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Unique Device Identification (UDI)

The document provides background on changes to medical device identification regulations in the US and EU. Specifically, it discusses the introduction of Unique Device Identification (UDI) system requirements in the new EU Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR). While drawing from international guidance, the EU regulations include some differences in implementation. Organizations should read the guidance, understand new UDI requirements, and develop a program to ensure compliance. The document outlines key actions for organizations to prepare for and implement UDI systems under the new regulations.

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169 views4 pages

Unique Device Identification (UDI)

The document provides background on changes to medical device identification regulations in the US and EU. Specifically, it discusses the introduction of Unique Device Identification (UDI) system requirements in the new EU Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR). While drawing from international guidance, the EU regulations include some differences in implementation. Organizations should read the guidance, understand new UDI requirements, and develop a program to ensure compliance. The document outlines key actions for organizations to prepare for and implement UDI systems under the new regulations.

Uploaded by

srdjan.djordjevic0603
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Unique device

identification (UDI)

1
Background to changes
On 24 September 2013, the US FDA published the Unique Device Identification (UDI) System Regula-
tion. In concert with the development of the US rule, the Global Harmonization Task Force (GHTF) and
then the International Medical Device Regulators Forum (IMDRF) formed working groups – both
chaired by the European Commission – that developed and published global guidance on a Unique
Device Identification System1. The document ‘…provides a framework for those regulatory authorities
that intend to develop their UDI systems that achieves a globally harmonized approach to the UDI.’
That is, if regulators follow the principles outlined in these documents, we would achieve a globally
harmonized approach to UDI.

On 5 May 2017, the EU Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and In Vitro Med-
ical Device Regulation (IVDR) (Regulation (EU) 2017/746) were published in the Official Journal of the
European Union. The MDR applies from 26 May 2020; the IVDR from 26 May 2022. Among the many
changes that the MDR and IVDR bring to the way that medical devices will be regulated in the EU is the
introduction of UDI system requirements for almost all medical devices and IVDs (and even some prod-
ucts that have not previously been regulated as medical devices – see, e.g., MDR Annex XVI). And
though the MDR/IVDR UDI system requirements are drawn heavily from the IMDRF UDI guidance docu-
ment – there are some significant implementation differences. Nevertheless, as the specific UDI
requirements are spread throughout the regulations, the IMDRF guidance document is an excellent
primer for understanding how and why the UDI system is intended to work and how the various pieces
fit together – and is worth reading and understanding as part of your UDI implementation.

See http://www.imdrf.org/docs/imdrf/final/technical/imrf-tech-131209-udi-guidance-140901.pdf
1.

and www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/ghtf-sc-n2r3-2011-unique-
device-identification-system-110916.pdf

2
Actions
1 Read and understand the IMDRF UDI system guidance and MDR/IVDR UDI requirements.

2 Understand your roles and responsibilities with respect to UDI.

3 Develop an accurate stock keeping units (SKUs) list of all devices and accessories, and their pack-
ages subject to the MDR/IVDR.

4 Determine the classification of each of these devices and accessories – this will dictate when the
label and packages will need to be UDI compliant.

5 Determine which devices are reused and reprocessed, and therefore subject to the additional
direct mark requirement.

6 Determine where the device master data are located and who owns that data. (Note: it is probably
not in a single location/system, but rather spread out across multiple systems and owners; much
of it may not even be in a system, but rather on a label or in a spreadsheet.)

7 Determine and document the roles (e.g. manufacturer, authorized representative, importers,
distributor, assembler of systems and procedure packs) and the applicable UDI responsibilities.

8 Review current labels and packages to determine where and how UDI will be applied.

9 Develop appropriate barcode implementation strategies, including barcode verification.

10 Select an issuing agency.

11 Review current SOPs and systems for inclusion of UDI.

12 Develop a UDI program and project plan.

3
Get in Touch
Smart Support is designed to outline the impact of the new regulatory changes, in order for your busi-
ness to prepare to navigate the transition and implement the new requirements.

Each Smart Support topic is written by an industry expert and reviewed by a topic expert and advisory
panel, providing you with:

An executive summary suitable for senior management

Detailed practical guidance on what has changed and what this means for your organization

Actions to take now and a summary of what is still to change

To access the full text of the MDR/IVDR Smart Support and find
out more about Compliance Navigator, contact us today.

T: +44 (0)20 8996 7029


E: [email protected]
bsigroup.com/complinav

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