Application of EU MDR Article 61(10) When Clinical Data is Considered Inappropriate
The European Union Medical Device Regulation (EU MDR 2017/745) has introduced more stringent requirements for the clinical evaluation of medical devices to ensure patient safety and device effectiveness. As per Article 61(10) of the MDR, it specifically provides a pathway for manufacturers to demonstrate compliance with the General Safety and Performance Requirements (GSPR) when clinical data is considered inappropriate or irrelevant for certain devices. This blog scrutinizes the fundamental elements of Article 61(10), delineates the categories of data that can demonstrate compliance, and furnishes instances of medical devices that could potentially fall under this regulatory framework.
Regulatory Framework for Clinical Evaluation
Article 2(44) of the Medical Devices Regulation defines clinical evaluation as a “systematic and planned process to generate, collect, analyze, and evaluate clinical data relating to a device on an ongoing basis in order to verify the safety and performance, including clinical benefits, of the device when used in accordance with the manufacturer’s intended purpose.” This process is crucial for proving compliance with the General Safety and Performance Requirements (GSPR) outlined in Annex I of the MDR.
However, there are instances where the use of clinical data is not appropriate, and in such cases, Article 61(10) offers a pathway for manufacturers to demonstrate compliance through non-clinical data. This route is especially relevant for devices that may not provide direct clinical benefits or that involve low-risk usage.
The Scope of Article 61(10)
Article 61(10) specifies the conditions under which clinical evaluation can be conducted without clinical data. This provision is not applicable to Class III or implantable devices, as stated by the phrase “Without prejudice to paragraph 4.” Instead, it applies only to devices in other classifications where clinical data is deemed inappropriate.
For these devices, non-clinical data such as performance evaluations, mechanical tests, and bench testing may be used to demonstrate conformity with safety and performance requirements. However, manufacturers must provide adequate justification for why clinical data is inappropriate, which is a regulatory requirement under Article 61(10).
Device Categories Eligible for Article 61(10)
Certain device categories are more likely to qualify under Article 61(10), such as:
- Mouth spatulas
- Dental treatment units
- Operating lights
- Patient positioning systems
- Stand-alone software
- Blood glucose meters
- Wheelchairs and walking aids
These devices are either low-risk or do not have direct clinical impact, making clinical data unnecessary.
Providing Justification for Article 61(10):
To apply Article 61(10) for a medical device, the manufacturer must provide a thorough and justified explanation in the clinical evaluation report. The following elements are critical in this justification:
a) Risk Management
Effective risk management is a cornerstone of justifying Article 61(10). The manufacturer must clearly document any potential risks associated with the device, including hazards, residual risks, and their potential impact on users. If risks are found to be minimal and can be managed effectively, this strengthens the case for relying on non-clinical data.
b) Interaction with the Human Body
Devices that either do not interact with the human body or have limited interaction (e.g., dental treatment units, wheelchairs) may qualify for Article 61(10). However, for devices with direct and critical interactions (e.g., surgical tools), clinical data might be required.
c) Intended Clinical Performance
If a device under Article 61(10) is claimed to have clinical performance that cannot be assessed through non-clinical means, clinical data will still be required. For devices that offer indirect clinical benefits based on technical performance, non-clinical evidence can be used to justify the claims, but these must be well supported with non-clinical test data.
Elements of a Clinical Evaluation Report Under Article 61(10):
Even when clinical data is not available, a comprehensive clinical evaluation report must still be prepared. This report must be submitted to and reviewed by a notified body. The key components of this report should include:
- Rationale for Using Article 61(10): A detailed justification for the application of Article 61(10) and the reasons clinical data is considered inappropriate.
- Scientific Literature Search: A review of scientific literature to ensure no relevant clinical data has been overlooked and to establish the state of the art for similar devices.
- Non-Clinical Data Summary: A comprehensive analysis of non-clinical evidence (e.g., mechanical testing, biocompatibility testing) that supports the device’s safety and performance.
- Vigilance Data: Information from legacy devices and post-market surveillance data that confirms the device’s safety record.
- Data Analysis: A detailed explanation of how available non-clinical data supports the device’s performance and safety claims.
Evaluation by Notified Bodies:
Notified bodies, as part of the clinical evaluation assessment process, review whether the application of Article 61(10) is appropriate for a particular device. They will assess:
- The adequacy of the justification provided for using non-clinical data.
- Whether the available non-clinical evidence is sufficient to support the safety and performance claims.
- The results of risk management and how they support the application of Article 61(10).
- The device’s interaction with the human body and any potential need for clinical data.
Conclusion:
The pathway outlined in Article 61(10) provides an alternative route for medical devices where clinical data is inappropriate for demonstrating compliance with GSPR. Manufacturers must present a strong, justified case to use this route, providing robust non-clinical data and a thorough analysis in the clinical evaluation report. Article 61(10) is not a waiver of clinical data requirements but a targeted option for low-risk, less complex devices. Properly documented and justified, this approach ensures that devices remain safe and effective without the need for clinical data.
Manufacturers must work closely with notified bodies and ensure that all regulatory requirements are met, including robust risk management and clear non-clinical evidence, to successfully apply Article 61(10). For further information on application of EU MDR Article 61(10), please reach out to MakroCare today!