In France, on January 21, 2020, the Ministry of Solidarity and Health and the Ministry of Action and Public Accounts have issued a decree according to which, from January 1, 2021, it will enter into force the obligation for a Distributor to enter into a distribution agreement with the Manufacturer or its Authorised Representative. The decree was published in the Official Journal of the French Republic on January 28, 2020.
Article 2, paragraph I, L. 165-1-1-1 of the Social Security Code specifies that for each health product concerned, the Distributor is obliged to enter into a distribution contract with the Manufacturer or its Authorized Representative.
The new Regulations MDR (EU) 2017/745 e IVDR (EU) 2017/746 clarify roles and responsibilities of the Economic Operators including the Distributor. Below, it is shown how this figure is defined and what its main obligations are.
The Distributor and its main obligations
A Distributor is any natural or legal person in the supply chain, other than the Manufacturer or the Importer, that makes a device available on the market, until it is put into service.
Article 14 of the MDR 2017/745 and the IVDR, defines the main obligations of the Distributor of Medical Devices. One of its main responsibilities is to ensure that the devices placed on the market comply with the requirements described.
In order to ensure compliance with the regulations, the Distributor shell verify that:
- the devices bear the “CE” marking;
- an EU declaration of conformity has been drawn up;
- labels and operating instructions are provided in the official languages of the Member States in which the device is made available;
- the name of the Importer is indicated on each device or in the accompanying documentation;
- the Manufacturer has assigned a UDI to the device.
Specific control obligations are also laid down before and after the placing on the market of the device. Moreover, charges related to post-market surveillance and to cooperation with the competent authorities are laid down too.
MDR and IVDR: what are the responsibilities and obligations of the Economic Operators?
Economic Operators of Medical Devices play an important role with regard to regulatory changes introduced by the MDR (EU) 2017/745 and by the IVDR (EU) 2017/746. For this reason we have created a white paper on the new directives defining the Economic Operators who are subject to precise obligations.
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