Medical Device Regulation and the obligations for the distributor

The MDR explicitly mentions the economic operators \"Distributors\", who have special monitoring obligations and must prove these to the relevant district government in the event of monitoring.  Even though the date of application of the MDR has been postponed by one year to 26/05/2021, these obligations of the distributors are often not clear to everyone.  Therefore, we have compiled the most important obligations for you.

REGULATION (EU) 2017/745, Chapter II, Article 14, General obligations for distributors.

Before making a product available on the market, distributors shall verify that all the following requirements are met:

• Does the product have a CE marking and an EU declaration of conformity?
• Is the product supplied with the information provided by the manufacturer in accordance with Article 10(11)?
• For imported products, has the importer complied with the requirements referred to in Article 13(3)?
• Has a UDI been assigned by the manufacturer, if applicable?

Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not make the device available on the market until it has been brought into conformity and he/she shall inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer accordingly.

After making the product available on the market, distributors shall cooperate with the manufacturer and, where applicable, the manufacturer's authorised representative and the importer, and with the competent authorities to ensure that, where necessary, corrective action is taken to bring the product into conformity, to withdraw it or to recall it. Furthermore, where the distributor considers or has reason to believe that the product presents a serious risk, he shall immediately inform the competent authorities of the Member States in which he made the product available, giving details of the non-compliance and of any corrective measures taken.

The distributor is further obliged:

• To store and transport all products only in accordance with the manufacturer's instructions.
• Should the distributor receive complaints and reports from healthcare professionals, patients or users about suspected incidents related to a device they have supplied, they shall immediately forward them to the manufacturer and, where applicable, the manufacturer's authorised representative and the importer.
• Distributors shall keep a register of complaints, of non-conforming products and of recalls and withdrawals, and shall keep the manufacturer and, where applicable, the manufacturer's authorised representative and the importer informed of this surveillance activity and provide them with any information upon their request.
• Distributors shall, upon request from the competent authority, provide them with all information that is necessary to demonstrate the conformity of a product.
• The distributor's obligation shall be considered fulfilled when the manufacturer or, where applicable, the authorised representative responsible for the device in question, provides the relevant information. Distributors shall cooperate with the competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors shall, upon request, provide the relevant authority with samples of the product free of charge or, where this is not practicable, give access to the product.

The MDR increases the requirements for distributors. In this respect, this is to be regarded as positive, as it allows all parties involved to understand where the products are located.