PMCF is not required under MDR only when the manufacturer writes a specific justification inside the post-market surveillance plan explaining why proactive post-market clinical data collection is not appropriate for the particular device. The basis is Annex XIV Part B Section 6 of Regulation (EU) 2017/745, and the justification must address each PMCF objective in Annex XIV Part B and demonstrate that the clinical picture of the device is fully characterised, the residual clinical uncertainty is effectively zero, and no new questions can be answered by further post-market clinical data. Article 61(11) still requires the clinical evaluation to be updated across the lifecycle, so the justification does not exempt the manufacturer from ongoing clinical evaluation work — only from the proactive PMCF data collection arm of it. Notified bodies scrutinise non-applicability claims carefully, and a justification that does not survive scrutiny is worse than no claim at all.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • Annex XIV Part B Section 6 of Regulation (EU) 2017/745 is the escape clause: PMCF may be declared not appropriate for a specific device if the manufacturer provides a duly substantiated justification inside the PMS plan.
  • The justification must address every PMCF objective in Annex XIV Part B one by one and show, for each, why no further proactive clinical data collection is needed for this specific device.
  • Article 61(11) still applies: the clinical evaluation must continue to be updated across the lifecycle. A non-applicability statement exempts the manufacturer from proactive PMCF data collection, not from ongoing clinical evaluation work.
  • Non-applicability is rare in practice. It fits well-characterised, long-established, low-novelty devices with narrow intended purposes, not novel startup devices with any meaningful residual clinical uncertainty.
  • Notified bodies review the justification as part of technical documentation assessment and surveillance audits. A weak justification is a documented non-conformity waiting to be written up.
  • "We are a startup and cannot afford it" is not a justification. Neither is "Class I so it does not apply" or "we will do it later." The Regulation knows none of these.

Why this post exists

Post 181 is the pillar on post-market clinical follow-up under MDR. It covers PMCF as a continuous process and explains that the default is PMCF applies, with non-applicability as the exception. Post 182 walks through how to write a PMCF plan under Annex XIV Part B. This post goes deeper into one specific question that keeps coming up in startup projects: when can we write "PMCF not applicable," and what does a justification that actually survives notified body review look like.

The question is important because the wrong answer is expensive in both directions. Over-scoping PMCF for a device that genuinely does not need it burns resources that could go into real clinical work. Under-scoping PMCF by writing a non-applicability statement that collapses on first audit destroys the CE marking timeline and forces a retrospective rebuild of the post-market clinical programme under pressure. Getting the answer right is a subtraction problem in the strict Subtract to Ship sense: keep the work that is required, cut the work that is not, and be able to defend every decision against a specific clause in the Regulation.

Annex XIV Part B Section 6 — the escape clause

The regulatory basis for PMCF non-applicability sits at the end of Annex XIV Part B. Section 6 of that Annex is the clause that allows a manufacturer to state that PMCF is not appropriate for a specific device, provided the justification is included in the post-market surveillance plan. The clause is short. It is also the only place in the Regulation where PMCF non-applicability is explicitly permitted, so every non-applicability argument must trace back to it.

Two things matter about the text. First, the justification lives inside the PMS plan required by Article 84, which sits inside the technical documentation on PMS required by Annex III. It is not a separate document and it is not optional. If the PMS plan does not contain the justification, the manufacturer has not claimed non-applicability — they have simply omitted PMCF, which is a different and worse problem.

Second, the clause requires a duly substantiated justification. "Duly substantiated" is not a placeholder. It is the legal threshold the justification has to meet. A sentence that says "PMCF is not applicable to this device" is not substantiated. A section that addresses each Annex XIV Part B objective in writing, with reference to the clinical evaluation report, the risk file, and the published clinical literature on the device and its technology, is closer to the threshold. Notified bodies read Section 6 as permissive but narrow: the door is open, but only for devices whose clinical picture is genuinely complete.

The structure of a defensible justification

A justification that survives notified body review has a recognisable structure. It does not follow a fixed template because the Regulation does not prescribe one, but every defensible version contains the same elements, in roughly the same order.

Statement of the device and its intended purpose. The justification names the specific device, the intended purpose as written in the clinical evaluation, and the risk class and conformity assessment route under Article 51. This fixes the scope of the argument. Non-applicability is always device-specific.

Link to the clinical evaluation conclusions. The justification cites the specific sections of the clinical evaluation report that establish the clinical picture of the device. It points to the pre-market evidence base, the equivalence argument if one was used, the long-term clinical history of the technology, and any existing post-market clinical experience from the legacy directive era or from equivalent devices.

Address of each Annex XIV Part B objective. This is the core of the argument. Annex XIV Part B lists the PMCF objectives: confirming the safety and performance of the device throughout its expected lifetime, identifying previously unknown side-effects and monitoring the identified side-effects and contraindications, identifying and analysing emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and identifying possible systematic misuse or off-label use of the device with a view to verifying that the intended purpose is correct. The justification takes each objective in turn and explains why no further proactive post-market clinical data collection is needed for this specific device to satisfy it.

Link to the risk management file. The justification cites the risk file under EN ISO 14971:2019 + A11:2021 and explains that every identified risk has been fully characterised by pre-market data and that no residual clinical question remains open in the risk file that PMCF could answer.

How the clinical evaluation update cycle will still run. Article 61(11) requires the clinical evaluation to be updated across the lifecycle. A non-applicability statement does not exempt the manufacturer from this obligation. The justification explains how the clinical evaluation will continue to be updated — typically through structured literature surveillance, complaint data fed back into the clinical evaluation, and monitoring of equivalent or similar devices — even though no proactive PMCF data collection is performed.

Sign-off. The justification is approved as part of the PMS plan, which means it is reviewed and signed inside the QMS alongside every other PMS plan element. This is not ceremony. It is the audit trail that shows the non-applicability decision was deliberate and documented at the right level.

For the parent walkthrough of where this sits inside the PMS plan, see the PMS plan under MDR Annex III.

When non-applicability actually works

Non-applicability works for a narrow set of devices. In the clinical files we have reviewed, it fits where all of the following hold.

The device is low-risk and well-established — typically Class I, occasionally Class IIa — with a technology that has been on the market for years or decades under the legacy directives or in clearly comparable form. The intended purpose is narrow and stable. The clinical claims are limited to what the pre-market evidence already supports with a wide margin. The residual clinical uncertainty, read honestly out of the CER and the risk file, is effectively zero — not "small," but zero. Published clinical literature on the device, equivalent devices, or the same technology is extensive and can be monitored as part of ongoing clinical evaluation without a dedicated PMCF programme. The PMS complaint channels are already structured to feed clinical signals back into the clinical evaluation, so the clinical picture stays current without a separate proactive data collection arm.

Under those conditions, non-applicability is defensible. The argument is essentially: the clinical evaluation already answers every question the Annex XIV Part B objectives require, and no new proactive activity would add to the answers. That is the only shape of argument Annex XIV Part B Section 6 accommodates.

When non-applicability does not work

Non-applicability does not work for most startup devices, and the reason is structural. Startups build novel devices. Novel devices by definition carry residual clinical uncertainty that pre-market evidence could not close. The whole point of PMCF is to close it. A novel device with a non-applicability claim is an almost certain audit non-conformity.

The cases where non-applicability fails at audit are recognisable. A novel Class IIa software device with AI components and a non-applicability claim fails because the clinical performance of an AI algorithm in real-world populations can never be fully characterised pre-market. A Class IIb implantable or surgical device with a non-applicability claim fails because Article 61(11) specifically ties PMCF data to the annual CER update for these classes, and the existence of that tie implies PMCF is expected. A Class I measuring device with a non-applicability claim fails if the measurement has any diagnostic implication the CER has not fully closed. A device with a wide or evolving intended purpose fails because the intended purpose itself cannot be verified without PMCF data on real-world use.

"We are a startup and cannot afford it" is not a justification the Regulation knows. Neither is "our notified body did not ask about it" (they will), "we will start PMCF after launch" (too late, the plan is required before CE marking), or "the device is Class I so PMCF is optional" (class alone does not exempt — Annex XIV Part B Section 6 still requires a substantiated justification for any class). Founders who try these arguments end up with the same outcome: a documented finding, a corrective action plan, and a PMCF programme built retrospectively under audit pressure.

The notified body review of the justification

Notified bodies review the non-applicability justification as part of technical documentation assessment and again during surveillance audits. The reviewer reads the justification against Annex XIV Part B Section 6 and against the clinical evaluation report, and asks three questions.

Does the justification address every Annex XIV Part B objective explicitly, in writing, for this specific device? A justification that skips any of the five objectives is incomplete. Does each element of the justification trace to a specific conclusion in the clinical evaluation report and a specific entry in the risk file? A justification that asserts completeness without the tracing is a claim, not an argument. Is the assertion that the clinical picture is complete consistent with the actual evidence base of the device — its novelty, its history, its technology, its intended purpose? A justification that says the clinical picture is complete for a device with three years of pre-market data and an AI component will not survive this question.

If the reviewer can answer yes to all three, the non-applicability claim stands and the file moves forward. If not, the reviewer writes a finding, and the manufacturer either rewrites the justification with better substance or retires the claim and builds a PMCF plan. The second outcome is far more common than the first, and it is always cheaper to build the PMCF plan in the first place than to rebuild it after a finding.

Common mistakes in non-applicability claims

Six mistakes recur across the non-applicability claims we have seen.

Treating the justification as boilerplate. A paragraph that could be pasted into any PMS plan for any device is not a justification. The justification must be specific to the device, the clinical evaluation, and the risk file.

Skipping Annex XIV Part B objectives. A justification that addresses three of the five objectives is not "mostly compliant." It is incomplete. Every objective has to be addressed or the claim fails on its face.

Confusing non-applicability with deferral. Annex XIV Part B Section 6 does not allow a manufacturer to postpone PMCF until later. The justification is a statement that PMCF is not appropriate at all, not that it will be built later. Any "we will do this after launch" language converts the claim into an admission that PMCF is applicable.

Ignoring Article 61(11). A non-applicability claim does not exempt the manufacturer from the clinical evaluation update cycle. The justification has to describe how the CER will stay current through mechanisms other than proactive PMCF, and if it does not, the clinical evaluation itself is the next finding.

Omitting the equivalent or similar device evaluation. Even when PMCF is claimed not applicable, the manufacturer still has to describe how clinical data on equivalent or similar devices will inform the CER update cycle. Skipping this element weakens every other part of the justification.

Writing the claim without Tibor-level expertise. The Annex XIV Part B objectives, the link to Article 61(11), and the interaction with Annex I Sections 1 and 9 and the risk file are tightly coupled. A justification drafted without deep understanding of how they interact tends to miss one of them, and the missing element is always the one the reviewer reads first.

The Subtract to Ship angle — a narrow door, used honestly

The Subtract to Ship framework for MDR applied to PMCF non-applicability produces a short rule. Non-applicability is a legitimate subtraction only when the work being subtracted would genuinely add no compliance value. For most startup devices, PMCF activities add compliance value because residual clinical uncertainty is real. Subtracting them in those cases is not lean, it is hollow.

The honest Subtract to Ship move for most startups is the one in post 181 and post 182: design the lightest defensible PMCF programme the device actually needs, trace every activity to an Annex XIV Part B objective and to a specific CER section or risk file entry, and cut everything that does not trace. The lightest defensible programme is almost always cheaper than a failed non-applicability claim followed by a rebuild. Reserve the Section 6 door for the narrow cases where it genuinely fits — and in those cases, write the justification at the full depth the Regulation demands.

For the methodology applied to the PMCF plan itself, see how to write a PMCF plan under Annex XIV Part B. For the lean execution walkthrough, see minimum viable PMCF for Class IIa startups.

Reality Check — where do you stand?

  1. If your PMS plan claims PMCF is not applicable, does the justification explicitly reference Annex XIV Part B Section 6 of Regulation (EU) 2017/745?
  2. Does the justification address every PMCF objective in Annex XIV Part B — confirming safety and performance, identifying previously unknown side-effects, identifying emergent risks, ensuring the benefit-risk ratio remains acceptable, identifying systematic misuse or off-label use — one by one, in writing?
  3. For each objective, does the justification trace the conclusion to a specific section of the clinical evaluation report and a specific entry in the risk file?
  4. Does the justification describe how the clinical evaluation will continue to be updated under Article 61(11) without a proactive PMCF data collection arm — typically through literature surveillance, complaint feedback, and equivalent-device monitoring?
  5. Is your device genuinely a well-characterised, low-novelty, narrow-intended-purpose device with effectively zero residual clinical uncertainty — or is the non-applicability claim a way to avoid writing a PMCF plan?
  6. Has the justification been reviewed by someone with deep MDR expertise, or was it drafted once and never reviewed?
  7. If a notified body auditor read the justification tomorrow, could every claim it makes be defended against the clinical evaluation report and the risk file without rewriting?

Frequently Asked Questions

Can any Class I device claim PMCF non-applicability by default?

No. Risk class alone does not exempt a device from PMCF. Annex XIV Part B Section 6 requires a substantiated justification for any class, and notified bodies review the justification against the Annex XIV Part B objectives regardless of whether the device is Class I, IIa, IIb, or III. Class I devices are more likely to meet the criteria for non-applicability than higher classes, but the justification still has to be written and defended.

Does a non-applicability claim exempt the manufacturer from post-market surveillance entirely?

No. Post-market surveillance is required by Articles 83 and 84 regardless of PMCF. A non-applicability claim applies only to the proactive post-market clinical follow-up arm of the PMS system. The PMS plan, the PMS report or PSUR, the complaint handling, the trend reporting, the vigilance reporting, and all other PMS obligations still apply in full.

Where exactly in the regulatory file does the justification live?

Inside the PMS plan required by Article 84, which is part of the technical documentation on PMS required by Annex III. Some manufacturers write it as a dedicated section of the PMS plan with a clear heading such as "PMCF not applicable — justification." Others keep it as a subsection of the clinical evaluation strategy referenced from the PMS plan. Either is acceptable as long as the link from the PMS plan to the justification is explicit and the justification is complete.

What happens if a non-applicability claim fails at audit?

The notified body writes a finding against Annex XIV Part B. The manufacturer has to either rebuild the justification with stronger substance or retire the claim and build a PMCF plan under the standard Annex XIV Part B requirements. In either case, the CE marking timeline is affected, the corrective action is documented, and the PMCF programme is built under audit pressure — which is always worse than building it deliberately in the first place.

Can we claim non-applicability for now and start PMCF later if the clinical picture changes?

A non-applicability claim is a statement that PMCF is not appropriate for the device. It is not a deferral mechanism. If the clinical picture changes — new claims, new risks, new indications, emerging signals from complaints or literature — the non-applicability claim has to be withdrawn and a PMCF plan has to be written. Practically, it is usually better to write a lean PMCF plan from the start than to plan for a future rebuild under pressure.

Does MDCG 2025-10 add anything to the non-applicability discussion?

MDCG 2025-10 (December 2025) is the current operational guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. It covers how PMCF fits inside the broader PMS system and how the PMS plan, the PMCF plan, and the clinical evaluation update cycle interact. It is worth reading alongside Annex XIV Part B when drafting any PMCF content, including a non-applicability justification.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 61(11) (PMCF update of clinical evaluation), Articles 83 and 84 (post-market surveillance system and plan), Annex I Sections 1 and 9 (benefit-risk determination within the general safety and performance requirements), Annex III (technical documentation on post-market surveillance), Annex XIV Part A (clinical evaluation), and Annex XIV Part B including Section 6 (post-market clinical follow-up and the non-applicability justification). Official Journal L 117, 5.5.2017.
  2. MDCG 2025-10 — Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. Medical Device Coordination Group, December 2025.
  3. EN ISO 14971:2019 + A11:2021 — Medical devices — Application of risk management to medical devices.

This post is part of the Post-Market Surveillance & Vigilance series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Annex XIV Part B Section 6 is a narrow door, and walking through it honestly is harder than building the lean PMCF programme most startup devices actually need.