Quick question: do you sell thermometers, blood pressure monitors, self-test kits, wound care supplies, orthoses or compression stockings? Then your pharmacy doesn't just dispense medicines — it distributes medical devices, and Regulation (EU) 2017/745 (the MDR) treats you as a distributor with obligations of your own. This isn't a stretch of the rules: it's article 14, and regional medical device inspections apply it in practice.
What article 14 actually asks of you
Before you put anything on sale, check that the product carries the CE mark and has an EU declaration of conformity; that the labelling and instructions are in the required language; that, if it comes from outside the EU, the importer is identified; and that the manufacturer has assigned a UDI where that applies. While the product is in your hands: the manufacturer's storage and transport conditions. And on an ongoing basis: a log of complaints and non-conforming products, cooperation with traceability requests, and reporting of incidents.
"My supplier will have sorted that" — no
The MDR splits up the work: the manufacturer makes the product compliant, the importer brings it into the EU compliant, and the distributor checks before selling. The whole chain answers for it, each link for its own part. In an inspection, "I trust my wholesaler" with no documented check is exactly the kind of finding inspectors are looking for.
How to comply without drowning in paperwork
The trick is to set the system up once and then keep it light: one dated verification per product/supplier, an up-to-date file of declarations, and both logs (complaints and traceability) kept alive. Dossalis packages this into a guided checklist with a pharmacy template — the usual counter products already classified — and generates the inspection kit in one click. One afternoon to get set up, and the next inspection visit goes from a scare to routine paperwork.
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Does the parapharmacy shelf count too?
If the item is a medical device (its labelling and CE mark will tell you), it counts — whatever channel it's sold through.
Do I need a qualified technician for this?
The obligations in article 14 belong to the distributing company and are organisational in nature: verify, record, be able to show it. For tricky classification questions, lean on your regulatory advisor.