Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. We were able to connect virtually and share ideas with our colleagues, customers and leading industry experts at our booth, during networking hours and through live sessions. It was great to have this opportunity as the global regulatory landscape is evolving at a rapid pace.  These evolutions are very important to Reed Tech as the changes to Medical Device Reporting (MDR) affect Unique Device Identification (UDI) regulations. One specific session that was of great interest was UDI & Labeling in the MDR.

The session, presented by speakers Lena Cordie-Bancroft, President of Qualitas Professional Services, Hans Strobel, CEO of dokspot GmbH, and Dr. Reinhart Seibl, Director of Regulatory Affairs at Geistlich Pharma AG, began with an in-depth review of the UDI and how it is constructed – a topic that is very familiar to Reed Tech. Furthermore, the speakers identified some very common language and abbreviations.

Short Glossary

• UDI = Unique Device Identifier a unique number or alphanumeric code that consists of two parts— DI and PI
• DI = Device Identifier critical for identification of device and device manufacturer
• PI = Production Identifier critical for traceability of device to the patient level
• AIDC = Automatic identification and data capture Any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process
• HRI = Human Readable Information

The speakers also updated attendees on what is new with EU MDR. The most recent updates took place in March and June 2020.

MDCG 2018-1 v3 (March 2020) Guidance on Basic UDI-DI and changes to UDI-DI

• The update includes information on changes to specific data elements that will trigger a new UDI-DI
• Changes to UDI-PI data element will not trigger new UDI-DI as long as there is no change to the label
• Device direct marked changes YES to NO

MDCG 2018-3 v1 (June 2020) Guidance on UDI for system and procedure packs

• The update includes another exemption example

Perhaps most importantly, they reviewed the most recent deadlines associated with the EU UDI Implementation Timeline. Each of the three major deadlines are divided by class—implantable and Class III, Class IIa and Class IIb and Class I. The current deadlines are as follows:

Labels & Packaging

• Implantable and Class III: 26 May 2021
• Class IIa and Class IIb: 26 May 2023
• Class I: 26 May 2025

Direct Marking (reusable devices) Article 27(4)

• Implantable and class III: 26 May 2023
• Class IIa and Class IIb: 26 May 2025
• Class I: 26 May 2027

Assigning Basic UDI & UDI-DI

• Implantable and Class III: 26 May 2021
• Class IIa and Class IIb: 26 May 2021
• Class I: 26 May 2021

One of the first things you will notice is that all classes of devices must meet specific UDI obligations by the EUDAMED Date of Application (DoA) 26 May 2021, enforced as of 26 May 2022. The speakers made certain to note that with the MDR delay, the dates that the UDI must be assigned to an MDR-certified device have not changed. Additionally, legacy devices are not subject to UDI obligations, other than registrations in EUDAMED (MDCG 2019-5)

Reed Tech has been closely monitoring and advising on EUDAMED for the past several years. We are happy to further explain any of these requirements or answer additional questions: [email protected].