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The Clinical Evaluation Report (CER) is often described as the “beating heart of the Technical Documentation” under the European Union (EU) 2017/745 Medical Devices Regulation (MDR). While most devices require a robust set of clinical data to prove safety and performance, there is a specific regulatory pathway—Article 61(10)—that allows manufacturers to rely solely on technical and preclinical evidence.
However, this is not a “shortcut” or an easy escape from clinical scrutiny. It is a scientifically justified pathway that requires a meticulous and logical rationale. In this blog post, we explore the core parameters required to successfully navigate Article 61(10).
What is Article 61(10)?
Under Article 61(10) of the MDR, a clinical evaluation may rely exclusively on technical and preclinical data when the demonstration of conformity based on clinical data is not deemed appropriate. On the MDCG 2020-6 ranking scale, the sufficient level of clinical evidence for this route is categorized from Rank 10 to Rank 12.
Crucially, this approach is not acceptable for Class III or implantable devices, which inherently require clinical data.
Stratification and the Importance of Consistency
Even when following Article 61(10), the CER must remain thorough. It is essential to maintain consistency of information between the CER, the Technical Documentation, and the Instructions for Use (IFU). Furthermore, performing a stratification of data—even if non-clinical—helps the Notified Body see that you have methodically evaluated all device variants and characteristics.
The Three Pillars of Justification
To follow the Article 61(10) route, manufacturers must build a justification based on three core parameters, assessed both individually and collectively:
Risk Management Outcomes:
A strong justification begins with showing that the device’s hazards are technical in nature, well-understood, and adequately controlled through design and manufacturing.
- Low Residual Risk: You must demonstrate that residual risks are predictable and acceptable based on preclinical testing.
- No Clinical Monitoring: There should be no residual risks that require confirmation through clinical investigations or post-market clinical monitoring.
Interaction Between the Device and the Human Body
The nature and duration of how the device interacts with the patient are decisive.
- Contact Type: Devices with no patient contact or limited/transient contact are the primary candidates for this route.
- Red Flags: Devices with direct contact with blood, the central nervous system, or other critical tissues generally do not qualify, as they are typically Class III.
- Expert Tip: Avoid generic phrases like “no clinical impact expected.” Instead, provide a scientific rationale supported by material characterization or biocompatibility testing.
Intended Performance and Manufacturer Claims
This parameter focuses on whether your claims are technical or clinical.
- Technical Verification: All claimed benefits must be objective and verifiable via bench testing, laboratory studies, or other preclinical methods.
- No Clinical Benefit Claims: If your labeling suggests improved patient outcomes, reduced pain, or decreased complication rates, Article 61(10) is likely no longer appropriate.
Looking Ahead: Future Perspectives
The regulatory landscape continues to evolve. A 2025 proposal to amend the MDR suggests a broader acceptance of non-clinical data sources. This includes the possibility of using bench testing, in silico testing, and computer modeling to demonstrate safety and performance when traditional clinical data is not appropriate, provided the approach is adequately justified within the risk management framework.
Conclusion
Article 61(10) is a vital tool for manufacturers of lower-risk devices where clinical testing may not be the most appropriate way to prove safety. By focusing on a robust technical rationale, clear risk management, and strictly technical claims, manufacturers can meet MDR requirements efficiently while ensuring device safety.