Your Technical Documentation Has All the Documents… So Why Isn't It Ready?

A company says its Medical Device Technical Documentation is 90% or 95% ready.

The Risk Management File exists. The Clinical Evaluation is complete. Testing has been performed. The GSPR checklist and IFU are available.

But there's an important question:

95% of what?

Having all the expected documents doesn't necessarily mean your Technical Documentation is ready for assessment. Like a puzzle, you can have every piece on the table—but if some pieces are outdated, others belong to a different version of the product, and several don't fit together, the puzzle isn't complete.

1. Start With the Product, Not Annex II

Instead of immediately opening an Annex II template and looking for documents to fill each section, start with a more fundamental question:

What exactly are we trying to certify?

Your intended purpose, patient population, intended users, use environment, indications, contraindications, lifetime, claims, variants and accessories should provide a common source of truth across the Technical Documentation.

If Marketing makes a claim that isn't reflected in the intended purpose, Clinical Evaluation or Risk Management File, you may already have a significant consistency problem.

2. Challenge Your Regulatory Assumptions

“It's Class IIa because our competitor is Class IIa” isn't a classification rationale.