Clinical Evaluation under the MDR: Pathways, Requirements, and Optimal Strategy

In the journey of bringing a medical device to the EU market, providing clinical evidence is often seen as one of the biggest and most costly challenges. Many manufacturers, especially startups, often ask: "How can we demonstrate clinical benefit without investing excessive cost and time in unnecessary trials?" The answer lies in building a smart clinical evaluation strategy and strictly adhering to the requirements of the Medical Device Regulation (MDR).

A Clinical Evaluation is not just about conducting a study. It is a systematic process to continuously generate, collect, analyze, and assess clinical data related to a device to verify its safety and performance, including its clinical benefits. Essentially, this is the process by which you build a compelling, evidence-based argument that your device is safe and effective for its intended purpose.

This article will break down the core requirements of Clinical Evaluation under the MDR, explore critical pathways like demonstrating equivalence, and clarify when a clinical investigation is truly necessary.

1. The Foundation: The Clinical Evaluation Plan (CEP) and its Importance

Every good strategy begins with a good plan. Under the MDR, every manufacturer must plan, conduct, and document a Clinical Evaluation, and the foundation of this process is the Clinical Evaluation Plan (CEP).

The CEP is your detailed roadmap, outlining how you will prove conformity. A comprehensive CEP must include at least:

• An identification of the General Safety and Performance Requirements (GSPRs) that require support from relevant clinical data.
• A clear specification of the device's intended purpose, target groups, indications, and contra-indications.
• A detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters.
• Specification of methods to be used for the examination of qualitative and quantitative aspects of clinical safety.
• A list of parameters to be used to determine the acceptability of the benefit-risk ratio.
• A clinical development plan, indicating progression from exploratory investigations to confirmatory investigations and a Post-Market Clinical Follow-up (PMCF) plan.

A well-defined CEP is not just a formality; it is the strategic foundation that guides your entire clinical strategy and can save significant resources later on.

2. The Equivalence Pathway: Leveraging Existing Data

One of the most effective strategies to minimize cost and time is the equivalence pathway. Instead of generating all new clinical data, the MDR allows manufacturers to use clinical data from a device already on the market that they can demonstrate is "equivalent" to their own device.

However, claiming equivalence requires rigorous proof based on three key pillars, as outlined in Annex XIV:

• Technical: The device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties; uses similar deployment methods, where relevant; and has similar principles of operation and critical performance requirements.
• Biological: The device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and has similar release characteristics of substances.
• Clinical: The device is used for the same clinical condition or purpose, at the same site in the body, in a similar population; has the same kind of user; and has similar relevant critical performance.

Important Note: The equivalence pathway is not an easy shortcut. The MDR specifies that the characteristics must be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Furthermore, manufacturers must clearly demonstrate that they have sufficient levels of access to the data relating to the device with which they are claiming equivalence. This is a high bar and will be scrutinized heavily by a Notified Body.

3. When is a Clinical Investigation Required?

This is the most critical question for many manufacturers. The answer depends on the device's risk class.

• The General Rule: For implantable devices and Class III devices, clinical investigations are required.
• The Exceptions: A clinical investigation may not be required for these high-risk devices in the following circumstances:
  1. The device is a modification of a device already marketed by the same manufacturer, equivalence has been demonstrated and endorsed by the Notified Body, and the existing clinical evaluation is sufficient.
  2. The device is one of the specific types listed (e.g., sutures, staples, dental fillings, etc.) for which the clinical evaluation is based on sufficient clinical data and complies with relevant Common Specifications (CS), where such a CS is available.
  3. The device was lawfully placed on the market under the previous directives (MDD/AIMDD), and its clinical evaluation is based on sufficient clinical data and complies with relevant CS, where such a CS is available.

Understanding these rules helps a company determine if they must invest in a full-scale investigation or if they can leverage an existing portfolio or specific device characteristics.

4. Beyond the Launch: Post-Market Clinical Follow-up (PMCF)

The clinical evaluation process does not end when the device receives its CE mark. The MDR requires a continuous process called Post-Market Clinical Follow-up (PMCF).

PMCF is a continuous process that updates the clinical evaluation. It is a proactive plan to collect and evaluate clinical data from the real-world use of a CE-marked device. The purpose of the PMCF plan is to:

• Confirm the safety and performance of the device throughout its expected lifetime.
• Identify previously unknown side-effects and monitor identified side-effects and contraindications.
• Identify and analyze emergent risks on the basis of factual evidence.
• Ensure the continued acceptability of the benefit-risk ratio.
• Identify possible systematic misuse or off-label use of the device.

The results of the PMCF must be documented in a PMCF evaluation report, which will become part of the clinical evaluation report and the Technical Documentation.

Conclusion: Building a Smart Clinical Strategy

Clinical Evaluation under the MDR is a strategic, lifecycle-long process, not a single event. A smart clinical strategy can save significant time and money. Demonstrating equivalence is a viable path but requires thorough preparation. For high-risk devices, a clinical investigation is often unavoidable. Finally, PMCF is a mandatory part of the long-term compliance commitment.

Navigating these clinical pathways requires deep regulatory knowledge and strategic planning. With its end-to-end expertise, ITR helps clients develop the most efficient and robust clinical strategy. We assist in creating the CEP, evaluating potential equivalence claims, and designing PMCF plans that are both compliant and practical.

Let ITR help you build a solid clinical pathway, optimize resources, and bring your device to patients safely and effectively. Contact us to get started.

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