system is complete as applied and as required by the MDR.
Assessment of technical documentation
Technical documentation, including clinical evaluation, is requested and assessed by product reviewers and clinical experts to ensure that the documentation meets the applicable MDR requirements. The initial assessment of the technical documentation must be completed before audit stage 2 is carried out.
Audit stage 2
Audit stage 2 is performed by the lead auditor at the manufacturer’s premises to determine that the manufacturer’s quality management system complies with the applicable MDR requirements.
Reporting, decision, and certificate
The results of the audit carried out, and any non-conformities from the audit or the technical documentation, are presented in reports. The manufacturer responds to any non-conformities by providing a root cause analysis, corrective actions, and corrections. Members of the assignment team manage and assess the responses received and communicate with the manufacturer.
RISE MNB then conducts a final review of the assignment, including the reports and actions. After the final review is approved, a decision on certification is taken.
If the quality management system and the product comply with the applicable MDR requirements, RISE MNB issues a certificate. The MDR certificate is valid for 5 years, provided that all conditions for certification are being met.
CE marking for medical devices
The holder of a valid MDR certificate issued by RISE MNB may use RISE MNB’s ID number as the notified body, together with the CE mark on the products covered by the certificate.
Rules for using RISE MNB certificates and marks (pdf, 91.1 KB)