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.
The main objectives of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable, and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices that ensures a high level of safety and health while supporting innovation.”
As of May 26, 2021, a medical device can only be placed on the market or made available if it complies with the new Medical Device Regulation (MDR) 2017/745 and used in accordance with its intended purpose.
The MDR (Medical Device Regulation) Regulation establishes in Article 120 the possibility, by way of derogation from Article 5, for medical devices with a valid EC certificate under the previous Directives 90/385/EC and 93/42/EC to be placed on the market or made available until the certificate expires and no later than May 26, 2024.
The same also applies to class I medical devices according to Directives with declaration of conformity drawn up before May 26, 2021 and which, according to the MDR (Medical Device Regulation), are classified in a higher risk class with involvement for the first time of a Notified Body.
Both CE-certified medical devices and Class I medical devices under directives are now grouped under the name legacy devices.
But what are legacy devices?
Legacy devices are defined as medical devices, active implantable medical devices, and in vitro diagnostic medical devices-covered by a valid directive certificate-that will continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
In order to fully understand Article 120 MDR (Medical Device Regulation) and its application
A distinction must be made between two legal concepts:
- Placing on the market;
- Making available.
Focusing on “placing on the market,” in the MDR (Medical Device Regulation), the activity of “placing on the market” is described as the first making available of a device on the Union market (Art. 2.28), and, “making available” means the supply for distribution, consumption or use on the Union market in the course of a commercial activity of a device for consideration or free of charge (Art. 2.27).
Accordingly, it can be defined as the first supply of a medical device in the EU territory.
There are essentially two questions that arise:
- Does the first making available concern a category of products or the individual piece?
- Does placing on the market mean the physical arrival of the medical device?
Unfortunately, in the Medical Device Regulation (MDR), 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.
It stipulates that a product is placed on the market when it is made available for the first time on the Union market and that the operation is reserved for the manufacturer or the importer and, therefore, the manufacturer and the importer are the only economic operators who place products on the market.
It is also emphasized that first making available means the individual piece and not the category of products, regardless of whether it is a one-off 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.
It is important to note that within the Blue Guide it highlights the fact that the transfer can take place for consideration or free of charge and does not necessarily require the physical delivery of the product.
Assuming that the presence of the medical devices within the manufacturer’s or importer’s warehouses is not equivalent to placing the product on the market because the physical transfer of the products does not imply a contract to transfer legal ownership of the products.
The Blue Guide highlights two key concepts:
- when a manufacturer or importer supplies a product to a distributor or end user for the first time, that transaction is always designated in legal terms as “placing on the market.” Any subsequent transaction, such as from distributor to distributor or from distributor to end user, is referred to as “making available.
- First making available is defined as the individual item and not the product category, regardless of whether it is a single item or a series.
It is important to point out that within the Blue Guide there are clear references on what is not considered as placing on the market. In fact, there is no mention of placing on the market in the case of a product:
- Manufactured for personal use;
- Purchased by a consumer in a third country while physically present in that country and brought into the EU by that consumer for his or her personal use;
- Transferred by the manufacturer in a third country to an authorized representative in the Union whom the manufacturer has designated to ensure that the product complies with Union harmonization legislation;
- Introduced from a third country into the customs territory of the EU, in transit, placed in a free zone, in storage, in temporary storage or placed under another special customs procedure (temporary admission or inward processing);
- Manufactured in a Member State for export to a third country (including components supplied to a manufacturer for incorporation into a final product for export to a third country);
- Transferred for testing or validation of pre-production units considered to be still in the manufacturing stage;
- Displayed or used under controlled conditions at trade fairs, exhibitions or demonstrations;
- Present in the warehouses of the manufacturer (or its authorized representative established in the Union) or importer, but not yet made available, and therefore not supplied for distribution, consumption or use, unless otherwise provided for in existing Union harmonization legislation.
Placing on the market is the most critical time with regard to the application of the transitional provisions of the new regulatory framework to legacy devices. Indeed, this market activity determines whether a legacy medical device can continue to be made available/put into service as long as it is properly placed on the market under a valid CE certificate.
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