Any medical device which is marketed in the EU contains a bar-code in a standard format. This 2D or 3D bar-code is known as Unique Device Identification or UDI. A database backs every UDI and provides users and regulators with the necessary information about the medical device.
Understanding the Registration of EU UDI in Context of MDD versus MDR
EU MDD & UDI
The EU Medical Device Directives or EU MDD does have some rare references for UDI for some specific type of devices, but it wasn’t that comprehensive as per new GS guidelines. However, the new and updated EU Medical Device Regulations contain many articles and annexes that mention requirements associated with UDI.
EU MDR & MDR
- UDI as a Basic Obligation (Article-10)
Article 10 of EU MDR labels UDI as the basic obligation for every medical device manufacturer.
- Establishment of UDI System (Article-27)
Article 27 of the EU MDR mandates the establishment of a UDI system for Europe.
- Requirements for Establishment of UDI Database (Article-28)
This article contains the requirement for the establishment of a UDI database.
- Registration of UDI (Article-29)
Manufactures working in EU markets are required to register their UDI in the database.
- Data Elements for UDI (Annex VI, Part B)
Part B of Annex VI of the EU MDR contains specific data elements that constitute the individual device UDI.
Deadline for the UDI Development
The EU MDR will come into force from May 26, 2021. Therefore, manufacturers willing to comply with EU MDR should begin the UDI development. This newly developed UDI is required for the following:
- New Technical Documentation (Annex-II);
- New EU Declaration of Conformity (Annex-IV) and
- New registration data (Annex VI, Part A).
Should the New UDI be based on the European System?
Annex II, 1.1(b) of EU MDR allows manufacturers to develop their UDI based on “a UDI system.” This can be interpreted as that manufacturers are not liable to develop their UDI based on the European UDI system only. Instead, they can prepare new technical documentation, a new declaration of conformity, and new registration data by taking another UDI system as an example (e.g. USA’s UDI).
This is also supported by Article 120 (12), which confirms that the UDI format published by GS1, AISBL, HIBCC, and ICCBBA will also be recognized in this regard.
According to Articles 123 (f) and (g), the UDI labeling will be required for the following classes of medical devices:
- UDI labeling for class III medical devices will be required from 26th May 2021.
- UDI labeling for class IIa and IIb devices will be required from 26th May 2023.
- UDI labeling for class I medical devices will be required from 26th May 2025.
Where can Manufacturers register for UDI?
To get their UDI registered, manufacturers usually have to contact an entity that has been designated by the European Commission. These entities provide manufacturers with codes that are specific to their company and products.
Designated Issuing Entities for UDI Provision
The European Commission has designated different entities for UDI provision such as:
- HIBBC (Health Industry Business Communications Council)
- IFA GmbH etc.
The Commission for Implementing Decision (EU) designated these companies as a list of entities on 6th June 2019. These companies are also providing UDI for US medical device manufacturers.
The UDI information is also required for EUDAMED, which is an IT system developed by the European Commission. As a medical device manufacturer, you should register your company and your products on EUDAMED.
Looking for your UDI Registration?
If you are a medical device manufacturer who is looking to get his UDI registered, contact Alysidia. We will help you throughout your UDI registration process. With our unmatchable expertise, we will help you in registering your UDI in both EU MDR and EUDAMED through recognized bodies.
To know more about Alysidia’s UDI registration process, you can reach us through our Contact Us page for support for various regulatory compliance solutions.