UDI Code Application Dates for Medical Devices

Regulation 2017/745 (MDR) divides the application dates for UDI code requirements into two parts: obtaining and applying. Obtaining means having the code available according to the procedures set by the issuing bodies; applying means using the code on labeling and packaging.

The requirements concerning the application of the UDI code for class III medical devices will be activated from May 26, 2021. Class IIa and IIb devices will follow from May 26, 2023, and class I devices from May 26, 2025.

The situation is different regarding obtaining the code alone, for which the final date is May 26, 2021, regardless of the medical device class.

Affected Medical Devices

The initial interpretation was that the dates for obtaining and applying the UDI code applied to all medical devices. This included products that will be made available on the market after May 2021 by virtue of a valid certificate under 93/42/EEC, known as legacy devices.

Specifically, Article 120 paragraph 3 of the MDR states: “However (for CE-marked devices under 93/42/EEC and made available on the market after May 26, 2021, ed.), the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices shall apply in place of the corresponding requirements in those Directives (93/42/EEC, ed.)”.

A necessary condition for device registration is precisely the availability of the UDI.

On February 15, 2021, following the first publication of this article, now updated, a new document was published by the European Commission, specific to legacy devices, which attempts to clarify the timing of registration and obtaining the UDI for such products. A detailed article will follow.

The Purpose of the UDI Code

The Unique Device Identification (UDI) system enables identification and facilitates the traceability of medical devices. Its main purpose is to improve the effectiveness of post-market activities, actions related to medical device safety, and monitoring by competent authorities.

The European Community, in the FAQ dedicated to the UDI code, also specifies that this system will play an important role in combating counterfeit devices and improving purchasing and disposal policies for devices and inventory management by healthcare facilities and economic operators.