MDR Annex XIV in Plain Language
Here is the rewritten blog post:
Most founders think clinical evaluation is a document. It is not. It is a process, and Annex XIV of the MDR defines exactly what that process requires. The founders who treat it as paperwork tend to discover the difference at the wrong moment.
You write your evidence strategy around a competitor's device. You sketch a plan to handle PMCF after launch. You assume equivalence will hold. Each of those decisions seems reasonable in isolation. Together, they become a problem that cannot be solved with money or momentum.
A quick explanation of what we are talking about
Annex XIV is the section of Regulation (EU) 2017/745 that governs clinical evaluation. It requires every manufacturer to plan, conduct, and document an assessment of whether their device is safe and performs as claimed. Every device. Every class. The output is not a single report filed before CE marking. It is a living process that continues for as long as the device is on the market.
The 3 risks that will not wait
No plan, no evaluation. Annex XIV requires a Clinical Evaluation Plan before you collect any data or write any reports. The plan defines what you are claiming, who the device is for, and what evidence you need. Without it, your Clinical Evaluation Report will have gaps. Notified Bodies look for exactly those gaps.
Equivalence is more restricted than you think. Using clinical data from a similar device on the market is allowed, but only if you can prove technical, biological, and clinical equivalence across all 3 criteria. For Class III and implantable devices, you also need a formal contract giving you access to the competitor's full technical documentation. Competitors do not sign those contracts. If your device falls into those categories, you almost certainly need your own clinical data.
PMCF is not a post-launch problem. Post-Market Clinical Follow-Up must be planned before you go to market. The Notified Body checks for a written PMCF Plan during conformity assessment. A vague plan will not pass for anything above Class I.
What starting early actually means
- Write your Clinical Evaluation Plan at the start of development, when it can still shape your evidence strategy. It forces the question: what am I claiming, and what will I need to prove it? That question costs less to answer early.
- Check whether the equivalence route is actually open before you build your evidence strategy around it. If the reference device belongs to a competitor and yours is implantable or Class III, that route may already be closed.
- Draft your PMCF Plan before you think you need it. Decide what clinical questions you still want to answer after launch, and describe specifically how you will answer them.
Before the Notified Body finds the gaps
Founders who struggle with clinical evaluation are rarely missing clinical data. They are missing clarity about what the regulation actually requires and when. That gap is almost always closed with one honest conversation before the evidence strategy is set.
If you are not sure where your evaluation stands, healthtechpathways.org offers a free 20-minute MDR assessment that can tell you before the hard decisions are made.
Take the free assessment at https://healthtechpathways.org/.
