Prequalification of in vitro diagnostics - Technical Update 24 November 2015
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1 Prequalification of in vitro diagnostics - Technical Update 24 November 2015 Copenhagen, Denmark November
2 Changes assessment Copenhagen, Denmark November
3 Changes to a Prequalified IVD > Guidance for manufacturers for reporting changes to a prequalified IVD: changes to the prequalified product or the manufacturing process changes to the Quality Management System (QMS) and/or other reportable administrative changes Copenhagen, Denmark November
4 Current classification of changes Copenhagen, Denmark November
5 Updated guidance on how to report changes > New classification of changes: Changes are defined either as reportable or non-reportable All substantial changes and certain administrative changes associated with a prequalified IVD are considered as reportable changes These must be reported via submission of the WHO document PQDx_119 Change Report Form for a WHO Prequalified In Vitro Diagnostic Copenhagen, Denmark November
6 Reportable changes > A reportable change is one that is demonstrated, through risk analysis, to have a potential impact on the quality, safety and/or performance of a prequalified IVD > A reportable change may: introduce a risk to the patient not previously identified change the probability of existing hazards occurring alter the presentation of existing or new risks to the user (this can involve labelling changes or new indications for use) Copenhagen, Denmark November
7 Changes requiring a new prequalification application In some cases, changes are of such a magnitude that a new application to prequalification is required. This will occur where it is deemed that the changes have resulted in a product or application information of substantial difference to that which existed at the time of prequalification The combination of several changes can also result in the need for a new prequalification application. Manufacturers should seek advice from WHO when planning to introduce several changes at the same time Copenhagen, Denmark November
8 Non-reportable changes Rewording or expanding for clarification Translating from one language to another Correcting typographical errors Replacing (or complementing) written text by internationally recognized hazard symbols Minor QMS changes such as increased post-market surveillance activity or regular updates of QMS procedures (such as control of documents, management review, etc.) Copenhagen, Denmark November
9 Determining the impact of a change Cause of the change! Actions taken related to concerns arising from post market surveillance, including adverse events, recalls or complaints Development of state of the art Changes to a manufacturing process, facility or equipment Changes to the design or composition of the prequalified IVD Changes to the organization of the manufacturer Changes to the intended use and/or test procedure Changes necessitating new clinical and/or analytical data that raise new issues of safety and performance Copenhagen, Denmark November
10 Determining the impact of a change Impact of the change! Introduces new hazards that have not been previously addressed Adversely affects the risk associated with existing hazards Alters the details of any of the information submitted for prequalification (related to dossier, manufacturing site(s) inspection, or laboratory evaluation), such as the intended use and/or compliance with the Essential Principles Affects the continued compliance of the QMS with the relevant standards Copenhagen, Denmark November
11 Process for assessing and reporting a change Copenhagen, Denmark November
12 Process for reporting a change Reporting to WHO: Let us know in advance! Assessment of submitted PQDx Change Report Forms and documentation: Information undergoes full technical review Outcome of assessment of the change report: Outcome of the assessment is communicated to the manufacturer and where a change is accepted by WHO, the manufacturer can implement the change Copenhagen, Denmark November
13 Useful resources ISO 14971:2007. Medical IVDs Application of risk management to medical IVDs. International Organization for Standardization; Geneva, Switzerland: 2007 GHTF/SG1/N41R9:2005 Essential Principles of Safety and Performance of Medical Devices. Global Harmonization Task Force (GHTF) Steering Committee; 2005 NBOG BPG Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System. Notified Body Operations Group, Bonn, Germany; 2014 CDRH: Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1). Center for Biologics Evaluation and Research, MD, USA; 1997 CDRH: Guidance for Industry and FDA Staff. Modifications to Devices Subject to Premarket Approval (PMA) The PMA supplement decision-making process. Center for Biologics Evaluation and Research, MD, USA; 2008 Health Canada: Guidance for the Interpretation of Significant Change of a Medical Device. Health Products and Food Branch, Ottawa, Ontario; 2011 Copenhagen, Denmark November
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