A distributor of medical devices is, according to Article 2(34) of Regulation (EU) 2017/745, any natural or legal person in the supply chain who makes a device available on the market up to the point of putting into service, other than the manufacturer or the importer. The distributor does not place a device on the market for the first time, but rather passes on a device already present in the Union market. Nevertheless, Article 14 obliges the distributor to carry out verification, storage, record-keeping and forwarding obligations. Anyone who additionally relabels or repackages is subject to the additional requirements of Article 16, including notification, quality management and certification obligations.
Verification Obligations Before Making Available
Before making a device available on the market, a distributor shall verify that the device bears the CE marking and that the EU declaration of conformity has been drawn up, that the device is accompanied by the information to be provided by the manufacturer pursuant to Article 10(11), that for imported devices the information required under Article 13(3) from the importer is present, and that the device has been assigned a unique device identifier.
For this purpose, the distributor may use a representative sample; however, this does not apply to the verification of importer information. This takes into account that distributors usually pass on devices in sealed packaging units.
Conduct in Case of Non-Conformity
If a distributor considers or has reason to believe that a device is not in conformity, the distributor shall not make the device available until conformity has been established. The distributor shall inform the manufacturer, the manufacturer’s authorised representative and the importer. If the distributor considers that the device presents a serious risk or that the device is falsified, the distributor shall additionally inform the competent authority of the Member State in which the distributor is established.
Storage, Records and Cooperation
While a device is under the distributor’s responsibility, the distributor shall ensure that storage and transport conditions comply with the requirements set by the manufacturer. The distributor shall keep a register of complaints, non-conforming devices, and recalls and withdrawals, and shall forward complaints and reports on suspected incidents received to the manufacturer, authorised representative and importer without delay.
Upon request by an authority, the distributor shall provide the necessary information and documentation; this obligation is deemed to be fulfilled if the manufacturer or, where applicable, the authorised representative provides the relevant information. The distributor shall cooperate with corrective actions and, upon request, shall provide free samples or access to the device.
Relabelling and Repackaging
Article 16(2) clarifies that the translation of the information referred to in Annex I Section 23 and the modification of the outer packaging, including the pack size, shall not be considered as changes affecting conformity; however, for sterile devices, the original condition is compromised if the sterile barrier is opened or damaged. Any person carrying out such activities shall, pursuant to paragraph 3, indicate the activity performed and the name, registered trade name and address on the device, its packaging or in an accompanying document, and shall have in place a quality management system with procedures that ensure the accuracy and up-to-date nature of the translation, the preservation of the original condition, the absence of defects in the repackaging, and information on corrective actions by the manufacturer.
Pursuant to paragraph 4, the person shall inform the manufacturer and the competent authority at least 28 days before making the device available, shall provide a sample or model upon request, and shall submit within the same period a certificate from a notified body designated for the device type in question, confirming that the quality management system complies with paragraph 3.
Distinction from Importer, Authorised Representative and System Assembler
The importer places a device on the Union market for the first time from a third country; the distributor passes it on within the internal market. The authorised representative acts on behalf of a manufacturer from a third country and performs regulatory tasks in the manufacturer’s name, as described in the entry Authorized Representative. A person who assembles devices into a system or procedure pack is not to be treated as a distributor, because specific rules apply.
Article 16(1) also does not apply to persons who assemble or adapt an already placed-on-the-market device for an individual patient without changing the intended purpose—practically relevant for specialist retailers, medical supply stores and hospitals.
Relevance for clinical trials
In clinical investigations, devices frequently reach investigation sites via intermediate stages such as warehouses, specialist retailers or pharmacies. For investigational devices without CE marking, the distributor obligations under Article 14 do not apply in the same way, because no making available on the market occurs; responsibility for storage, allocation and documentation lies with the sponsor and must be secured through contracts and site procedures.
The situation is different for market-available comparator or ancillary devices that are obtained through regular channels and whose complaint and reporting pathways involve the distributor. Full-service CROs such as Mediconomics support sponsors and manufacturers in clearly separating these different supply routes in the study protocol, contracts and site training, so that safety reports reach the correct recipient and device allocation remains traceable.
Frequently Asked Questions (FAQ)
May a distributor verify by sampling?
Yes. Article 14(2) permits the use of a representative sample for the verification of the CE marking and declaration of conformity, the manufacturer information and the unique device identifier, but not for the verification of importer information.
Does a distributor become a manufacturer by repackaging?
No, provided only the outer packaging is modified or translated. However, the obligations under Article 16(3) and (4) then apply, including the certificate from a notified body and the 28-day period.
Must a distributor register?
The registration obligation under Article 31 applies to manufacturers, authorised representatives and importers. Distributors are not subject to it, but must verify the importer’s registration information and maintain their own records.
Regulatory References
- Regulation (EU) 2017/745, Article 2(34)—definition of distributor
- Regulation (EU) 2017/745, Article 14—general obligations of distributors
- Regulation (EU) 2017/745, Article 16(2) to (4)—relabelling, repackaging and certification obligation
- Regulation (EU) 2017/745, Article 13(3)—importer information to be verified by the distributor
- Regulation (EU) 2017/745, Annex I Section 23—information whose translation is permitted
