Clinical evaluation for class I medical devices: process, challenges, and examples

Introduction

Clinical evaluation is a fundamental requirement for medical devices under the medical device regulation (MDR) (EU) 2017/745, ensuring that all devices placed on the market meet safety and performance standards. For class I devices, which are considered low risk, the clinical evaluation process is streamlined compared to higher-risk classifications, but it remains an essential regulatory step. This article explores the clinical evaluation process for class I medical devices, its challenges, and examples, including adhesive plasters.

Clinical evaluation requirements under MDR

MDR requires manufacturers of all medical devices to conduct a clinical evaluation, regardless of risk class. Clinical evaluation for class I devices follows the same structured approach as higher-risk devices but is often less complex due to the well-established nature of many class I products. The key steps include:

• Literature review – Instead of conducting clinical investigations, manufacturers typically rely on existing scientific literature, clinical data from similar devices, and post-market data to demonstrate conformity with general safety and performance requirements (GSPRs).
• Equivalence justification – If the device is similar to existing, well-established products, manufacturers may demonstrate equivalence with those devices and reference their clinical data.
• Post-market surveillance (PMS) and PMCF – Manufacturers must continue to collect and evaluate clinical data through post-market surveillance (PMS), including post-market clinical follow-up (PMCF) when necessary.
• Risk assessment integration – The findings from clinical evaluation feed into the risk management file, ensuring that any identified risks are adequately mitigated.

Challenges in clinical evaluation for class I devices

Despite their low-risk classification, manufacturers of class I devices face several challenges in clinical evaluation, including:

• Demonstrating sufficient clinical evidence – As clinical investigations are usually unnecessary for well-established devices, manufacturers must ensure that literature review and equivalence data provide robust evidence of safety and performance.
• Regulatory expectations – MDR places stringent documentation requirements on clinical evaluations, meaning even low-risk devices must have a well-structured clinical evaluation report (CER).
• Post-market data collection – Continuous monitoring through PMS and PMCF is crucial, even for simple devices, to confirm ongoing compliance with safety and performance standards.

Example 1: adhesive bandages / medical plasters

Medical plasters also known as adhesive bandages, a class I non-sterile medical device, is an example of a device where clinical evaluation is primarily based on literature review and post-market data. Since these products have been on the market for decades with a well-documented safety profile, the evaluation focuses on confirming their continued safety and performance.

Key aspects of the clinical evaluation for classic medical plasters include:

• Identifying potential risks, such as minor skin reactions (e.g., irritation, dermatitis).
• Reviewing existing literature and historical market data to confirm no significant safety concerns.
• Conducting a PMS review, which showed no reported adverse events over many years of market presence.
• Justifying the absence of instructions for use (IFU), as per MDR annex I, chapter III, para 23.1(d), due to the intuitive and well-known nature of the product.

Example 2: reusable surgical instruments

A reusable scalpel handle is another example of a class I medical device. Since it is a low-risk, non-invasive instrument, clinical evaluation would typically include:

• Equivalence justification with similar stainless steel scalpel handles that have been used in clinical practice for decades.
• Review of material safety (e.g., stainless steel biocompatibility data).
• PMS data to ensure no significant incidents have been reported.
• A risk management file that includes considerations for cleaning, sterilization, and repeated use.

Conclusion

Clinical evaluation for class I devices is a critical yet manageable regulatory requirement under MDR. While these devices do not typically require clinical investigations, manufacturers must provide sufficient clinical evidence through literature review, equivalence justification, and post-market data. Adhesive plasters and reusable surgical instruments are examples where well-documented safety records and compliance with harmonized standards allow manufacturers to demonstrate conformity efficiently. With a robust clinical evaluation and ongoing PMS, class I devices can maintain their safety and performance in line with MDR requirements.