Economic players, new definitions, and the roles players can play in the medical device market
With the adoption of 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 regulation, the figures of traders 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 regulation the figures of the manufacturer, the authorized representative, the importer and the distributor are regulated; therefore, with the MDR regulation, the figures of the importer and the distributor are finally regulated, which did not exist, previously, in the MDD directive.
Commercially, these figures, also existed in the MDD but had no specific discipline in the medical device sector.
As of today, the role of the importer and distributor change significantly as they become entities that have specific tasks and fulfillments that relate to the medical device sector.
A positive aspect is the relevance of going to map the entire process from upstream to downstream and vice versa, as many companies take on not just one role, but multiple roles simultaneously. For example, companies that have a role as both manufacturers and importers may also be proxies.
From an operational point of view, we therefore need to define the list of medical devices that are marketed and go on to define for those medical devices the related roles.
The traders that to date are regulated normatively in the MDR regulation are:
The Manufacturer (MDR Article 2.30)
The article says that the manufacturer is “the natural or legal person who manufactures or refurbishes a device or has it designed, manufactured or refurbished, and markets it by affixing his name or trademark to it.”
It is, therefore, absolutely permissible to have the medical device made by a third party (such as, for example, using private label).
The element that qualifies the entity as a manufacturer, remembering that manufacturer is not the one who manufactures but the one who assumes legal responsibility for the product, is that the entity ensures that that medical device complies with the regulations (e.g., CE Marking of the medical device).
THE MANDATORY (MDR Art. 2.32)
“Any natural or legal person established in the Union, who has received and accepted from the manufacturer, established outside the Union, a written mandate authorizing him to act on behalf of the manufacturer in relation to certain activities with respect to the manufacturer’s obligations under the MDR.”
The authorized representative exists only in cases where there is an extra-EU manufacturer. The authorized representative is, therefore, the responsible person on the authorized territory, accountable and interfaces with the competent authorities on the EU territory for CE marking (it is done by the manufacturer but the authorized representative is accountable). In addition, the authorized representative must have a written mandate in order for his position to be valid, through a contract governed by international law.
THE IMPORTER (MDR Art. 2.33)
The role of the importer did not exist in the previous MDD, it existed only commercially; with the MDR the commercial figure of the agent is, at last, regulated and its role defined.
The article enunciates that the importer is “Any natural or legal person established in the Union who places on the Union market a device originating in a third country.”
Focusing on “placing on the market“, in the MDR 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.
There are essentially two questions that arise:
Does first making available relate to a category of products or to the individual part?
Does placing on the market mean the physical arrival of the medical device?
Unfortunately, in the MDR regulation, this doubt is not made explicit. But in the Blue Guide this doubt is partly explained.
The Blue Guide is an EU document whose latest version is from 2016 (it covers not only medical devices, but all products subject to the “New Legislative Framework“), it is nothing but an interpretive act that gives explanations with respect to the regulations included in the various directives.
In the blue guide, it is emphasized that first making available means the individual part and not the category of products, regardless of whether it is a single specimen or a series.
But when is there provision? When does the product physically reach the market?
Making available occurs when an offer is established between two natural and legal persons, for the transfer of ownership, possession or any other right concerning the product.
Accordingly, placing on the market is not when the product is physically placed on the market, but occurs when a commercial agreement is closed between the parties.
THE DISTRIBUTOR (MDR Art. 2.34)
“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.”
All the entities described, are defined as economic operators, who have individual fulfillments and of individual items.
In conclusion, the goal of the MDR regulation is to oblige all parties in the marketing chain to have a linkage of a contractual nature. We talk about linkage because the goal of the MDR regulation is to have the ability to go back and understand the history of the medical device from upstream to downstream and vice versa. Because in the event that there are issues related to the medical device, it is necessary for the entire supply chain to be connected in order to take timely action.
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