Intended purpose - the cornerstone of medical device regulation
by Clea Barton and Jazmin McCalla-Bedward on 2 Apr 2025
Reading time: 2 minutes
Ever wondered what truly drives the regulatory pathway for a medical device? It all boils down to one crucial element: the intended purpose. We interviewed regulatory expert Jazmin McCalla-Bedward who shed light on why this concept is so pivotal and how it impacts every stage of a device's lifecycle.
Intended purpose - what should be included?
The definition of ‘intended purpose’ according to the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) is ‘the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation’.
The intended purpose should contain (if applicable):
- a description of your device
- the medical purpose
- intended disease or condition to be addressed
- target patient population
- who will be using the device, patient or healthcare professional
- the environment the device will be used in.
Why intended purpose matters
Imagine trying to navigate a complex maze without a map. That's what medical device regulation would be without a clearly defined intended purpose. It's the foundation upon which everything else is built.
"It's important because it can help determine the classification of a medical device or an IVD," Jazmin explained. "It sets the pace for the varying levels of scrutiny from a regulatory point of view."
Essentially, the intended purpose dictates the specific requirements of the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). This includes everything from clinical evaluations and investigations to postmarket surveillance and conformity assessment procedures.
Ensuring safety and efficacy
A well-defined intended purpose isn't just about ticking boxes, it's about safeguarding patient safety. Without it, you risk:
- Lack of efficacy: Especially critical for in vitro diagnostic devices (IVD’s).
- Safety concerns: Potential for adverse events.
- Misapplication: Users applying the device incorrectly.
"Intended purpose provides clarity on how the device should be used, by whom and for what condition" Jazmin emphasised. This clarity is essential for preventing misuse and ensuring the device performs as expected.
Intended purpose and postmarket surveillance
The intended purpose doesn't just guide premarket activities, it plays a vital role in postmarket surveillance.
"Indended Purpose will indicate how the device performs in the real world as well as how it should be monitored for adverse events" Jazmin stated.
By defining the scope of potential adverse events, manufacturers can effectively categorise and investigate any issues that arise. This helps distinguish between genuine device malfunctions, user errors, and off-label use.
The dynamic nature of intended purpose
The intended purpose isn't always static. New research and developments can lead to expansions in a device's application. When this happens, manufacturers (people inventing the device / responsible for the device) must update their regulatory status, labelling and potentially conduct additional assessments.
The consequences of ambiguity
Inconsistent intended purpose across technical documentation can result in non-conformities, impacting a device's compliance. This can manifest as failure to meet applicable standards and inadequate testing.
Key takeaways:
- The intended purpose is the bedrock of medical device regulation.
- It dictates regulatory requirements, ensures safety and guides post market surveillance.
- Inconsistency can lead to non-conformities.
Understanding the intended purpose is crucial for anyone involved in the medical device industry. It's the compass that guides manufacturers through the complex regulatory landscape, ultimately ensuring patient safety and device efficacy.