MDR Annex XIV in Plain Language
The legal source, referenced at every step
Annex XIV is the part of the MDR that deals with clinical evaluation. It is also the part that catches most startups off guard.
Not because it is complicated. But because people assume it means one thing and the regulation says another.
This post walks through what Annex XIV actually requires, in plain language, with the exact legal reference for every point. All sources are from Regulation (EU) 2017/745.
First: every device needs a clinical evaluation
This surprises some founders. It should not.
Article 61(1) of the MDR says every manufacturer must plan, conduct and document a clinical evaluation. Every device. Class I included. There are no exemptions based on size, funding stage, or how simple the product seems.
Annex XIV, Part A, paragraph 2 adds that the evaluation must be thorough and objective, taking into account both good and bad data. The depth and effort required scales with the risk class and the claims you are making. A low-risk bandage and a high-risk implant both require one. They just look very different.
In plain terms: A clinical evaluation is not a one-off document. Annex XIV describes it as something you establish, update, and maintain throughout the device's lifetime. The report you write before CE marking is the start of that process, not the end of it.
→ Not sure where to start? Health Tech Pathways offers a free assessment to check whether your product falls under MDR at all. If it does, the HTP platform walks you through the clinical evaluation requirements step by step, based on the actual regulation.
The Clinical Evaluation Plan: you need this first
Before you collect any data or write any reports, you need a plan. Annex XIV, Part A, paragraph 1(a) lists what it must cover:
• Which General Safety and Performance Requirements from Annex I need clinical data to support them
• What your device is for, who it is for, and what conditions it should not be used in
• What clinical benefits you are claiming, and how you will measure them
• How you will assess the benefit-risk balance and handle any tricky components like drug substances or animal-derived materials
The plan is not a formality. It defines the scope of everything that follows. If you skip it or write it after the fact, the Clinical Evaluation Report will have gaps, and Notified Bodies will find them.
In plain terms: Write the plan at the start of development, when it can still shape your evidence strategy. It forces you to ask: what am I claiming this device does, and what will I need to prove it? That question is much cheaper to answer early than late.
→ Health Tech Pathways structures your plan against Annex XIV, Part A, paragraph 1(a). The HTP platform generates a Clinical Evaluation Plan framework mapped directly to the law, so you are not starting from a blank page and nothing gets missed.
Equivalence: more restricted than most people think
A lot of startups plan to base their clinical evaluation on data from a similar device already on the market. This is allowed. But Annex XIV, Part A, paragraph 3 sets strict conditions for it.
You have to demonstrate equivalence across three areas:
• Technical: Similar design, materials, and how it works
• Biological: Same contact materials, same tissues, similar duration of contact
• Clinical: Same condition, same site in the body, same type of patient
All three must be met. Partial equivalence does not count.
There is one more thing that changes everything for higher-risk devices. Article 61(5) says that for Class III and implantable devices, you cannot claim equivalence to a competitor's device unless you have a formal contract giving you access to their full technical documentation. In practice, competitors do not sign those contracts. So for Class III and implantable devices, you almost certainly need your own clinical data.
In plain terms: Check the equivalence question early. If the device you want to reference belongs to a competitor and your device is Class IIb implantable or Class III, you need either that access contract or your own clinical investigation. Many startups find this out too late.
→ HTP helps you assess whether the equivalence route is actually open to you. The HTP platform walks through the Annex XIV, Part A, paragraph 3 criteria against your device, so you know before you build your evidence strategy whether this route works.
The Clinical Evaluation Report: what goes in it
Annex XIV, Part A, paragraph 4 requires you to document the results of the evaluation and the clinical evidence behind them in a Clinical Evaluation Report. This report becomes part of your technical documentation and is reviewed by the Notified Body.
The most important thing the regulation says here: both favourable and unfavourable data must be included. You cannot present only the evidence that supports your device. If there is data that raises questions, it goes in too, along with your explanation of why it does not change your conclusions.
The report is not a static document either. It needs to be updated as long as the device is on the market.
In plain terms: Write the CER as if someone who is sceptical about your device will read it carefully. They will. The document needs to show not just what the evidence says, but how you assessed it and how it links to each relevant safety and performance requirement from Annex I.
→ HTP ensures your CER maps to the right Annex I requirements from the start. The HTP platform uses AI trained on MDR 2017/745 to generate structured CER documentation with direct traceability to the General Safety and Performance Requirements, reducing the gaps that trigger Notified Body queries.
PMCF: the clinical work that happens after launch
Once your device is on the market, the clinical evaluation does not stop. Annex XIV, Part B, paragraph 5 defines Post-Market Clinical Follow-Up as a continuous process that updates your clinical evaluation throughout the device's life.
The point of PMCF is to confirm the device still performs as expected in the real world, that the known risks remain acceptable, and that no new risks are emerging. The data you collect feeds back into your Clinical Evaluation Report, your risk file, and potentially your product labelling.
You need a written PMCF Plan before you go to market. Annex XIV, Part B, paragraph 6 requires it. The Notified Body will check for it during conformity assessment. And once you have collected PMCF data, paragraph 7 requires you to document the findings in a PMCF Evaluation Report that becomes part of your CER.
In plain terms: PMCF is not a future problem. Plan it before you launch. Decide what clinical questions you still want to answer after market entry, and describe specifically how you will answer them. A vague plan will not satisfy a Notified Body for anything above Class I.
→ Health Tech Pathways helps you build a PMCF plan grounded in Annex XIV, Part B. The HTP platform connects your PMCF activities back to the unresolved clinical questions from your pre-market evaluation, so the plan makes sense as a whole rather than as a checkbox exercise.
The honest summary
Annex XIV is fewer than five pages in the actual regulation. It is worth reading directly before you read any commentary about it, including this post.
The clinical evaluation process it describes is not designed to be burdensome. It is designed to make sure manufacturers actually know whether their device is safe and performs as claimed. That is a reasonable expectation.
The mistake most startups make is treating clinical evaluation as paperwork to produce rather than a process to run. The plan, the report, and the PMCF activities are outputs of thinking clearly about your device's evidence. Get the thinking right first.
Want help working through Annex XIV without getting lost?
Health Tech Pathways was built for medical device startups navigating MDR. Start with the free "MDR or not" assessment, then use the HTP platform to build your CEP, structure your CER, and plan your PMCF with AI trained specifically on MDR 2017/745. Every output traces back to the law, not to someone's opinion of it.
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All references are to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. Always verify against the current EUR-Lex version.