Episode 2: The Definition of Medical Device "Clinical Evaluation"

How to Take the Exam?

Last time we discussed the origin of medical device "clinical evaluation." So the question arises: what exactly is "clinical evaluation"? Is this "performance and safety exam" testing theory or practical operation? How should one prepare for it? We need to explain this step by step.

This time, let's first look at the definition of "clinical evaluation," as Confucius said, "If names are not correct, language will not be in accordance with the truth of things."

Definitions of Clinical Evaluation by Different Authorities

These three definitions seem similar; all aim to confirm the safety, clinical performance, and/or effectiveness (clinical benefits) of a medical device within its scope of application. NMPA's regulatory science system has borrowed from IMDRF's international harmonization achievements; both focus on "evaluating using existing data," and there is no substantial difference. However, there are subtle differences in the details of the definitions between NMPA/IMDRF and MDR. Regulatory documents are the result of repeated deliberation, especially the definitions of core terms, which require careful study. The differences in details reveal subtle differences in perspective and focus, directly determining the "tightness" and "rules of the game" of regulation.

An Analogy

Suppose you are a restaurant owner (manufacturer), and your "dishes" are medical devices. Now, you need to prove that your dishes are "safe and delicious" according to the rules of different "food review agencies" (regulatory authorities).

I. The "Food Review Philosophies" of Different Agencies

II. It's clearer when viewed side by side.

III. Suppose You Want to Open a "Braised Pork" Restaurant

01 Facing NMPA, you can:

• Path 1: Launch "Molecular Gastronomy Braised Pork" (brand new device), then you must organize new guests to taste it (conduct clinical trials).
• Path 2: Make traditional "Shanghai-style Braised Pork." You can prove that your method is the same as "Old Brand X Restaurant," and then cite the restaurant's decades of good reputation and food critics' reviews (clinical literature) to prove that yours is also delicious.

02 Facing MDR:

You must not only make the above choices but also write a "Long-term Quality Assurance Documentary Shooting Plan for Braised Pork" (CEP) from the very beginning and promise to continuously collect customer feedback and update shooting materials in the future.

A Few Concluding Thoughts

NMPA's definition of "clinical evaluation" focuses on the confirmation of the finished medical device. From a regulatory perspective, it fully reflects the pragmatic review approach: since what I am reviewing is the final product (the food), the manufacturer only needs to submit evidence related to the final product. How the restaurant plans its menu, how it plans the taste of the food, and how it adjusts the taste are internal matters of the restaurant; the "food critic" does not need to overstep their bounds.

MDR's definition of "clinical evaluation" starts from the process of restaurant research and dish preparation, covering the entire lifecycle of the medical device, not just the confirmation of the finished product. It demonstrates the style of a "control freak director": regardless of new or old dishes, from the first day of R&D, the restaurant must prepare a full-process documentary shooting plan from farm to table and continuously collect materials to ensure that this dish is safe and delicious now and in the future.

In terms of the connotation of the "clinical evaluation" definition, NMPA's definition can be regarded as "clinical evaluation in a narrow sense," and MDR's definition can be regarded as "clinical evaluation in a broad sense." For medical device companies, carefully savoring the "clinical evaluation" defined by regulations is the starting point for doing a good job in "clinical evaluation."

Author: Dr. Zhang Jiange (ORCID: https://orcid.org/0000-0003-2182-8686)