Missed or Late-Identified Regulatory Updates

What a regulatory update actually is — and how it is typically consumed

A regulatory update is rarely one clear, isolated event. In practice, it shows up in many different ways: a revised guidance document, a new interpretation from an authority, an updated standard, a position paper from a notified body, or a clarification buried in a Q&A or raised through supervisory expectations. Together, these updates add up to a steadily growing layer of regulatory material that sits alongside the formal legal text.

Most updates do not change the requirements themselves. Instead, they adjust how those requirements are expected to be understood and applied. The wording of the regulation may stay exactly the same, while expectations around scope, applicability, or justification shift over time. In everyday regulatory work, updates are usually handled through monitoring activities. Alerts come in, documents are reviewed, relevance is assessed, and conclusions are recorded. Responsibility for monitoring is often clearly assigned, and organisations can usually show that updates were identified and looked at. What is much less clear is what happens after that, and how those updates are actually carried into existing applicability decisions.

Detection happens — integration does not

Once a regulatory update has been identified, its impact needs to be considered in relation to existing applicability decisions, rationales, and product scopes. On paper, this means going back to earlier interpretations and checking whether the reasoning still holds. In reality, this step is often less straightforward.

Quite often, the gap only becomes visible when someone stops and asks, “Did we ever update the rationale for this?” The answer is rarely a simple yes or no. A notified body comment, an MDCG clarification, or an expectation raised informally during an audit may have been discussed, accepted, and even applied in daily work. But the applicability decision itself often remains exactly as it was written years ago.

The update lives in people’s heads, in email threads, or in meeting notes. The Applicable List, meanwhile, continues to present a tidy and settled picture — one that no longer fully reflects how the requirement is actually understood or applied. People are aware of the update, but it has never quite been integrated, and that gap often goes unnoticed until someone challenges it.

How applicability structures fall out of sync

Most Applicable Lists reflect a specific moment in time: the regulatory understanding that existed when the list was last fully reviewed. From that point on, updates tend to be handled bit by bit. Some implications are absorbed directly, while others remain implicit or are handled informally. Over time, regulatory interpretation spreads across documents, tools, and individual judgement.

The Applicable List itself is still there and still used, but it gradually stops representing a complete and up-to-date view of applicability. Nothing feels wrong as this happens. Each decision makes sense on its own. But taken together, these small gaps slowly pull the structure out of alignment with current regulatory expectations.

Where the risk materialises

When regulatory updates are not consistently absorbed into the Applicable List, the risk becomes tangible. Outdated applicability decisions can result in requirements being incorrectly marked as non-applicable or justified using rationales that no longer reflect current expectations. During audits, this typically surfaces as follow-up questions, observations, or findings — not because updates were missed, but because the organisation cannot clearly demonstrate how those updates were integrated into existing decisions.

In more serious situations, teams end up reacting under pressure. Past decisions need to be reconstructed, scope reassessed, and documentation updated outside normal governance processes. This can delay submissions, lead to corrective actions, and create inconsistencies between products or markets. Outside the audit context, outdated applicability also affects internal decisions. Product changes, market expansions, and risk assessments may rely on assumptions that are no longer valid, increasing both compliance risk and day-to-day inefficiency.

What auditors are actually reacting to

Auditors are usually not interested in whether regulatory updates were detected. Instead, they focus on whether current applicability decisions can still be justified against today’s expectations. They look for a clear link between the regulatory source, the documented rationale, and the decision that was made, and whether that link still makes sense.

When that traceability is missing or unclear, confidence in regulatory control starts to erode, even if the organisation is otherwise compliant in practice.

Applicability must be update-resilient

Regulatory change is constant, and applicability structures that rely on periodic clean-ups or individual vigilance struggle to hold up over time. To remain defensible under audit pressure, applicability needs to be able to absorb updates in a controlled and systematic way. Updates need to trigger a reassessment of existing decisions and rationales, rather than sitting alongside them as separate information.

This is not about doing more monitoring. It is about making sure applicability structures can evolve in step with regulatory interpretation.

Why this matters now

As regulatory scrutiny increases, organisations are expected to show not only that they are aware of regulatory change, but that they have control over how those changes affect applicability decisions over time. Many RA teams recognise the problem, but struggle to address it without adding workload or introducing new risk.

The gap is no longer in monitoring itself, but in how updates are absorbed into applicability governance. As part of exploring new ways to support this shift, we are preparing early access to Hoodin Compliance Studio for teams already experiencing pressure around regulatory updates and applicability maintenance. Early access is intended for organisations that recognise this challenge and want early insight into how it is being approached, as well as the opportunity to contribute perspectives grounded in real RA/QA workflows. Early Access is relevant if you want to follow how the product takes shape, share expert input, or be considered for early testing.

Join Early Access