How Unique Device Identifiers Will Work Under MDR

The Unique Device Identifiers system under the 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 to improve 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 under MDR.

Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

Unique Device Identifiers MDR Acorn RegulatoryWhat 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 device and that is also used as the ‘access key’ to 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 serial number, lot number, software identification and manufacturing or expiry date or both types of date.

Articles 27 and 28 of MDR 2017/745 outlines the UDI system, 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 on 00353 52 61 76706 or complete the form below and we will get back to you.

Further Reading on MDR

A Guide to Drug Device Combination Products

We have produced a drug device guide that looks at the issue.  It also considers the issue in relation to the changes for drug device combination products in relation to the Medical Device Regulations.  You can download the guide here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.

About the Author
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance.
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Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues.
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