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Obligations of Medical Device Distributors
The entry into force of the MDR has brought many changes in the obligations and responsibilities of medical device distributors.
In this article, we will analyze the responsibilities and obligations of medical device distributors both at the European Union level and specifically in Spain.
Responsibilities of Medical Device Distributors.
Distributors of medical devices, meaning any person or company in the supply chain other than the manufacturer and importer that markets a medical device, are responsible for:
Obtaining the operating license or distribution and sales authorization in the Autonomous Community to which they belong. Before marketing a product, they will verify That the product has the CE marking and the EU declaration of conformity has been drawn up. That the product is accompanied by instructions (when necessary), correct labeling, EU Declaration of Conformity, and Notified Body Certificate (when appropriate). If it is imported products, that the importer has the operating license for those products and it is valid. That the manufacturer, if necessary, has assigned a unique UDI to the product. They are allowed to use sampling procedures for product verification. If distributors understand that a product is non-compliant, they will not introduce it to the market and will notify the manufacturer and the authorized representative. (Specific procedures for traceability and control of non-compliant products). If they consider it poses a serious risk, they will notify the competent authority (AEMPS) (specific procedures for incident management and vigilance). They will verify the UDI (when applicable). They will ensure compliance with the storage and transport requirements for the products they are responsible for. If they have received complaints, they will act by notifying the manufacturer and authorized representative to take appropriate action. (Complaint management procedure). They must maintain a record of recalls and withdrawals of products, They will provide the manufacturer, authorized representative, and importers with any information they request to enable them to investigate complaints. Maintain the documentation of medical devices for at least 10 years from their last marketing. The distributor’s details may be on the product labeling, but it is not mandatory.
Communication of Medical Devices.
On the other hand, the Royal Decree being prepared by the Spanish competent authority, which regulates medical devices, modifies the way of communication to AEMPS by economic operators who distribute them.
From its entry into force and if the draft does not change, any economic operator distributing a medical device in Spanish territory must carry out the marketing communication (except for custom-made medical devices).
To date, class I devices only had to be in the registry of medical device responsible persons, but with this modification, all medical devices regardless of the class to which they belong must be in the marketing registry.
Furthermore, it specifies that persons or companies engaged in the activity of distribution must make the communication to the communication registry.
At deviCE Sistemas, we know the necessary processes for distributors to obtain the necessary licenses and authorizations. We have experience dealing with AEMPS and the competent authorities of the Autonomous Communities, so we can help you with guaranteed success in all these procedures.