The distributor is defined by Article 2(34) of the MDR 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. Article 14 of the MDR imposes far more precise obligations on the distributor than those provided for under Directive 93/42/EEC.
Mandatory verifications before making the device available
Before making a device available, the distributor must verify that the device bears CE marking and is accompanied by the EU declaration of conformity. The distributor must verify that the labelling and the IFU are in the official language of the Member State in which the device is made available. The distributor must verify that the manufacturer and the importer have fulfilled their registration obligations (UDI, EUDAMED).
If the distributor finds that the device is not in conformity, it cannot make it available until conformity has been restored. It informs the manufacturer and, where applicable, the authorised representative and the importer. Where the device presents a serious risk or is falsified, it also informs the competent authority of the Member State in which it is established (Article 14(2)).
Where a device comes from a non-EU manufacturer, also check that an EU authorised representative compliant with Article 11 MDR has been appointed.
Traceability obligations
The distributor must keep the information that makes it possible to identify the manufacturer, the importer, the devices supplied, and the professional purchasers downstream in the chain. In accordance with Article 25(2) of the MDR, this traceability must be ensured for the period referred to in Article 10(8): at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market (15 years for implantable devices).
In practice, this means a register of purchases and sales by reference and by batch, kept for the required period.
The risk of being reclassified as a manufacturer
This is the point that many distributors overlook, with potentially serious consequences. If a distributor modifies a device in a way that may affect its conformity, repackages a sterile device by altering its primary packaging, or affixes its own trademark to a device without mentioning the name of the original manufacturer, it is considered a manufacturer within the meaning of the MDR.
This reclassification entails all of the manufacturer’s obligations: technical documentation, declaration of conformity, CE marking, QMS, PMS, vigilance, PRRC. Some distributors find themselves in this situation without having anticipated it, particularly those engaged in co-branding or repackaging.
Regulatory source: Articles 10, 14 and 25 of Regulation (EU) 2017/745 — EUR-Lex