Description: All IVDs must have a medical purpose, but notified bodies are seeing that most intended purpose statements are noncompliant under IVDR. Although the requirement for an intended purpose statement was included under IVDD, most products did not fall under notified body review, so it often fell through the cracks. Many manufacturers that were previously able to self-certify must now submit to notified body review under IVDR. The IVDR requirements are also much more specific. This is leaving many manufacturers struggling to create compliant intended purpose statements for products that are already on the market.
The intended purpose of an IVD must be specific and match the actual clinical evidence presented. However, changing the intended purpose statement for IVDR compliance has the potential to impact registrations around the world, creating a ripple effect of business ramifications. Considerations for the intended purpose statement to be compliant while also serving the business strategy include:
Does the statement meet the definition of an IVD under IVDR?
Is the statement consistent with the classification of the device under the IVDR and thus impacting the entirety of the technical documentation?
Is there sufficient clinical evidence and performance data to support the statement?
Does the statement need to be adjusted following the outcome of post-market surveillance activities (e.g., on performance and how it is used)?
Will gathering additional data cost more than it's worth to market the product?
Is the statement narrow enough for regulators to accept it given the clinical evidence?
Is the statement flexible enough for payers and providers?
In this session, industry subject matter experts and NB representatives will faciltate a discussion on developing compliant intended purpose statements while minimizing the impact on the business.
Learning Objectives:
Determine if their intended purpose statements are adequate
Implement a strategy for creating compliant intended purpose statements
Understand and educate their team on the most common pitfalls and solutions around developing an IVD intended purpose statement