How clinical investigations fit into the clinical evaluation process

When it comes to getting a medical device approved under the Medical Device Regulation (MDR) (EU 2017/745), one of the most critical components is the clinical evaluation process. This is where manufacturers prove that their device is safe and does what it’s supposed to do. But how do you gather the data to support that claim? That’s where clinical investigations come into play.

Clinical evaluation and clinical investigations are deeply connected, but they’re not the same thing. Think of clinical evaluation as the bigger picture — a continuous process of collecting and analyzing clinical data to support the device’s safety and performance. Clinical investigations, on the other hand, are one of the ways to generate that data. Let’s break it down.

What exactly is clinical evaluation?

The clinical evaluation process is an ongoing cycle that starts before a device ever hits the market and continues throughout its entire lifecycle. The goal is to provide sufficient clinical evidence to demonstrate that the device meets the General Safety and Performance Requirements (GSPRs) set by MDR.

Clinical evaluation typically relies on three main sources of data:

• Existing clinical data from literature (on equivalent or similar devices).
• Post-market clinical data (feedback from real-world use after the device is already on the market).
• New clinical data generated through clinical investigations (if existing data isn’t enough).

For low-risk devices or devices that are very similar to already approved ones, manufacturers might be able to base their clinical evaluation mostly on literature reviews and post-market data. However, when there isn’t enough existing data—especially for high-risk devices (Class III, implantables)—clinical investigations become essential.

So, what’s the role of clinical investigations?

Clinical investigations (or clinical trials, as they’re sometimes called) are controlled studies performed on human subjects to assess how a device performs in real-world conditions. Under MDR, they are mandatory for most high-risk devices and any device that doesn’t have sufficient clinical data from other sources.

The purpose of a clinical investigation is to:

• Collect direct clinical evidence on safety and performance.
• Identify potential risks that weren’t obvious in lab testing.
• Confirm long-term effects and usability in real patients.
• Support claims made in the clinical evaluation with solid data.

For example, if you’re developing a new type of implantable heart valve, you won’t find much useful data in literature about similar devices because yours is unique. In this case, you’ll need to conduct a clinical investigation to gather fresh clinical evidence and prove that your device is both safe and effective.

When are clinical investigations required?

Not every device needs a clinical investigation, but MDR is much stricter than the old MDD (Medical Device Directive) when it comes to clinical data requirements. Clinical investigations are generally required when:

• There’s no equivalent device already on the market.
• The device has a completely new design or technology.
• It’s a high-risk device (Class III or some Class IIb devices).
• Existing clinical data isn’t strong enough to meet MDR’s evidence requirements.

On the flip side, if you can demonstrate equivalence with an already approved device and back it up with sufficient clinical data, you might be able to skip a clinical investigation and rely on existing evidence instead.

How clinical investigations feed into the clinical evaluation process

A clinical investigation is not just a one-time event—it’s part of the bigger clinical evaluation cycle. Once you conduct a study, the results get incorporated into the Clinical Evaluation Report (CER), which is reviewed by Notified Bodies as part of the certification process.

But the connection doesn’t stop there. Once the device is on the market, the clinical evaluation process continues through Post-Market Clinical Follow-Up (PMCF). If new risks or performance issues are identified, manufacturers may need to conduct additional clinical investigations to update the clinical evidence.

Putting it all together

To sum it up, clinical evaluation and clinical investigations go hand in hand. Clinical evaluation is the ongoing process of proving your device is safe and effective, and clinical investigations are sometimes necessary to generate the data to support that claim.

If you’re bringing a low-risk device to market and can rely on existing literature and post-market data, you might not need a clinical investigation. But for high-risk or innovative devices, clinical investigations are often unavoidable.

Either way, under MDR, clinical evaluation never stops—you don’t just gather data once and forget about it. You’ll need to keep collecting and updating clinical data throughout the lifecycle of your device, ensuring that it remains safe and effective for patients.

If you’re unsure whether your device needs a clinical investigation, it’s always best to seek regulatory guidance early in the process. That way, you can avoid surprises and ensure you’re on the right track for MDR compliance.

Would you like to explore specific requirements for clinical investigations under MDR in more detail?