The reprocessing of medical devices and its distinction from fully refurbishing has already been discussed under the MDD and the MPG. The MDR now defines fully refurbishing for the first time. In individual cases, the distinction is not always easy to make, particularly considering the provisions on manufacturer and distributor status in Articles 10 and 16 of the MDR, but it has significant regulatory consequences. The issue of reprocessing may also be relevant in terms of trademark law.
With the entry into force of the MDR, a distinction is made between reprocessing and fully refurbishing.
Article 2(31) of the MDR defines “fully refurbishing” within the meaning of the manufacturer definition as the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation; in this case, a new lifetime begins for the refurbished devices. Fully refurbishment is not referred to anywhere else in the Regulation.
Art. 2 No. 39 MDR defines “reprocessing” as a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.
Further definitions in the MDR play a role in distinguishing between the two terms:
Art. 2 No. 28 MDR defines “placing on the market” as the first making available of a device, other than an investigational device, on the Union market.
Art. 2 No. 30 MDR defines a “manufacturer” as a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
Art. 2 No. 34 MDR defines a “distributor” as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
The meaning of the definition of fully refurbishing can therefore only be understood in conjunction with the definition of manufacturer in Art. 2 No. 30 MDR. According to this, fully refurbishing within the meaning of Art. 2 No. 31 MDR differs from simple reprocessing within the meaning of Art. 2 No. 39 MDR in that fully refurbishing creates a new medical device, the manufacturer of which becomes the refurbisher in accordance with Art. 2 No. 30 MDR.
Measures for the mere safe reuse of a medical device within the meaning of Art. 2 No. 39 MDR constitute simple reprocessing of a medical device. Even the use of individual parts from other medical devices to restore the functionality of a medical device that is already in use cannot generally justify fully refurbishing, as the restoration of the lost technical and functional safety of the used medical device is also covered by the definition of simple reprocessing in accordance with Art. 2 No. 39 MDR. On the other hand, fully refurbishing is generally assumed if the performance of the medical device has been changed. This is particularly the case in the event of a general overhaul.
It is therefore always necessary to undertake an overall assessment in each individual case. Within the framework of this overall assessment, as correctly stated in the literature, the decisive point is likely to be whether the measure is intended to present the device as new and correspondingly valuable, or whether the measures are limited to maintaining or restoring safety and functionality.
In national law, the reprocessing of medical devices is regulated by law in addition to the MDR in Sections 4 and 17b MPDG and in Sections 8 and 9 of the German Medical Devices Operator Ordinance (“MPBetreibV”). While Section 8 MPBetreibV regulates the reprocessing of reusable products, Section 9 MPBetreibV represents the German regulation of the reprocessing of single-use products (Art. 17 (1) MDR).
Section 5 MPBetreibV regulates the special requirements, stipulating that if special requirements are stipulated for an activity under this ordinance, this activity may only be carried out by persons who 1. have up-to-date knowledge of the respective activity based on suitable training or relevant professional experience, 2. is not subject to any instructions with regard to technical assessment, and 3. has the resources, in particular rooms, equipment and other work equipment, such as suitable measuring and testing facilities, that are necessary to carry out the respective activity properly and in a traceable manner.
It is correctly argued that this ultimately places the obligation on the operator to satisfy themselves that the requirements are met by both the reprocessing and testing companies. In this case, Section 12 MPDG could apply with its prohibition on placing unsafe medical devices on the market, thereby establishing a general prohibition on hazards within the life cycle of a medical device.
The user and operator have their own product monitoring obligation, which may also impose a ban on the use of the product, even if it is used properly, maintained correctly and used for its intended purpose, if there are recognisable hazards that exceed the currently applicable level.
Competitors, for their part, can take action against the improper reprocessing of medical devices, whereby the claim for injunctive relief can be based in particular on Section 3a UWG in conjunction with Section 12 MPDG and misleading information about the supposedly proper reprocessing and unsuitability of the medical device for safe use in accordance with Section 5 UWG.
Art. 16 (1) (c) MDR stipulates that anyone who modifies a device already on the market or in service in a way that could affect the device’s conformity with the applicable requirements has all the obligations of a manufacturer under the MDR. In particular, separate technical documentation and a quality or risk management system must be maintained, which must be certified, and a separate CE mark must be affixed.
Based on Art. 16 (1) (c) MDR, it should be noted that the manufacturer’s obligations may apply even if, in connection with a fully refurbishing pursuant to Art. 2 No. 31 MDR, the refurbisher does not have the status of a manufacturer pursuant to Art. 2 No. 30 MDR, for example because the refurbisher does not place the product on the market under its own name.
The issue of reprocessing may also be relevant from a trademark law perspective, although it is difficult to distinguish between reprocessing and fully refurbishing. Rather, it makes sense to distinguish as follows in commercial relations:
If only standard components and simple sealing parts are replaced during reprocessing, this is generally not relevant under trademark law. However, if central parts of the medical device are replaced during reprocessing, it can be argued that the original integrity of the medical devices has been modified. This would no longer be considered a reprocessing or repair that is insignificant in terms of trademark law but could be considered a modification under Section 24 (2) of the German Trademark Act (“MarkenG”), which precludes exhaustion under Section 24 (2) MarkenG.
In principle, therefore, at least if the reputation of the trademark or the trademark owner is damaged by the reprocessing (e.g. because this reprocessing was not carried out properly and the trademark rights are continued to be used), a claim for injunctive relief can be asserted under Section 14 (5), (2) No. 1 MarkenG.
According to the MDR, a strict distinction must be made between reprocessing and fully refurbishing. This is already evident from the different regulatory requirements and consequences: while the original manufacturer remains the manufacturer in the case of reprocessing of medical devices, the original manufacturer “loses” its manufacturer status in the case of fully refurbishing and is therefore no longer responsible for the new device. In other words, whoever fully refurbishes becomes the manufacturer or, at any rate, has the manufacturer’s obligations.
