Responsibilites of distributors - Medical Device Regulation (EU) 2017/745 applies from May 26th
As you all may know, the new Medical Device Regulation (EU) 2017/745 (MDR) applies from May 26, 2021 forward.
This long-awaited regulation brings more scrutiny of technical documentation with it; it addresses concerns over the assessment of product safety and performance by
placing stricter requirements on clinical evaluation and post-market clinical follow-up as well as requiring better traceability of devices through the supply chain.
Responsibilities of distributors
New regulation brings more responsibilities for Economic Operators like distributors. A distributor is defined 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 it into service.
The Regulation describes the roles and responsibilities of distributors who should make sure, by representative sampling, that the devices they distribute are compliant with the obligations described in MDR Article 14. The Quality Agreement between Serres and distributors includes these requirements (MDR Article 14).
The key obligations for distributors are presented in the table below
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ENSURE/ |
CE Marking and Declaration of Conformity |
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VERIFY |
Labelling and accompanying information (IFU) |
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Manufacturer has assigned UDI |
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Importer has included name and contact details |
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OTHER |
Storage and transport requirements fulfilled |
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Keep a register of complaints, non-conforming devices, recalls and withdrawals |
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Inform manufacturer if device provides serious risk / is not in conformity |
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Reporting to competent authority re. serious incidents/serious risk |
Distributors should verify that the devices have been CE marked, an EU Declaration of Conformity has been drawn up, and that labels as well as instructions for use are provided in the official languages of the Member States in which the device is made available (or in languages accepted by those Member States). Distributors should also verify that the importer’s name is indicated on each device or in the accompanying documentation, and that the device bears a UDI.
Distributors shall ensure that storage and transport conditions, when under their responsibility, are appropriate and in line with the recommendations of the manufacturer.
If a distributor considers a device to be non-compliant with the Regulations, the device shall not be made available on the market. In this case, the distributor should inform the manufacturer. Distributors should inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health. They should also keep a register of complaints, non-conforming devices, recalls and withdrawals.
Distributors shall cooperate with authorities and make available all the documentation and information they have at their disposal.
