Assessment Process

Initial screening of report form

Upon receipt of a completed Change Report Form, WHO will review the report to determine the actions required to assess the change. The report form and documentation (including project plan if appropriate) will be screened for completeness. This screening does not take into consideration the technical appropriateness of all the information provided within the change report. If the provided documentation is incomplete, the manufacturer will be informed and requested to provide supplements within a specific time period set by WHO. The manufacturer will be given one opportunity to provide this before start of review of the Report Form.

Review of report form

Depending on the type of change proposed, a Report Form will undergo either an an “administrative review”, a “technical review”, or an “abbreviated review” that considers in addition the results of a stringent assessment performed by a national regulatory authority (NRA). Stringent assessment applies to the following regulatory assessments:

  • CE
  • List A, Annex II, US Food and Drug Administration
  • pre-market approval or biologics license application, Health Canada
  • Class IV, Therapeutic Goods Administration, Australia
  • Class 4, Japan, Minister’s approval.

Technical review

A technical review is performed if the proposed change is not considered “administrative” or was not previously stringently assessed by an NRA. A technical review is performed if the change:

  • is likely to affect the quality, safety and/or performance of the IVD or
  • the change introduces new hazards that have not been previously addressed, could adversely affect risks associated with existing hazards, or could alter the presentation of existing or new risks to the user of the IVD.

Technical reviews are performed as described in Overview of the prequalification of in vitro diagnostics assessment. Manufacturers are given one opportunity to address any deficiencies identifieed in the submitted documentation and/or data. If the submitted documentation supporting the change does not meet WHO prequalification requirements or the requested information is not provided by the manufacturer within the specified time period, WHO will reject the change.

Abbreviated review

If the manufacturer can provide proof that the proposed change has been stringently assessed and accepted by an NRA, then WHO will perform an Abbreviated Review, taking into account the
conclusion of the NRA when making its own informed decision as to whether to acceptor reject the change.

Outcome of change assessment

WHO will inform the manufacturer in writing of the outcome of its assessment of the change. The manufacturer will also be notified if WHO deems (based on the nature of the change and its potential impact on the quality, safety and/or performance of the product), that an inspection of the manufacturing site(s) and/or performance evalution is also required. WHO's decisoin to inspect the manufacturing site(s) and/or to carry out performance evaluation will be based on the nature of the change and its potential impact on the quality, safety and/or performance.

Once WHO is satisfied that the prequalification change assessment of a product is complete, and provided that the overall findings demonstrate, as determined by WHO, that the product continues to meet all WHO prequalification requirements, the WHO list of prequalified IVDs will be updated, as necessary, to reflect the relevant change accepted by WHO. If the submitted documentation supporting the change does not meet WHO prequalification requirements or if all the requested information is not provided by the manufacturer within the specified deadline, WHO will reject the change. The impact of such a decision on the prequalification status of the prequalified IVD will be communicated to the manufacturer in writing by WHO.