MDR Article 14: a distributor's checklist before selling a device

If you supply medical devices to the people who use them — a wholesaler, a retailer or a pharmacy — you are a distributor in the eyes of the EU Medical Device Regulation, and Article 14 gives you a short, concrete checklist to run before you make a device available. The role is defined by what you do, not your sector: a pharmacy that sells a blood-pressure monitor or a wound dressing is distributing a medical device. Here is exactly what Article 14 asks of you — and a point that saves a lot of confusion: a distributor does not register for an SRN.

Who counts as a distributor

The MDR (Regulation (EU) 2017/745) defines a distributor (Article 2(34)) as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service." A distributor is one of the five economic operators under the MDR (manufacturer, authorised representative, importer, distributor, and the system/procedure-pack producer). A pharmacy dispensing or selling a medical device fits the definition squarely.

The Article 14(2) checklist: verify before you sell

Before making a device available, a distributor must verify that all of the following are in place (Article 14(2)):

1. the device bears the CE marking and the EU declaration of conformity has been drawn up;
2. the device is accompanied by the information the manufacturer must supply — labelling and instructions for use — under Article 10(11);
3. for an imported device, the importer has complied with Article 13(3) (its name and contact details are on the device or its packaging);
4. where applicable, a UDI has been assigned by the manufacturer.

Article 14(1) frames all of this as a duty to act with due care. You do not have to open every box: the MDR lets a distributor use a representative sampling method — but only for checks 1, 2 and 4, not for the imported-device check (3). For a pharmacy, this is the practical core: confirm the CE marking and the notified-body route where relevant, confirm the instructions for use are present and in the right language, and confirm the UDI is there.

When something is wrong

If a distributor believes a device is not in conformity, Article 14(2) is strict: do not make it available until it is brought into conformity, and inform the manufacturer (and, where relevant, the authorised representative and the importer). If the device presents a serious risk or is a falsified device, also inform the competent authority of your Member State. A separate duty, Article 14(4), covers a device you have already made available and later find non-conforming: inform the operators, make sure corrective action is taken, and — for a serious risk — tell the competent authorities.

Two more standing duties matter for anyone holding stock, pharmacies included:

• Storage and transport (Article 14(3)). While a device is under your responsibility, you must keep storage and transport conditions within the limits the manufacturer set — the cold chain, humidity or handling on the label.
• Supply-chain identification (Article 25). Every economic operator must be able to tell the competent authority which economic operator supplied them a device, and which economic operator, health institution or healthcare professional they supplied it to — the records that make a recall work.

Why a distributor does not get an SRN

This is the confusion worth clearing. EUDAMED's actor registration and the Single Registration Number (SRN) are governed by Article 31 — titled "Registration of manufacturers, authorised representatives and importers." Distributors are not in that list. A pharmacy-as-distributor carries the Article 14 and Article 25 duties above, but it does not register as an actor in EUDAMED and does not receive an SRN. (For what an SRN is and who does get one, see the EUDAMED SRN explained.) Note too that individual Member States can layer national rules on top of the MDR for distributors and pharmacies — those are separate from, and additional to, the Article 14 baseline.

Using the data to run the checks

The Article 14 checklist is a lookup problem, and that is what MD Atlas is for. As of June 2026 it indexes 1,752,505 devices — an indexed subset of the public data, not the complete database. You can search a device by name, brand or UDI to confirm it is registered and read its details, or look up the manufacturer or importer behind it. The UDI you are checking on the box is the same identifier that ties the product to its record — see UDI-DI vs UDI-PI.

The short version: a distributor — your pharmacy included — must verify CE marking, the declaration of conformity, the instructions for use, importer details and the UDI before selling (Article 14), keep storage and traceability in order (Articles 14(3) and 25), and act when something is wrong — but does not need an SRN.