The Unique Device Identifier system under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim of improving patient safety through better traceability and transparency. Both MDR and IVDR have similar requirements with only the implementation of timelines being different. In this article, we will focus on the needs of MDR.
What Is A Unique Device Identifier?
Article 2 (15) of the MDR 2017/745 defines a Unique Device Identifier’ (‘UDI’) as ‘a series of numeric or alphanumeric characters that are created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.
Annex VI (Part C) has the following definitions for UDI:
- Basic UDI-DI: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
- UDI-DI: The UDI-DI is a unique numeric or alphanumeric code specific to a model of the device and that is also used as the ‘access key’ to the information stored in a UDI database.
- UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include the serial number, lot number, software identification and manufacturing or expiry date or both types of date.
Articles 27 and 28 of MDR 2017/745 outline the UDI system, and UDI database respectively while Annex VI Part C describes the core data elements to be provided to the UDI database together with the UDI-DI.
What are the requirements of UDI under MDR 2017/745?
Labelling:
Medical devices must contain UDI information on their label and/or package. The UDI will comprise of a basic UDI or Device Identifier (UDI-DI) which is specific to the manufacturer and the device type.
It will also contain the production identifier (UDI-PI) which identifies the unit of device production. The information on the label must follow the global format, the UDI must be available in AIDC (automatic identification and data capture) and HRI (human readable interpretation) formats
It is also important to note that reusable devices which require cleaning, disinfection, sterilization or refurbishing between patient use must also bear the UDI on the device
Data submission to the UDI database
Annex VI Part B details the information that the manufacturer will be required to submit to the UDI database, this will include information on the medical device and the manufacturer and the UDI-DI. The UDI-DI will also be entered into the EUDAMED (European Database for Medical Devices) and so will connect all the information on a medical device throughout the system
Traceability of UDI information
Manufacturers, authorised representatives, importers, distributors, (and also, in some cases, healthcare institutions and professionals) will need to track the UDI information assigned to medical devices. Therefore, they will need to ensure their quality management system is adequate to store this information in an appropriate way.
Unique Device Identifiers Issuing agencies
The European Commission has designated four organisations as UDI Issuing Agencies to support manufacturers to comply with new regulatory requirements.
These agencies will issue the unique codes necessary for UDI, described in MDR articles 27-28, Annex VI and IVDR articles 24-25, Annex VI.
Further details are given in the Official Journal of the European Union (OJEU) of 7 June 2019. One of the four agencies is based in Europe (IFA GmbH), while to others (GS1 AISBL, HIBCC and ICCBBA) are already active for UDI requirements required by the US FDA.
Timelines for Implementation:
Currently, the timelines for implementation for devices under MDR 2017/745 are as follows:
- UDI – Class III labels May 2021
- UDI – Class IIa and IIb labels May 2023
- UDI – Class I labels May 2025
Talk To Us To Find Out More About Unique Device Identifiers
Our medical device team is currently working with a large number of companies helping them to be ready for the May 2020 deadline. If you would like to talk to us about UDI’s, or any other aspect of MDR, then please contact us at 00353 52 61 76706 or complete the form on our Contact Us page and we will get back to you.
