The IVD Directive and borderline products

For manufacturers, knowing whether their product is a “medical device” or “an in vitro diagnostic medical device” is crucial but not always straightforward. Choosing the correct regulation can sometimes be challenging when a device can potentially be classified under more than one regulation. Products that fall into this category are commonly called “Borderline” products. The borderlines between each regulatory scheme and directive lie in the definitions and scope statements for each regulation or directive. Some borderline products that could reasonably fall under one regulation don’t because they are specifically excluded from that regulation’s scope. Manufacturers can look at the different properties of their products, starting with their primary intended use and mode of action, when faced with a borderline “situation”. Determining the correct regulatory path becomes crucial for them as it can lead to higher costs and a hazier market access path.

In this webinar, you will learn about:
• The key definitions within the MDD and IVDD
• The clauses required to be fulfilled for IVD devices
• Scenarios for exclusion from the IVDD
• Specific examples of borderline IVD devices
• Guidance documents