Understanding EU MDR Article 61(10): A Pathway for Medical Device Manufacturers When Clinical Data is Inappropriate

The European Union Medical Device Regulation (EU MDR 2017/745) introduces rigorous requirements for the clinical evaluation of medical devices to ensure their safety and effectiveness. However, under specific circumstances, Article 61(10) of the MDR offers an alternative pathway for manufacturers to demonstrate compliance with the General Safety and Performance Requirements (GSPR) when clinical data is deemed inappropriate or irrelevant for a particular device. In this article, we will dive deep into the application of Article 61(10), the types of devices that qualify, and the steps manufacturers must take to leverage this provision. 

What is Article 61(10) of the EU MDR? 

Article 61(10) of the EU MDR provides a route for manufacturers to demonstrate that their medical device meets safety and performance standards without clinical data. While clinical evaluation is essential for proving compliance with GSPR, this article applies to devices for which clinical data is not deemed appropriate or necessary. This provision is especially relevant for low-risk devices or those that do not have a direct clinical impact. 

It is important to note that this option is not available for Class III or implantable devices. Instead, it applies to lower-risk devices, where performance can be sufficiently demonstrated through non-clinical data such as mechanical testing, performance evaluations, and other bench testing. 

 

Devices Eligible for Article 61(10) Compliance 

Under Article 61(10), certain types of medical devices are more likely to qualify for non-clinical data to demonstrate compliance. These include: 

• Dental Treatment Units 

• Mouth Spatulas 

• Operating Lights 

• Patient Positioning Systems 

• Stand-alone Software 

• Blood Glucose Meters 

• Wheelchairs and Walking Aids 

These devices typically do not require direct clinical evaluation and may not provide clinical benefits, making clinical data unnecessary. Instead, performance and safety can be proven through non-clinical means such as mechanical tests and risk assessments. 

 

Providing Justification for Using Article 61(10) 

To utilize Article 61(10), manufacturers must justify why clinical data is inappropriate. The justification must be documented in a clinical evaluation report, and key considerations include: 

1. Risk Management

Effective risk management is essential to demonstrate that the device presents minimal risks. Manufacturers must thoroughly document potential risks and hazards associated with the device, and if these risks can be effectively mitigated, this strengthens the case for relying on non-clinical data. 

2. Interaction with the Human Body

Devices that have limited or no direct interaction with the human body are more likely to qualify for Article 61(10). For example, devices like dental treatment units or wheelchairs may fall into this category. However, devices with critical interactions, such as surgical instruments, would require clinical data. 

3. Intended Clinical Performance

If a device has clinical claims that cannot be verified through non-clinical testing, clinical data will still be necessary. For devices with indirect clinical benefits based on their technical performance, manufacturers can support their claims with robust non-clinical data such as mechanical and biocompatibility testing. 

 

Elements of a Clinical Evaluation Report Under Article 61(10) 

Even without clinical data, manufacturers must still prepare a comprehensive clinical evaluation report to support the device’s safety and performance claims. Key components of this report include: 

• Justification for Using Article 61(10): A detailed explanation for why clinical data is not required for the device. 

• Scientific Literature Review: An assessment of scientific literature to confirm that no relevant clinical data has been overlooked. 

• Non-Clinical Data Summary: A thorough analysis of non-clinical data (e.g., performance testing, mechanical testing, and biocompatibility studies) to validate safety and performance. 

• Vigilance and Post-Market Data: Any available legacy data or post-market surveillance that demonstrates the safety and reliability of similar devices. 

• Data Analysis: A clear explanation of how non-clinical data supports the device’s compliance with the GSPR. 

 

Notified Body Evaluation of Article 61(10) Applications 

Notified bodies play a critical role in reviewing the application of Article 61(10). They will assess: 

• The adequacy of the justification provided by the manufacturer for using non-clinical data. 

• The sufficiency of non-clinical evidence in supporting the safety and performance claims. 

• The results of risk management procedures and whether these align with the proposed use of non-clinical data. 

• The device’s interaction with the human body, and whether it necessitates clinical data. 

By thoroughly reviewing these factors, notified bodies ensure that non-clinical data is appropriate for demonstrating compliance with the GSPR. 

 

Conclusion: Leveraging Article 61(10) to Simplify Compliance for Low-Risk Devices 

EU MDR Article 61(10) provides an important alternative for demonstrating compliance for medical devices where clinical data is inappropriate. Manufacturers can rely on non-clinical data such as performance evaluations, mechanical tests, and risk management strategies to show that their devices meet the necessary safety and performance standards. 

It is important to note that while Article 61(10) offers a pathway for low-risk and non-clinical devices, it requires careful documentation and strong justification. By providing detailed non-clinical evidence and a comprehensive clinical evaluation report, manufacturers can successfully navigate the regulatory framework while ensuring patient safety and compliance. 

 Need Help with EU MDR Article 61(10) Compliance? 

At BioBoston Consulting, we specialize in helping medical device manufacturers navigate the complexities of EU MDR compliance. Whether you need assistance in preparing clinical evaluation reports, performing risk management, or evaluating the appropriateness of non-clinical data, our team of experts is here to guide you every step of the way. 

Contact BioBoston Consulting today to ensure your device meets all regulatory requirements, including the provisions of Article 61(10), and gain access to global markets with confidence.