Regulatory Open Forum

Hi there,

I have a question regarding applicability of UDIs to components...

We manufacture a wheelchair component - it is not a finished medical device, it serves no direct medical purpose by itself and we sell to OEMs who fit it to the wheelchairs, which are the finished medical device. There are no sales directly to end users.

In the EU, as a component of a Class I medical device, our product itself is not classed as a medical device and therefore does not have/require a UDI.

In the US, as wheelchair components, our products are classified as Class I devices of a Class II finished product - so my question is: do we need a UDI on our products for the US?

Thanks for any guidance you can give!

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Beth Gordon
Systems Manager
Christchurch
New Zealand
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Hello Beth,

The Unique Device Identification (UDI) is from a users perspective for traceability and being able to contact the manufacturer.  If the component gets incorporated into the finished device where the end user is not fully aware, then probably does not need to have a UDI.  The FDA has published a guidance document on accessories which might be helpful to understand your situation https://www.fda.gov/media/90647/download.  There are also some information related to UDI as well, because some spare parts might be helpful having a UDI.  Though if the component is really transparent to the user, then probably does not need a UDI.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Jun-2023 17:40
From: Beth Gordon
Subject: Components and UDIs

Hi there,

I have a question regarding applicability of UDIs to components...

We manufacture a wheelchair component - it is not a finished medical device, it serves no direct medical purpose by itself and we sell to OEMs who fit it to the wheelchairs, which are the finished medical device. There are no sales directly to end users.

In the EU, as a component of a Class I medical device, our product itself is not classed as a medical device and therefore does not have/require a UDI.

In the US, as wheelchair components, our products are classified as Class I devices of a Class II finished product - so my question is: do we need a UDI on our products for the US?

Thanks for any guidance you can give!

------------------------------
Beth Gordon
Systems Manager
Christchurch
New Zealand
------------------------------

Hi Beth,

Apply FDA's UDI approach with respect to components vs. accessories.  Specifically, for the purposes of the UDI requirements:

• A component is any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. Such a component does not require a UDI, as it is not a finished device and is not cleared or approved independently from the finished device. Moreover, a replacement component does not require a UDI, even if sold separately.

In contrast,

• An accessory is a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. An accessory may be cleared or approved as a separate device. If an accessory is packaged and sold with a parent device as a "system", then the label of the overall system would be required to have its own UDI.  In such a system, the label of the accessory as packaged with the system doesn't require its own separate UDI. But an accessory requires is own UDI if it is individually labeled, packaged, and sold separately from the parent device, including as a replacement accessory.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 18-Jun-2023 17:40
From: Beth Gordon
Subject: Components and UDIs

Hi there,

I have a question regarding applicability of UDIs to components...

We manufacture a wheelchair component - it is not a finished medical device, it serves no direct medical purpose by itself and we sell to OEMs who fit it to the wheelchairs, which are the finished medical device. There are no sales directly to end users.

In the EU, as a component of a Class I medical device, our product itself is not classed as a medical device and therefore does not have/require a UDI.

In the US, as wheelchair components, our products are classified as Class I devices of a Class II finished product - so my question is: do we need a UDI on our products for the US?

Thanks for any guidance you can give!

------------------------------
Beth Gordon
Systems Manager
Christchurch
New Zealand
------------------------------

If it is classified as a Class I medical device in the U.S., you should register the establishment, register the device, and obtain UDI.  The process is relatively simple.  The challenge may be if you need to direct mark the device, so it is traceable over its useful life.  (The reason is if the system fails, you need to adhere to Medical Device Reporting and Recall requirements.)  If you already have a mechanism for labeling lot/serial number and manufacturing date on the units, then it is not so problematic; all you would need to do is to add the UDI information.  But if you have no direct marking label requirements in the E-U, then a mechanism for labeling would need to be identified.

I hope this answers your question.

------------------------------
Regina Fullin
V.P. RA/QA Consulting
Mundelein IL
United States
------------------------------

Original Message:
Sent: 18-Jun-2023 17:40
From: Beth Gordon
Subject: Components and UDIs

Hi there,

I have a question regarding applicability of UDIs to components...

We manufacture a wheelchair component - it is not a finished medical device, it serves no direct medical purpose by itself and we sell to OEMs who fit it to the wheelchairs, which are the finished medical device. There are no sales directly to end users.

In the EU, as a component of a Class I medical device, our product itself is not classed as a medical device and therefore does not have/require a UDI.

In the US, as wheelchair components, our products are classified as Class I devices of a Class II finished product - so my question is: do we need a UDI on our products for the US?

Thanks for any guidance you can give!

------------------------------
Beth Gordon
Systems Manager
Christchurch
New Zealand
------------------------------