The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.
The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only body that can provide legally binding interpretations of Union law is the Court of Justice of the European Union.
The Unique Device Identification (UDI) system, which is introduced in Article 27 of Regulation (EU) 2017/745 on Medical Devices (MDR), intends to improve device identification and increase the efficacy of post-market safety-related actions for devices, among other things.
Particular UDI assignment solutions are envisioned to maintain proportionate data-entries in EUDAMED for some highly customized items. Therefore, until solutions are finalized, this position paper aims to clarify the implementation of UDI regulations starting on May 26, 2021, for contact lenses, spectacle frames, spectacle lenses, and ready readers.
The relevant sections of Regulations (EU) 2017/745 (particularly Chapter III and Annex VI) and associated UDI guidance materials should be studied with this position paper.
Manufacturers must abide by the requirements pertaining to the UDI system mentioned in Article 27 as well as the registration requirements mentioned in Articles 29 and 31 of the MDR, according to Article 10(7) of the MDR.
According to Article 27(3) MDR, the maker must assign a UDI to any item (except from custom-made devices) before putting it on the market. This also applies to all higher layers of packaging. Furthermore, as stipulated in Part C of Annex VI, Article 29(3) requires the makers to assign a Basic UDI-DI to the device.
UDI carriers must be listed on the device’s label and on all upper layers of packaging, according to Article 27(4) MDR. In compliance with Article 123(f) MDR, this requirement is applicable to implantable devices as well as class III, class IIa, and class IIb devices starting on May 26, 2021, class I devices starting on May 26, 2025, and class IIa and class IIb devices on May 26, 2023.
Lastly, Basic UDI-DI and the other essential data items for that device mentioned in Part B of Annex VI must be provided, according to Article 29(1) MDR. However, as stated in Article 123(3)(e) MDR, Article 29(4) MDR regarding device registration becomes effective 24 months following the date of publication of the notice mentioned in Article 34(3) MDR.
In light of the aforementioned, and taking into account that:
(a) the MDCG UDI WG is developing a specific UDI assignment solution for contact lenses, which may also be extended to spectacle frames; and
(b) while a specific UDI assignment solution is agreed upon for spectacle lenses and ready readers, its practical application has not yet been formalized, the following clarifications should be observed in terms of UDI assignment, carrier labeling, and registration.
1. UDI Assignment: As of May 26, 2021, and until particular UDI assignment solutions are finalized, the aforementioned products are anticipated to comply with the UDI assignment duties outlined in Art. 27(3) and Art. 29 (1) MDR.
2. UDI Carrier Labelling: As of May 2021, May 2023, and May 2025, respectively, implantable devices, Class III devices, Class IIa/IIb devices, and Class I devices must comply with UDI labeling regulations. Given that most of the above specified goods are Class I and Class IIa/IIb devices, it is anticipated that there will be enough time for the label to accurately reflect the UDI assignment solutions.
3. UDI & Device Registration: 24 months following the date on which the notification
