INVENTIO – INVESTITIO – INNOVATIO
Medical devices: am I an ACTOR?
– Registration obligation for medical devices according to the regulation of European Union –
Let’s assume that a company which manufactures medical devices with a Hungarian seat not only produces, but also distributes (e.g. purchasing from a company based in EU which manufactures medical devices) products. During its activity – as before – it intends to comply with every legislation and guidelines, thereby it also pays special attention to comply with the MDR Regulation.
However, currently the compliance is not an easy job for our exemplary company, because a significant number of obligation with a significant administrative burden for the manufacturer and also for the distributor are required by the MDR Regulation.
As a result, it is obvious that it could be a main question in the exemplary company that what is exactly the EUDAMED, and as a manufacturer and distributor whether it needs to register itself and the products that are manufactured or distributed by it? If the answer is yes, where and in which database shall be the company registered?
Currently, there may be more questions than answers, therefore we intend to provide guidelines with the help of this newsletter regarding the registration obligation.
1. What is EUDAMED?
We presented the new rules of the MDR Regulation in our previous article, compared to the previous regulation of the directive, and we also referred to the reasons of the regulation. In our current summary, we present the EUDAMED (European database on medical devices) system, which records the medical devices, in particular the registration obligation.
Among the reasons of developing the EUDAMED system – among others – we can detect the increasing overall transparency, improving the coordination between the Member States, rationalizing and facilitating the information flow between the Member States and between the Commission and the Member States. For achieving these aims the Commission has started developing an integrated database.
However the EUDAMED consists of 6 modules, which are the followings:
- Actor registration (Actor module) – available from December 2020
- Unique device identification (UDI) (Module Device) – available from October 2021
- Certificate – available from October 2021
- Market Surveillance
- Clinical Investigation
2. Actor module
As of 26 May 2021 all manufacturers, authorised representatives, importers, system and pack producers must register to the ACTOR module, i.e. the aforementioned company that manufactures medical devices with a Hungarian seat must also register to the system, if it intends to place a product on the market under the MDR Regulation. The registration must be done before the products are placed on the market. In this context the difference in the terminology between placing on the market and distributing is noteworthy, because according to the provisions of the MDR, only the manufacturer and the importer may place the product on the market, whereas all economic operators in the distribution chain are entitled to distribute products placed on the market.
It is important to note that the abovementioned obligation for registration applies both to operators who place only legacy devices (see below) on the market and to operators, who no longer place device on the market, but their product has not yet been removed from the shelves, i.e. their product has not yet been eliminated from the market.
The data submitted during registration is checked by the national authority – OGYÉI – which validates the application. After that the authority informs the company via e-mail that the company has a SRN (single registration number) number. The SRN number identifies the company in all modules of the EUDAMED system.
Registration requires – among other things – the filling of a Declaration of Information Security Commitments form, a specimen of signature, a PRRC, i.e. a contract of a person responsible for ensuring regulatory compliance.
The MDR Regulation allows Member States to establish a register about distributors too. Therefore distributors and manufacturers of custom made devices (so they don’t manufacture other devices, they aren’t authorised representatives and aren’t importers) will not have to register in EUDAMED’s Actor module, but in NOR system (National Register of Medical Devices). It is already possible to register a distributor in NOR by filling in and submitting the appropriate forms published on the OGYÉI’s website. The registration applies not only to the distributor, but also to the medical device covered by the MDR Regulation, which it distributes, but legacy devices do not need to be registered.
The manufacturer and distributor of the medical devices described in the introduction will therefore have two registration obligations: on one hand as a manufacturer – you must register in the Actor module; on the other hand as a distributor – you must register in the national database.
3. DEVICE module
EUDAMED’s DEVICE module for recording devices is based on the unique device identification (UDI). The UDI is suitable for identifying not only the group of the products, but the specific product too. The institution of the UDI can be found in the regulations of the USA, but the Basic UDI is a specific feature of the European Union.
Briefly about the UDI identification:
- Basic UDI-DI (B-UDI or basic UDI-DI) is the primary identifier of the group of the assets. It must be included in several documentation (EU Declaration of Conformity, technical documentation, summary of safety and clinical performance – SSCP). The identifier also appears on Free Sales Certificate, Incident Reports and on the Periodic Safety Update Reports (PSUR) and on PMCF reports. There is no need to display the Basic UDI-DI on the packaging of the product.
- UDI-DI identifier (Device Identifier) statically identifies the specific presentation and the level of packaging of the given device type and it shall be displayed on the packaging of the device (the obligation to display it on the packaging shall be made step-by-step like the other obligations). This data must already be recorded in the device module.
- The UDI-PI is the dynamic production identifier part of the UDI identifier, which contains the given device’s variable data, such as serial number, lot number, expiry/production date, software identifier etc. The UDI-PI is not recorded in the EUDAMED database, but it is required to be legibly marked on the device packaging or directly on the device with the UDI-DI identifier (its installation will be in step-by-step).
- The Unit of Use level DIthat is assigned to link the use of the device to a specific patient in cases where the UDI is not indicated on the device label at the level of its unit of use, in practice this could mean, for example a specific surgical glove for a 50-pack of surgical gloves. The assignment of this DI number is not mandatory.
As we pointed out in our previous article, legacy devices are devices whose certification under MDD directive expires after May 26, 2021 or such Class I devices for which an already notified organization under the requirements of MDR must be involved.
Probably the biggest relief for our exemplary company is that legacy devices – to facilitate the transition to the new system – are not yet subject to UDI obligations, however the option was opened by activating the Device module.
However, legacy devices are also required to have an EUDAMED-DI – in principle – within 18 months of the full operation of Device module, and even before that in two special cases: in the event of a major incident and in the event of a notification of a security corrective action on site. The rules for the assignment of the ID are almost identical to those for the UDI.
3.1. The manufacturer’s tasks in connection with the UDI number
The obligation to allocate UDI is the obligation of the manufacturer. The obligation to allocate UDI is independent of the UDI number’s registration, and its technical possibilities, i.e. from 26 May 2021 the manufacturers must allocate UDI number to those products which are covered by the MDR Regulation. As the rules for the allocation of UDI are beyond the scope of this summary, we only refer to that obligation.
Considering the EUDAMED’s Device module is already active, currently the device registration is voluntary. Between the date of the application of the MDR (26 May 2021) and the mandatory use of the EUDAMED’s Device Module, the devices – with the distributor’s registration – shall be temporary registered to the national database.
It is important to note that all devices regardless of the risk class are subject to registration obligation, i.e. the registration under previous MDD directive, and the temporary national database does not replace the obligation to register in the EUDAMED system.
3.2. The distributor’s obligations in connection with the UDI number
The MDR Regulation makes it the distributor’s obligation to check those products it intends to distribute, including whether the appropriate UDI number can be found on the product. Currently the UDI number is only obligatory on the labels of risk class III. and implantable devices. For devices in class IIa. and IIb. from 26 May 2023, while devices in class I. from 26 May 2025 is obligatory to display the UDI number on the labels. The Basic UDI and UDI-DI number can be certified by the manufacturer. If the EUDAMED Device module is launched, these information will also be verifiable in it.
In the event of non-compliance, the distributor is obliged to inform the manufacturer and if appropriate the authorities with whom it is obliged to cooperate.
As we mentioned above, the UDI-DI and UDI-PI number must be displayed on the label, so the distributors must pay special attention to comply with the labelling requirements.
Therefore our exemplary manufacturer and distributor needs to do the followings:
- as a manufacturer it must register itself to the EUDAMED Actor Module regardless of whether it markets a device covered by MDR or a legacy device;
- it must assign an UDI number to medical devices that it manufactures and that are not considered as legacy devices;
- register the device placed on the market under the MDR in the OGYÉI database and then re-register it after mandatory use of EUDAMED Device module;
- as a distributor it must register itself and the medical it distributes under the MDR in the OGYÉI database.
The summary set out above is exclusively for informative nature, for further details we kindly ask you to contact our Firm.
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