Medical device inspections of distributors — pharmacies, orthopaedic shops, dental depots — tend to follow a fairly fixed script, because article 14 of the MDR is essentially a checklist. These are the six documents (or their absence) the whole visit revolves around. Use them as a dry run: if you can put all six on the table in ten minutes, you're in the good 1%.
1. Evidence of CE verification
It's not enough for the product to carry the CE mark: there has to be a record that YOU checked it — which product, which supplier, what date, who did it.
2. Labelling and instructions in the required language
The classic case: right product, box printed in Polish. The language check needs to be on your checklist, with the result written down.
3. Identification of the importer
If the product comes from outside the EU, the importer's name and address must appear on it. If they don't, that product has a problem — and so do you, if you sell it without having caught it.
4. Storage conditions
What does the manufacturer require, and how do you show you're meeting it? For most businesses it's as simple as having the conditions identified per product and the storeroom kept in order — labelled and written down.
5. Log of complaints and non-conforming products
The great missing piece across the sector. An important detail: a log that's empty but in operation counts as compliant (having it IS the obligation); a log that doesn't exist is a finding. Dossalis's kit spells it out explicitly: "the log exists and is in operation."
6. Traceability: who you bought from, who you sold to
With batch number where it applies. This is what makes a precise product recall possible, and it's what an inspector asks for when they want to see whether your system is real or just for show.
Dossalis keeps all six alive and prints them out, organised, in one click. Run the mock inspection this week — it's free and tells you exactly where you stand.
Would you pass an inspection today?
Take the inspector's test: the 6 real questions, 2 minutes, instant result. Nobody else sees your answers.
Take the free testQuick questions
How long does it take to get up to date starting from zero?
With a typical shop catalogue, one afternoon of guided setup (our €490 initial file includes us doing it for you) and a few minutes of upkeep a month after that.
What penalties are there?
They depend on the applicable penalty regime and the severity of the breach; beyond the fine itself, the real operational risk is having product taken off the shelves and the reputational damage that follows.