Clinical Investigation: Is It Always Required?

How many regulatory decisions are you making “just to be safe”… instead of strategically?
Under Regulation (EU) 2017/745, we see it every week: companies launching clinical investigations… when they could actually avoid them.

The result?
Months lost
Budget wasted
Delays to market
All without real regulatory necessity.

The truth few people tell you: Article 61(6)(b)
If your device is:

• an evolution of an already CE-marked product

• supported by existing clinical data

• without significant changes to safety or intended use

you may not need a new clinical investigation.

Yes, you read that right.

What does not knowing this cost you?
A wrong decision here can mean:

• $50k – $300k in unnecessary clinical studies

• 6–12 months of delay

• internal resources tied up

• lost competitive advantage

And often, it all comes down to one simple issue: not building the right regulatory strategy.

Where most manufacturers fail
It’s not the regulation that’s the problem. It’s the interpretation.

We consistently see:

• weak, defensive CERs

• incorrect use of equivalence

• lack of a coherent PMCF strategy

• documentation that doesn’t stand up to Notified Body scrutiny

What we do (and why it matters)
At Maytal, we don’t just “write documents.”

We build a position that is robust and defensible:

• we structure strategies to avoid clinical investigations where possible

• we anticipate Notified Body objections

• we turn compliance into a competitive advantage

A simple question
If you are updating a device: are you 100% sure a clinical investigation is required?

Or are you playing it “safe”… and potentially spending hundreds of thousands unnecessarily?

Let’s keep it simple

In 15 minutes, we can start assessing and tell you:

• whether you can avoid a clinical investigation

• or if it’s truly unavoidable, how to approach an effective clinical evaluation strategy

No fluff. Don’t spend where you don’t need to.