Article 14 diagnostic
Flash audit of your Article 14 compliance: review of processes in place, registers, incoming controls, traceability. Identification of gaps and prioritised action plan.
Duration 2 to 5 days
Medical device distributors
MDR obligations for medical device distributors: Article 14 and compliance
You distribute medical devices on the European market. The MDR makes you a fully-fledged economic operator, not a mere reseller. Article 14 imposes on you obligations of verification, traceability and reporting, enforceable before a competent authority. Many distributors discover them during an inspection. Not before.
MDR Article 14 MDCG 2021-27 Traceability Distributor vigilance
Talk to us → Scope
Distributor, importer, or both?
Article 2(34) of the MDR defines the distributor as any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market up to the point of putting into service. If you purchase a device from a manufacturer or importer established in the EU and resell it within the EU: you are a distributor. If you purchase it from a manufacturer established outside the EU: you are an importer.
MDCG 2021-27 Rev.1 (opens in a new tab) clarifies the boundaries between statuses. In case of doubt, status is assessed on a case-by-case basis according to the physical and contractual flow.
Your obligations
What the MDR requires of you, as a distributor
| Obligation | Detail |
|---|---|
| Pre-distribution verification (Art. 14 §2) | CE marking affixed, EU declaration of conformity established, manufacturer information provided in accordance with Art. 10 §11 (including instructions for use), UDI assigned where applicable, importer identified for imported devices. The distributor may proceed by representative sampling. |
| Storage and transport conditions (Art. 14 §3) | Compliance with conditions defined by the manufacturer for as long as the device is under the distributor's responsibility. For temperature-sensitive devices: documented cold chain. |
| Cooperation on corrective measures (Art. 14 §4) | If a device made available proves non-compliant: immediate notification of the manufacturer, authorised representative and importer. Cooperation on corrective measures, withdrawals or recalls. In the event of serious risk: immediate notification of the competent authorities of the Member States concerned. |
| Complaints and incident register (Art. 14 §5) | Receipt and immediate transmission to the manufacturer, authorised representative and importer of any complaint or incident report from healthcare professionals, patients or users. Maintenance of a register of complaints, non-compliant devices, recalls and withdrawals. Communication to the manufacturer on request. |
| Cooperation with competent authorities (Art. 14 §6) | Provision to the competent authority, upon request, of all information and documents necessary to demonstrate conformity. Active cooperation for any measure aimed at eliminating risks posed by devices made available. |
| Traceability data retention (Art. 25) | Identification of every economic operator to whom the distributor has supplied a device, and every operator who has supplied one to them. For implantable devices: recording and retention of the UDI. Retention periods apply in accordance with the provisions of the Regulation depending on the nature of the device. |
| Suspected non-conformity (Art. 14 §2, paragraph 3) | If the distributor considers or has reason to believe that a device is not compliant: do not make it available until brought into conformity, notify the manufacturer, authorised representative and importer. If serious risk or suspected falsified device: notify the competent authority of the Member State in which the distributor is established. |
Our services
How we support medical device distributors
Supplier verification procedure
Development of the upstream qualification procedure for manufacturers and importers, incoming controls for devices, and complaints register.
Duration 4 to 8 weeks
Preparation for a competent authority inspection
The ANSM or another EU competent authority may inspect you. We prepare your documentation and train your teams on inspection posture.
Duration 2 to 6 weeks
Regulatory watch and continuous training
Annual MDCG monitoring package, procedure updates, training for sales and logistics teams.
Duration ongoing
Quick diagnostic
Three signals that justify a rapid scoping session
- You distribute a medical device from a non-EU manufacturer and you do not know who their EC REP authorised representative is
- You have received a customer report (complaint, malfunction) and you do not know how to document it
- A manufacturer is asking you to sign a distribution contract with regulatory liability clauses you are not familiar with
Your questions
Frequently asked questions
The distributor is not responsible for the intrinsic conformity of the device (that is the manufacturer's responsibility). However, the distributor is responsible for their own obligations: pre-distribution verification, storage conditions, traceability, reporting. If you make available a device whose CE marking is manifestly absent or fraudulent, your Article 14 liability is engaged.
The MDR does not require ISO 13485 certification for distributors. However, Article 14 requires a system capable of tracing devices and complaints. A formalised quality approach (ISO 9001, or a bespoke quality system) is strongly recommended, and some manufacturers require it contractually.
Article 14 §6: do not make it available, notify the manufacturer/importer/authorised representative, notify the competent authority if the non-conformity presents a risk. Document all actions in writing. We support this incident management.
For distributors, EUDAMED registration is not a direct obligation, but you interact with EUDAMED indirectly (UDI scanning, verification of manufacturer status, etc.). Your processes must integrate these checks.
Article 14 of the MDR requires the distributor to verify, before making a device available, that it bears the CE marking, that the EU declaration of conformity has been drawn up, that the instructions for use are written in the required language and that storage and transport conditions have been respected. The distributor must also cooperate with competent authorities, report any incident of which they become aware and maintain a complaints register. They may not modify a CE-marked device without assuming the manufacturer's own obligations under Article 16.
See our MDR distributor support
See our MDR distributor support
Article 16 of the MDR is a critical point of vigilance. A distributor is reclassified as a manufacturer when they carry out any of the following operations: placing on the market under their own name or brand, modifying the intended purpose of an already marketed device, or substantially modifying the device. In that case, they assume all manufacturer obligations: QMS, technical documentation, declaration of conformity, CE marking. Simple repackaging or relabelling also triggers Article 16 if the conditions of Article 16(2) are not met. This status is not improvised.
Analyse your status under Article 16 MDR
Analyse your status under Article 16 MDR
When a distributor becomes aware of a serious incident linked to a device they market, they must immediately inform the manufacturer. If the manufacturer does not take appropriate corrective measures, the distributor may be required to notify the national competent authority directly. In France, reports are made to the ANSM via the materiovigilance platform. Reporting deadlines are strict: 15 days for a serious incident, 2 days for an incident that caused an immediate risk of death or serious deterioration of health. Traceability of exchanges with the manufacturer is essential.
Structure your vigilance process
Structure your vigilance process
Yes, this is an explicit obligation under Article 14(2) of the MDR. Before making a device available on the market, the distributor must ensure that the device bears the CE marking, that the EU declaration of conformity has been drawn up, that the mandatory information (labelling, IFU) is present and in the correct language. They must also verify that the manufacturer and, where applicable, the European authorised representative are registered on EUDAMED. Making a device available without these prior checks directly engages the distributor's liability, regardless of the device's actual conformity.
Implement your MDR verification procedures
Implement your MDR verification procedures