When Regulatory Confidence Is Based on Age Rather Than Evidence

A few years ago, a Regulatory Affairs Director told me a story that has stayed with me ever since.

His team had spent several weeks re-examining a regulatory position that nobody had questioned in almost seven years. The exercise had not been triggered by a finding, a warning letter or a challenge from a notified body. There was no crisis. No corrective action. No obvious reason to revisit the decision at all.

The position had survived multiple audits, multiple product updates and several changes in personnel. By every conventional measure, it appeared stable.

That was precisely what worried him.

"We realised that nobody could explain why we still trusted it."

Not why the decision had originally been made.

Why they still trusted it.

The distinction is easy to miss, but it sits at the centre of a problem that receives surprisingly little attention in Regulatory Affairs.

Most regulatory discussions focus on change. New regulations. New guidance documents. New authority interpretations. New market requirements. Entire industries have emerged around helping organisations track these developments because everyone understands the same basic truth: yesterday's regulatory understanding may not be sufficient tomorrow.

What receives far less attention are the decisions that remain untouched for so long that organisations stop experiencing them as decisions at all.

Every regulatory organisation depends on conclusions that were reached years ago. Some determine product classification. Others define regulatory scope, market access strategies, local market assumptions or surveillance obligations. Most were established through careful analysis by experienced professionals working with the information available at the time. The question is not whether those decisions were reasonable.

The question is what happens to them afterwards.

A classification decision reached in 2020 reflected the product that existed in 2020. An applicability assessment created six years ago reflected the technologies, markets, regulations and assumptions that existed six years ago. Yet nothing about the surrounding environment remains frozen. Products evolve. Companies expand into new jurisdictions. National authorities clarify positions. Guidance accumulates. New regulatory domains emerge around technologies that barely featured in the original assessment.

The decision remains where it was first placed while the landscape around it gradually changes shape.

Most organisations recognise this dynamic when it comes to regulations. That is why they invest in regulatory monitoring. They understand that a regulatory environment can drift away from yesterday's assumptions.

What is less commonly recognised is that regulatory positions are vulnerable to exactly the same process.

The assumptions beneath them age.

A manufacturer expands into a new market and relies on an earlier assessment that was never designed for that market. A software product acquires capabilities that nobody anticipated during the original classification exercise. A local requirement is assumed to be covered elsewhere because that assumption has existed for years without creating visible problems. None of these developments automatically invalidate the original position. What they challenge is the confidence with which that position should be held.

Yet confidence rarely decreases.

If anything, it tends to increase.

The position survives another audit. Another product release. Another management review. New employees inherit it. Auditors review systems built around it. Management makes decisions based upon it. Over time, the organisation stops interacting with the original reasoning and starts interacting only with the conclusion.

Eventually, the conclusion becomes part of organisational reality.

That may explain why some of the most significant regulatory surprises appear to emerge from nowhere.

When organisations discover an overlooked local obligation, a market-specific requirement or a product characteristic that changes the regulatory assessment, the event often feels sudden. In hindsight, however, these situations rarely emerge overnight. More commonly, they sit quietly at the edge of the regulatory position for years before somebody notices them. A distributor raises a question. A market expansion forces a reassessment. A new regulatory leader challenges a long-standing assumption. The discovery feels unexpected only because nobody had previously looked in that direction.

The longer we discussed the problem, the less it resembled a regulatory issue and the more it resembled a governance issue.

Nobody in the company was failing to monitor regulations. Nobody was ignoring guidance. Nobody was neglecting their responsibilities. The organisation had simply become unable to distinguish between a position that was trusted because it had been validated and a position that was trusted because it had become familiar.

Once you notice that distinction, you start seeing it everywhere.

Engineering teams have technical debt. Cybersecurity teams talk about attack surfaces. Financial professionals monitor exposure. Regulatory Affairs lacks an equivalent vocabulary, despite experiencing something remarkably similar. Regulatory positions are not static assets. They are collections of assumptions sitting inside environments that continue to evolve. Some assumptions remain robust for years. Others quietly drift away from the reality they were originally intended to describe.

The problem is not that organisations fail to monitor change.

The problem is that very few have developed a systematic way of understanding what change means for the assumptions beneath their regulatory position.

Perhaps the most uncomfortable part of the entire discussion was the realisation that the company had no way of answering a seemingly simple question.

Which of our regulatory positions are supported by current evidence, and which are supported mainly by history?

Not because the organisation lacked expertise.

Not because the original decisions were poor.

But because nobody had ever built a process designed to tell the difference.

Regulatory Affairs has spent decades becoming better at monitoring change.

The next challenge may be something quite different: understanding how confidence itself changes over time.

Because the most dangerous regulatory positions are rarely the ones that were obviously wrong from the beginning.

They are the ones that became trusted enough that nobody thought to examine them again.

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