Under the EU Medical Device Regulation (Regulation (EU) 2017/745 (MDR)), manufacturers of medical devices, other than custom-made devices, must assign a Unique Device Identification (UDI) and submit the relevant device information to the UDI database, which forms part of EUDAMED, before placing the device on the market.
EUDAMED: Key deadlines
The timetable was triggered by the Commission’s notice confirming the operational readiness of the UDI database. That notice was issued on 26 November 2025 by Decision (EU) 2025/2371 and published in the Official Journal on 27 November 2025.
As a result, groups of devices – not the individual product – placed on the market after 27 May 2026 must be registered in the UDI database before they are placed on the market. For groups of devices that were already placed on the market before 27 May 2026 but are still intended to be placed on the market after that date, the MDR provides a further twelve-month period, meaning registration must be completed by 27 November 2026.
Why registration in the UDI database matters
From a legal perspective, failure to register in time is not merely an administrative imperfection. Pursuant to the wording of Article 29(1) MDR, a device may not be placed on the market, unless it has first been registered by the manufacturer with a UDI in the UDI database. A product placed on the market without that step is non-conforming and not lawfully placed on the market. Although it may be argued that missing registration is only a formality, authorities and courts may be unwilling to accept that view because the UDI database also serves traceability, vigilance, and safety functions.
Enforcement exposure
In the Member States, non-compliance can lead to regulatory intervention. In Germany, for instance, pursuant to Section 78(1) of the German Medizinprodukterecht-Durchführungsgesetz (MPDG), the competent authority may take measures to remedy and prevent violations of the MDR. Possible outcomes include a prohibition on placing non-registered products on the market, and in theory even withdrawal, recall or seizure measures until registration is completed.
Legal exposure also extends to responsible individuals and companies under German enforcement rules. Where a device is intentionally placed on the market without prior UDI database registration, section 93(3) no. 1 MPDG may give rise to criminal liability for the responsible natural persons. Where the conduct is negligent, this may be considered an administrative offence with considerable fines.
Private enforcement and distribution risk
The risk is not limited to public enforcement. Competitors could also seek cease-and-desist relief under German unfair competition law on the basis that Article 29(1) MDR likely qualifies as a rule of market conduct. There is also a practical litigation risk arising from the largely public nature of the UDI database, which may make it easier for competitors to verify whether products have been properly registered.
Distributors also have a role in this analysis. Distributors must exercise due care under Article 14(1) MDR and must verify certain compliance elements before making devices available on the market. While it remains unclear whether their specific verification obligation expressly extends to checking UDI database registration, there is a relevant risk that distributors may take a broad view of their obligations, refuse to sell products that appear non-compliant, and potentially assert recourse or damages claims if those products are treated as defective.
Incorrect registration
A separate point is that incorrect registration may create materially similar issues. Article 27(3) MDR requires the manufacturer to ensure that device information is submitted correctly to the UDI database before the device is placed on the market, and inaccurate entries may undermine traceability, market surveillance and safety. For that reason, the principal compliance and market risks identified for non-registration can in principle also arise where a device is registered, but the entry is incomplete or inaccurate. That said, the risk of criminal or administrative proceedings appears lower in the case of incorrect registration, particularly where the issue is an accidental error or typo rather than an intentional failure to comply.
Practical takeaway
The practical message for manufacturers is therefore clear. The move from EUDAMED implementation to enforceable UDI database deadlines means that registration readiness, data accuracy and internal governance should now be treated as priority compliance items, especially for products that will continue to be placed on the market after 27 November 2026. For businesses operating in Germany, the exposure is not confined to a technical MDR issue, but extends to regulatory action, potential personal liability for responsible individuals, corporate fines, competitor challenges and distribution disruption.
