Module 17 2024

05/12/2024

Implementation of UA’s by Notified Bodies

• Two critical Processes must be reviewed at every UA. There are no exceptions, even for small virtual or software companies. • The two auditors are generally split between a device expert (e.g., Product assessor level) in the specific device chosen for the UA and an auditor approved for the QMS aspects of the device. Generic QMS auditors are not acceptable. If sterilization is one of the critical processes reviewed, one of the auditors must also be approved for the relevant sterilization process. • Device selection is generally based on the highest classifications of devices covered or a lower risk device is there are known vigilance issues

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Implementation of UA’s by Notified Bodies

• CARs raised at UAs are treated the same as CARs raised at scheduled audits e.g., 3 months to close Major CARs. Minor CARs to be reviewed at the next scheduled audit. • Remit of UAs is only MDR/IVDR, CARs cannot be raised on other issues (e.g., ISO13485 areas) or Directives. • Major CARs do not automatically require suspension of CE Certification. The immediate suspension is only due to major safety concerns or refusal to allow entry to the site (a major issue with sub-contractors/suppliers ~ hence the need for formal contracts to allow UAs to take place).

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