Regulation (EU) 2017/745 of the European Parliament and of the Council, known as the Medical Device Regulation (MDR), introduces a number of new requirements. Following the European Commission's timetable for an EU database EUDAMED, we can soon expect key developments in the field of obligations of the importer of medical devices.
In accordance with Article 123 of the MDR and the current position of URPL, within 6 months of notifying the Commission of the full functionality of the EUDAMED bases, producer registration and importers of medical devices will become mandatory. It should be stressed that this requirement also applies to products placed on the market before that date.
Currently obligations of the importer of medical devices are limited to notifying the President of URPL of the import. However, due to the expected launch of EUDAMED, we recommend importers of medical devices carry out both procedures as quickly as possible to avoid the risk of sanctions and delays.
You may also be interested in our article on brand protection and product safety issues: Brand protection and GPSR implementation - a guide for manufacturers and distributors.
When will EUDAMED registration become mandatory?
EUDAMED is a pan-European database with the primary purpose of integrating national systems, facilitating the flow of information between actors in the supply chain and their reporting obligations. The database is public and accessible to the public as regards key information on manufacturer and importer of medical devices and the products themselves.
In accordance with the MDR Regulation, EUDAMED consists of seven electronic systems, including: product registration, the UDI code database, operator registration and the market surveillance system.
Annex VI of the MDR indicates the detailed scope of the information to be reported. In the case of a manufacturer and importer of medical devices these include:
- data identifying the entity (name, company, address),
- risk class of medical device,
- number of products per pack,
- a unique registration number (SRN),
- the name or trade name of the product.
Unique Registration Number (SRN) and Identification Code (UDI)
The key verification element for importers of medical devices are the SRN and UDI codes.
What is an SRN and how do you get one?
Unique registration number (SRN - Single Registration Number) serves to individually identify the manufacturer or importer of medical devices (and its authorised representative, if the manufacturer is not located in the EU).
Award procedure SRN is governed by Article 31(1) of the MDR and Article 19 of the Polish Medical Devices Act. Upon submission of the required data to the EUDAMED, The registrant in Poland is obliged to apply to the President of URPL for the granting of the a unique registration number. In the case of importer of medical devices The application must be accompanied by data in accordance with the KRS or CEiDG and the NIP number. The application may be submitted in person, electronically via ePUAP with a Trusted Profile, or by means of a qualified electronic signature.
Obligations of the importer regarding the UDI code
Unique identification code of the product (UDI - Unique Device Identification) is a sequence of characters that allows a specific medical device to be uniquely identified on the market. It is the responsibility of the importer of medical devices to verify that the manufacturer has assigned a UDI code to the device. This code must appear on labels and packaging. Its purpose is to enable the reporting of serious incidents and corrective actions regarding the safe use of the product.
URPL notification procedures: Notification of placing a medical device on the market
Until the entry into force of compulsory registration with EUDAMED, the rules of procedure for notification in the case of a manufacturer and notification in the case of a importer of medical devices are determined by the transitional provisions of the Polish law of 7 April 2022 on medical devices.
Under the transitional provisions, importer the obligation to notify the President of URPL within 7 days from the date of entry of the first product into the territory of Poland.
Documentation required for notification
The notification must be accompanied by the following documentation:
- the name and address of the notifier,
- the trade name of the medical device,
- the name and address of the manufacturer and the authorised representative,
- specimen signage and instructions for use,
- a copy of the CE declaration of conformity.
Attention! Documents to be submitted to the President of URPL must be translated into Polish. This is particularly the case for declarations of conformity, model markings (labels) and instructions for use, which must be comprehensible to the average consumer. Failure to notify is mandatory and allows the authority to fulfil its supervisory duties.
Requirements of the MDR regulation for Class I medical devices
The MDR Regulation provides for preferential treatment Class I medical devices due to the low level of risk. Registration of these non-invasive devices means the least amount of obligations of the importer of medical devices and manufacturer.
Article 52 of the MDR Regulation provides for no need to carry out a conformity assessment Class I device by a notified body, unless the device is intended for use in a sterile state. This regulation simplifies the procedure for marketing authorisation in the EU and allows the manufacturer to benefit from the general principle of self-certification. Nevertheless, the clinical assessment carried out should be properly documented.
Differences and risks: Importer, Manufacturer, Distributor
The MDR Regulation precisely defines the terms:
- Medical device manufacturer: A person who manufactures or has manufactured a product and offers it under his or her own name.
- Importer of medical devices: A person established in the EU who places a product from a third country on the EU market.
- Distributor of medical devices: A person in the supply chain other than the manufacturer or importer.
Increased importer responsibilities: What to look out for?
Article 16 of the MDR regulates the specific cases in which the importer takes on more responsibilities as a manufacturer. This is the case when importer makes the product available on the market under its own name or registered trademark, unless it enters into an agreement with the manufacturer as to the manufacturer's designation on the label and the continuation of its responsibility.
Interestingly, the legal obligation importer is to label a product with its own name or trademark under the sanction of an administrative fine of up to PLN 250,000. In view of this, it should be recognised that not every marketing of a product under a private label will result in increased supervision and reporting obligations, but one that does not identify alongside a person's importer also the manufacturer's identification data.
Summary and Recommendations
Obligations of the importer of medical devices following the entry into force of compulsory registration in EUDAMED and full implementation of the MDR will become more complex, but at the same time more standardised. The process requires obtaining a number of SRN, code verification UDI and continuous monitoring of medical device legislation.
It is worth taking advantage of professional support at the planning stage of procedures to avoid penalties and ensure that the product is legally marketed.
We also encourage you to read the article: How to set up a company and bring medical devices to the Polish market in 2025?.
The International Law Office of Beata Kielar - Tammert will guide you safely through the meanders of EU legalisation procedures for products and goods. Should you have any doubts or need to speak to a specialist in this or any other legal aspect of introducing products and services into the EU markets, we encourage you to contact us directly by phone on +48 606608089 or to make an appointment for an online consultation at https://bktkancelaria.pl/porady-prawne-online-2/.
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