With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically.
With the MDR (Medical Device Regulation), the figures of economic operators were, at last, regulated; figures that were not fully considered in the previous European directive.
In the MDD (Medical Device Directive) only the figures of the manufacturer and the authorized representative were regulated, while with the new MDR (Medical Device Regulation) the figures of the importer and the distributor, which were not regulated in the MDD (Medical Device Directive), have also been regulated.
But who are the importer and distributor?
The importer and distributor are economic figures that have always existed commercially, even in civil law contracts that may exist with the manufacturer, however they had no discipline from the regulatory side.
In 2008 with the new legislative framerwork these figures were being delineated.
In the MDR (Medical Device Regulation) the figures of the importer and distributor are regulated correspondingly in Art.13 and Art.14, tracing the information contained in the new legislative framework.
The figure of the IMPORTER
The article enunciates that the importer is “Any natural or legal person established in the Union who places a device originating from a third country on the Union market.”
Focusing on “placing on the market,” in the MDR (Medical Device Regulation), it is regulated in Article 2.28 where it talks about the first making available of the medical device; while in Article 2.27 it states that making available is nothing more than supplying in the device.
The figure of the DISTRIBUTOR
“Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market until it is put into service.”
Both parties, therefore, have an obligation to check that the medical device is compliant with respect to the Medical Device Regulation (MDR), however, the importer has a more stringent obligation, as the regulation says that “the importer shall place on the Union market only medical devices that comply with this Regulation,” meaning that the importer must check that the product complies with all the requirements of the regulation, involving a thorough analysis and knowledge of the Medical Device Regulation (MDR).
The control over medical device distributors is less stringent than that over manufacturers. Distributors, by making a medical device available to consumers, must act in compliance with the applicable requirements. in each case there is still an analysis of the product placed on the market.
Importer and distributor: What specifically must they do?
Both the distributor and importer figure must verify that the CE marking has been affixed to the medical device and that the EU Declaration of Conformity has been drawn up.
Simple operation through the use of the Eudamed platform, although Eudamed is not yet available, can be done through the Database. However, Class I medical devices may not be listed in the Italian Data Bank but may be in the European Data Bank.
At this time, retrieving this information, i.e., verifying the declaration of conformity, may be more complex than using the Eudamed platform.
The importer will also need to verify that the manufacturer has designated an authorized representative, a requirement not required of the distributor since it is already the responsibility of the marketer. Both, however, will have to verify the correct instructions for use and compliance of the medical device.
The label claims are different from the Medical Device Directive (MDD), particularly the instructions for use. It will, therefore, be the burden of both parties to verify the compliance of the instructions for use on the label against the MDR (Medical Device Regulation).
For both the MDD (Medical Device Directive) and the MDR (Medical Device Regulation), the instructions for use in our territory must be in the Italian language, which ensures proper use of the medical device.
The Distributor must verify that the importer has complied with its obligations, specifically the importer must indicate name and location in a document accompanying the medical device so that the entire supply chain can be traced. In this way, the user or notified body knows from whom the distributor purchased and in case of problems associated with the medical device will be able to easily trace it back to the manufacturer.
Article 14 stipulates that the distributor in ‘carrying out fulfillment checks, including documentary checks, can also carry them out through a sampling method that is representative of the medical devices supplied by the manufacturer, which means that the check can be done on a sample basis and therefore the distributor is not required to check every single piece.
Both importer and distributor, in equal legislative measure, once they have completed the documentary checks at this first stage believe that the medical device is non-compliant; they must inform the manufacturer/agent, or the importer in the distributor hypothesis. If, on the other hand, they believe that such medical device poses a serious risk, they are required to notify the competent authority of the Member State in which they are established.
Both the importer and the distributor must ensure that the medical device throughout the period it remains in stock is stored according to the directions for use and to have a complaints register containing any complaints, recalls and nonconformities. This document will allow any issues related to the medical device to be better managed.
The moment both economic figures receive complaints for example from patients, health care professionals, etc. they have the obligation to keep the manufacturer/dealer informed so that the entire supply chain is kept up to date.
The presence of regulatory fulfillments provided in the new MDR (Medical Device Regulation) suggests if not obligates a definition of what are the contractual obligations between the parties.
Even if not provided for in the regulation, we know that it is the manufacturer’s burden to put in place a product surveillance plan, through which the manufacturer collects a series of information that tends to the proper functioning of the medical device.
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