Changing the Intended Purpose of an IVD Medical Device in the EU

The medical device industry in the European Union is a dynamic field, governed by stringent regulations to ensure safety, quality, and efficacy. In Vitro Diagnostic (IVD) devices are a subset of medical devices that are designed to perform tests on samples taken from the human body. Earlier QRcompliance published a blog about understanding the concept of the Intended Purpose in the IVDR (click to read this blog). When manufacturers or suppliers wish to change the intended purpose of an IVD, it’s a serious decision that requires careful consideration and compliance with regulatory requirements.

Why Change the Intended Purpose?
There can be various reasons a manufacturer might wish to change the intended purpose of an IVD medical device:
Technological advancements: As technology evolves, new applications for existing devices can emerge.
Clinical findings: Continuous research can reveal new clinical applications for an existing IVD device.
Market demand: Recognizing a new market need can be a trigger for expanding or refining the use of an existing device.

Regulatory Implications
When changing the intended purpose of an IVD:
Reclassification might be necessary: The IVDR (Regulation (EU) 2017/746) classifies IVD medical devices based on the associated risk. A change in intended purpose might shift the device to a higher or lower risk class.
Clinical evidence: Updated clinical data might be required to support the new intended purpose.
Technical documentation: Documentation, including the device’s design, manufacturing process, risk assessment, and clinical evaluation, might need revision.
Notified Body involvement: Higher-risk devices will require a thorough review by a Notified Body.

The Steps to Change
Manufacturers looking to change the intended purpose of an IVD should consider the following steps:
1. Risk assessment: Understand the implications of the change in terms of safety and efficacy.
2. Review technical documentation: Modify as necessary to support the new purpose.
3. Gather new clinical evidence: This can be from new studies, literature reviews, or both.
4. Engage with a Notified Body: If required, seek a review of the changes and get approval.
5. Update labeling and instructions: Ensure users understand the new purpose and any new instructions or precautions.
6. Post-market surveillance: Continue monitoring the device’s performance in its new role.

Challenges and Considerations
Regulatory scrutiny: A change in intended purpose will likely draw increased attention from regulatory authorities.
Post-market performance: The manufacturer must ensure that the device continues to perform safely and effectively after the change.
Stakeholder communication: Clinicians, lab technicians, and other stakeholders should be informed and educated about the change.

Changing the intended purpose of an IVD medical device isn’t just about recognizing a new potential use. It’s a complex process that requires careful planning, documentation, and interaction with regulatory bodies. Manufacturers must always prioritize patient safety and ensure their devices meet the high standards set by the EU’s regulatory framework.

If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.

Leave A Comment