CE Mark ≠ Success: Why Regulatory Approval is Just the Beginning

A diagnostic product gets its CE mark. The press release goes out. The team celebrates.

And six months later, the product quietly disappears.

At 2B Consulting, we’ve seen this pattern repeat across the diagnostics and medtech space. Teams spend years navigating regulatory approvals — only to realize too late that regulatory success ≠ market success.

Here’s what many innovators don’t expect — and what most consultancies won’t tell you.

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1. Clinical Reality Doesn’t Care About Your Label

Getting a CE mark or FDA clearance means you’ve met the minimum requirements to enter the market — not that anyone wants your product.

Clinicians, nurses, or lab techs don’t adopt new tools because they’re legally cleared. They adopt them when:

• They trust the results.
• They understand the workflow.
• The test fits into their existing systems and routines.

A CE-marked POCT device might technically be “rapid,” but if it’s awkward to use in a chaotic ER — it won’t stick.

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2. Distribution and Reimbursement are the Hidden Bosses

It doesn’t matter how clever your tech is if:

• Distributors don’t know how to position it,
• There’s no reimbursement pathway,
• Or local clinical guidelines don’t include your method.

These factors vary wildly across Europe. What works in Germany may flop in Finland or France — even with the same regulatory clearance.

Many teams assume regulatory approval opens doors. In truth, it’s often when the real maze begins.

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3. Post-Market Commitments Can Strain You to Death

Getting your CE mark is just the start of post-market surveillance obligations under IVDR.

• Performance data updates
• Usability feedback loops
• Vigilance reporting
• Quality system overhead

If your company hasn’t built capacity (or the right partnerships) to handle this, you’ll find your team constantly reacting instead of improving.

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So, What’s the Play?

A successful diagnostic product requires early alignment between regulatory strategy, product lifecycle thinking, and market entry planning.

That’s where 2B Consulting comes in. We’ve helped teams not only achieve CE marking, but translate that clearance into real-world clinical uptake and long-term viability — across the DACH region, Nordics, and beyond.

We also speak the “cultural language” of different systems — because sometimes the difference between success and stagnation is understanding how doctors in Austria think differently than those in Finland.