Complying with the European Medical Device Regulation (MDR) might seem like a tough mountain to climb. The requirements are strict, the processes are complex, and there’s no room for mistakes. But don’t worry — we’re here to break it all down step by step.
In this article, we’ll explain:
- What complying with the MDR means when managing clinical data.
- Why the ISO 14155 is your best guide (not your enemy).
- How a validated EDC system can simplify compliance and save you time.
Ready? Let’s dive in.
The Challenge of the MDR: Clinical Data at the Core
If you’re developing a medical device, you already know that MDR compliance isn’t optional. But here’s a key detail many overlook: it all revolves around clinical data.
Clinical data is the backbone of clinical evaluation. It helps you prove that your device:
- Is safe.
- Works as intended.
- Provides a clear and measurable clinical benefit.
Here’s the tricky part: capturing, managing, and safeguarding that data without errors. If something goes wrong, your notified body will let you know (and not in a pleasant way). So, how can you ensure everything is in order?
ISO 14155: Your Guide, Not an Obstacle
The ISO 14155 is the international standard for good clinical practices in medical device clinical investigations. Think of it as the rulebook that tells you exactly how to handle clinical data to meet regulatory requirements.
Key Requirements of ISO 14155
If you’re using an electronic data capture (EDC) system, here’s what ISO 14155 expects from you:
- Validate your tools:
Your system must be documented, tested, and equipped with security measures and recovery plans. - Make it traceable:
Every data change must be logged in an audit trail. - Protect the data:
Only authorized personnel can access it, and every access must be trackable. - Enable monitoring:
The data must be easy to review and analyze.
Meeting these requirements isn’t just mandatory—it’s essential to avoid major issues with notified bodies. Want to know how to make it easier? Keep reading.
What Happens If You Don’t Comply?
Let’s be clear: failing to comply with these regulations can have serious consequences, such as:
- Delays in obtaining CE marking.
- Additional costs for audits or corrections.
- In some cases, being unable to market your device.
But the good news is, avoiding these problems is easier than you might think—if you have the right tools.
How Can ShareCRF Help?
At ShareCRF, we understand how complicated regulatory compliance can be. That’s why we’ve developed a solution that does more than capture clinical data — it helps you comply with international regulations.
What ShareCRF Offers You
- Compliance from Day 1:
Our system is validated according to ISO 14155, GCP, 21 CFR Part 11, and Annex 11. - Full Traceability:
Every data entry, change, and access is logged and auditable. - Efficient Monitoring:
Review real-time data to ensure quality and resolve issues quickly. - Guaranteed Security:
Advanced access controls and protection against unauthorized access. - Flexibility:
Designed for clinical investigations of any size or complexity.
With ShareCRF, you’re not just capturing data — you’re building trust.
Why Clinical Data is the Key to Your Success
Complying with the MDR isn’t just a legal requirement; it’s an opportunity to stand out in the market. A strong clinical data management process not only helps you obtain CE marking but also:
- Strengthens your credibility with clients and regulators.
- Speeds up your processes and reduces approval times.
- Positions you as a manufacturer that prioritizes quality and safety.
In the end, it’s not just about compliance. It’s about taking your product to market with confidence.
Ready to Simplify Regulatory Compliance?
Complying with the MDR and ISO 14155 doesn’t have to be complicated. With a validated EDC system like ShareCRF, you can manage your clinical data efficiently, securely, and in full alignment with international regulations.
Want to see it in action? Request a free demo and discover how we can turn regulatory compliance into a clear and manageable process.
