Placing medical devices on the market and the MDR Regulation in 2026

lacing a medical device on the European Union market requires compliance with rigorous legal, organisational and technical requirements arising directly from the MDR Regulation, i.e. Regulation (EU) 2017/745 of the European Parliament and of the Council. It is worth emphasising that the MDR, although commonly referred to as a “directive,” is in fact an EU regulation that applies directly in all Member States. The entire process of placing a device on the market is based on complete technical documentation and strict conformity control. What will change in 2026, and how can this procedure be completed safely? We explain the key obligations of manufacturers.

MDR 2026 checklist – key conditions for placing a device on the market

Before a medical device is placed on the market, the manufacturer must fulfil a number of obligations. The checklist below organises the most important requirements of the MDR Regulation:

• conducting a conformity assessment procedure – its scope depends on the risk class of the device (I, IIa, IIb, III); for higher-class devices, the involvement of a notified body is required;
• preparing complete technical documentation – compliant with Annexes II and III to the MDR, including, among other things, a device description, clinical evaluation and risk analysis;
• affixing the CE marking to the device, confirming compliance with the essential requirements of the Regulation;
• assigning the device a unique UDI identification code (Unique Device Identification), enabling the product to be tracked throughout the entire supply chain;
• mandatory registration of the device and the economic operator in the European database EUDAMED;
• implementing a quality management system and a post-market surveillance system (post-market surveillance).

Worth knowing

As of 28 May 2026, use of the EUDAMED database becomes mandatory. Following the European Commission’s announcement (27 November 2025) of the full functionality of the first four modules, the 6-month transitional period provided for in Regulation (EU) 2024/1860 began. The following modules become mandatory: actor registration, UDI/devices, notified bodies and certificates, and market surveillance. Each economic operator obtains an individual SRN registration number, and devices already on the market must be registered by 28 November 2026 at the latest.

The role of the manufacturer (Legal Manufacturer) and the contractor (OEM) in contract manufacturing

One of the most important issues in the contract manufacturing of medical devices is the precise allocation of responsibilities. The MDR Regulation clearly separates legal responsibility from the physical manufacture of the product. The roles of the two cooperating entities are distinctly different:

• Legal Manufacturer – the brand owner under whose name the device is placed on the market. It bears full regulatory responsibility: it maintains the technical documentation, is responsible for conformity assessment, affixes the CE marking, makes the entry in EUDAMED and is responsible for post-market surveillance;
• OEM / Subcontractor – a specialised manufacturing facility, such as Eubioco, responsible for the correct and repeatable execution of the manufacturing process in accordance with the entrusted documentation and the concluded quality agreement (Quality Agreement).

Understanding this distinction is crucial for any company planning to outsource production. It is the brand owner who remains formally responsible before supervisory authorities; however, the competence of the manufacturing partner directly affects the regulatory safety of the entire undertaking.

Transitional periods – until when are MDD certificates valid?

Many devices currently on the market are so-called legacy devices, certified under the repealed MDD Directive (93/42/EEC). To ensure a smooth transition to the new system, the EU legislator extended the transitional periods pursuant to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023. The different deadlines depend on the risk class of the device:

• Class III devices and implantable class IIb devices may remain on the market until 31 December 2027;
• other class IIb devices, class IIa devices and certain class I devices (sterile or with a measuring function) may be made available until 31 December 2028.

However, taking advantage of the extended deadlines is not automatic. The conditions for maintaining the validity of an MDD certificate include, among other things, implementing a quality management system compliant with the MDR and ensuring that there are no significant changes to the design and intended purpose of the device. In addition, the manufacturer had to submit a formal application for certification to the selected notified body by 26 May 2024 and sign a written agreement with it by 26 September 2024. Failure to meet these conditions means losing the right to continue using the old certificate.

Worth knowing

In the context of medical devices, it is necessary to distinguish between placing on the market (the first making available of a device on the EU market) and making available on the market (any subsequent supply of a product in the distribution chain). The extended transitional periods primarily regulate the point until which legacy devices may be legally placed on the market and made available, which is why planning reformulation and recertification should begin well in advance.

New rules for advertising medical devices and severe administrative penalties

In addition to the technical requirements of the MDR, Polish manufacturers are also subject to national advertising regulations arising from the Act of 7 April 2022 on medical devices. The advertising regulations entered into force on 1 January 2023 and introduced significant restrictions that must be taken into account as early as the stage of designing the marketing strategy. Advertising addressed to the general public (to laypersons) is subject to the following prohibitions:

• it may not use the image of persons practising medical professions or presenting themselves as such persons (the prohibition also covers actors playing the roles of doctors or nurses);
• it may not concern devices intended for use exclusively by professionals;
• it may not mislead as to the effectiveness of the device or use scientific terms that are incomprehensible to the audience.

The consequences of violations are severe. A breach of the regulations on advertising medical devices may result in an administrative fine of up to PLN 2,000,000 (where the breach may pose a threat to life or health), and in other cases up to 10% of that amount. The Act also provides for stricter sanctions for other, more serious violations – the maximum administrative fine may reach as much as PLN 5,000,000. Incorrect registration, deficiencies in MDR documentation or improper labelling may therefore represent a real, multimillion-zloty financial risk for the brand.

Choose Eubioco – a safe partner for the contract manufacturing of your medical devices

Placing medical devices on the market in the realities of 2026 is a complex process in which any formal error may result in reputational damage and multimillion-zloty penalties. Although the client remains the Legal Manufacturer and bears full regulatory responsibility, choosing the right manufacturing partner is of fundamental importance for the safety of the project. Cooperation with Eubioco means access to an experienced contractor (OEM) that guarantees:

• documentation support at the highest level – assistance in preparing technical and process documentation compliant with the MDR;
• a safe and repeatable manufacturing process – carried out in accordance with rigorous quality standards and based on a clear quality agreement;
• compliance with standards and regulatory support – including assistance with the registration process in the EUDAMED database and in relations with notified bodies.

Are you planning to introduce a medical device under your own brand? Contact our experts to discuss the scope of cooperation and receive an individual quotation. We will ensure that your product is manufactured under conditions guaranteeing full process safety and compliance with applicable regulations.

BIBLIOGRAPHY

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ EU L 117, 05.05.2017, p. 1).
2. Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (OJ EU L 80, 20.03.2023, p. 24).
3. Act of 7 April 2022 on medical devices (Journal of Laws 2022, item 974, as amended).
4. Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (2025). Transitional provisions. [online] Available at: https://www.gov.pl/web/urpl/przepisy-przejsciowe [online access: 20.05.2026]
5. Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the gradual roll-out of Eudamed (OJ EU L 2024/1860, 09.07.2024).
6. European Commission (2025). EUDAMED – notice on the functionality of the first four database modules (27.11.2025). [online] Available at: https://health.ec.europa.eu/medical-devices-eudamed/overview_en [online access: 20.05.2026]