IVDR gap assessment: where you stand

The IVDR transition is staggered out to 2029, which makes it easy to assume there is time. There is, but only if you know what you are missing. The manufacturers who get caught are not the ones who started late. They are the ones who thought their file was in better shape than it was.

The trap of a confident file

A technical file can look complete and still fail. The common gaps are not obvious from the inside:

• Performance evidence that met the old directive but not the new evidence bar.
• Clinical and scientific validity documented for the device, but not in the structure IVDR expects.
• Post market performance follow up planned on paper but not operational.

A Notified Body will find these. The question is whether you find them first, on your own timeline, or whether they surface in a review with a queue behind you.

What a Gap Assessment actually does

We built a proprietary IVDR Gap Analysis tool over years of doing exactly this. A Gap Assessment runs your file against it and gives you, as a fixed fee written report:

1. What is missing against the regulation, item by item.
2. What is at risk even where something exists but will not hold.
3. What to fix first, in order, so the work is a plan and not a panic.

It is deliberately productised. Fixed scope, fixed fee, no retainer. You come out of it knowing exactly where you stand and what the route looks like.

Who this is for

If you are an IVD manufacturer and you cannot say, with confidence, that your file would pass a review tomorrow, this is the cheapest way to find out where the holes are while there is still time to close them.

Start with a Gap Assessment. It is the first thing we would do anyway.