Episode 1: The Origin of Medical Device "Clinical Evaluation"

The Examiner Realized: The Exam Can Be Open-Book

If we compare the regulation of medical device market launch to a "performance and safety exam," the emergence of "clinical evaluation" is like the examiner suddenly realizing: "Wait, the exam doesn't necessarily have to be taken as a closed-book test from start to finish!"

01 The "First Half" of the Story: Everyone Was Toiling Away at the "Closed-Book Exam"

A long time ago, when a manufacturer wanted to launch a new device, it was like a student taking a final exam:

• Examiner (Regulatory Authority): Prove your product is safe and effective.
• Examinee (Manufacturer): Got it! Then they worked hard to organize their own clinical trials (equivalent to "setting their own exam paper and answering it themselves").

The examiner reviews whether the exam paper meets the syllabus requirements and whether the answers are qualified. The core logic: "Practice is the absolute truth." No room for negotiation, just do it. At that time, so-called "evaluation" basically meant "conducting trials."

02 The Historical Watershed: The Examiner Gave a Smart "Green Light"

Later, the examiners discovered that some "examinees'" products looked almost identical and had similar principles to the "top student products" (i.e., equivalent devices) on the market that had already scored 100 points and been safely used for many years.

The examiner slapped their thigh:
"Hey, can these students borrow the homework and exam experience (i.e., clinical literature and data) of the top students? As long as you can prove you two are truly 'twin brothers,' can't you just directly reference the exams they've already taken?"

Once this rule of "allowing referencing the top student's homework" was established, the concept of "clinical evaluation" officially made its debut!

03 Countries' "Awakening" Moments: China and the EU as Examples

China: 2014 was a big day.
The previous regulations stated, "No matter new or old, take your own exam first." The regulations revised in 2014 explicitly stated: you can prove you look the same as the top student (equivalent device) and then cite their glorious history and exam scores. This officially recognized that "copying the top student's homework" (equivalent device comparison) is also a legal and compliant "exam shortcut."

The EU: Awakened even earlier.
In 2007, they spoke up: "Don't just say you did well on the exam; you must systematically write an analysis report telling me where your answers (evidence) come from—whether it's your own work (own data) or reasonable reference to the top student's (equivalent device data)." This mandatory "evidence analysis report" is the Clinical Evaluation Report (CER).

04 Clinical Evaluation?

Q: So, what does "clinical evaluation" do?

A: Simply put, it is a strategic process of "presenting facts and reasoning" regarding evidence.

Facing the examiner (regulatory authority), you have two basic strategies:

What is "Clinical Evaluation" — Plain Language Version

"Clinical evaluation" is the process that requires you to fully write out and clarify either of the above strategies in a rigorously logical and evidence-sufficient report (CER).

The path to product launch has changed from "you must pass the exam yourself" to two paths: the first is "you pass the exam yourself," and the second is "if you can prove you look the same as the top student (equivalent device), you can also use their exam scores." Both paths are collectively referred to as "clinical evaluation."

One more thing at the end: Through this "open-book exam" metaphor, I also want to tell our friends who follow us—this is a new mini-column called "Hardcore Soft Talk" on the Regis official account. It will be released irregularly in the future. Hope you like it.
Author: Dr. Zhang Jiange (ORCID: https://orcid.org/0000-0003-2182-8686)