Regulatory Open Forum

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Ryan Connors
Social Media and Communications Specialist
RAPS
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This question was submitted anonymously:

"Do you know of any objective measures for data quality? Both EUDAMED and GUDID seem to have a significant proportion of gobbledegook."

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

Our IVDs generally included in most medical device UDI regulations?  I'm asking specifically for countries outside of US, EU, and MDSAP?  We sell into 125+ counties and we are trying to map out all the upcoming UDI regulations and when they are coming into force.  Most of what I can find for medical devices do not explicitly list IVDs.  Thanks.

Original Message:
Sent: 17-Apr-2024 13:02
From: Adam Price
Subject: Our members-only Ask Me Anything session on UDI starts now!

This question was submitted anonymously:

"Do you know of any objective measures for data quality? Both EUDAMED and GUDID seem to have a significant proportion of gobbledegook."

My answer: I've found that the regulatory databases have some formatting controls and data controls that require users of the database to enter certain accurate format and information. These are business rules that are applied to machine transfers of data in the GUDID system and we anticipate the same for machine transfer in the Eudamed system. The integrity of the data is driven from the manufacturers strategy for implementing and reporting UDI data to the regulatory databases. As many manufacturers struggled with strategy and data integrity in their first implementation of UDI in the US and now again here almost 8-10 years later with Euadmed, I think we see a lot of the same. I think the gobbledegook is a representation of the data entered by the manufacturers and the only ones who can check that data are the manufacturers.

------------------------------
Adam Price
RIMSYS

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

IVDs are recognized in some jurisdictions like the US under the regulations for medical devices and are recognized in others like EU as a specific type of medical devices.  In general, IVDs are regulated as medical devices and the UDI requirements associated to medical devices for the market are applicable.

Im not aware of specific countries that would have vastly different UDI requirements for medical devices vs. in Vitro devices.  In discussion, we would assume that the IVDs are covered under the medical device regulations for those cases where an IVD specific regulation is not applied.

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 13:10
From: Anonymous Member
Subject: Our members-only Ask Me Anything session on UDI starts now!

This message was posted by a user wishing to remain anonymous

Our IVDs generally included in most medical device UDI regulations?  I'm asking specifically for countries outside of US, EU, and MDSAP?  We sell into 125+ counties and we are trying to map out all the upcoming UDI regulations and when they are coming into force.  Most of what I can find for medical devices do not explicitly list IVDs.  Thanks.

Original Message:
Sent: 17-Apr-2024 13:02
From: Adam Price
Subject: Our members-only Ask Me Anything session on UDI starts now!

This question was submitted anonymously:

"Do you know of any objective measures for data quality? Both EUDAMED and GUDID seem to have a significant proportion of gobbledegook."

My answer: I've found that the regulatory databases have some formatting controls and data controls that require users of the database to enter certain accurate format and information. These are business rules that are applied to machine transfers of data in the GUDID system and we anticipate the same for machine transfer in the Eudamed system. The integrity of the data is driven from the manufacturers strategy for implementing and reporting UDI data to the regulatory databases. As many manufacturers struggled with strategy and data integrity in their first implementation of UDI in the US and now again here almost 8-10 years later with Euadmed, I think we see a lot of the same. I think the gobbledegook is a representation of the data entered by the manufacturers and the only ones who can check that data are the manufacturers.

------------------------------
Adam Price
RIMSYS

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Another anonymous question: Which jurisdictions have UDI requirements already in force, and which others are expected soon? Which jurisdictions let manufacturers submit their own database records, and which require in-country reps to handle the uploads?

My answer: Global jurisdictions are adding and updating UDI requirements frequently. We have a blog post that you can refer to, which lists the jurisdictions that currently have UDI requirements, what those requirements are, and implementation timelines. We update this post regularly as requirements are added and changed. Quick reference guide: Global UDI requirements and timelines: https://www.rimsys.io/blog/quick-reference-guide-global-udi-requirements-and-timelines-2 .

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

When do legal manufacturers should start implementing and printing UDI-DI on packaging for EU market? Do they need to wait until they receive EU MDR CE cert?

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Requirements for UDI on device labeling is applicable to all devices placed into the EU under the new MDR or IVDR regulations.  This is as of the initial go-live date in 2021.  Basically any device that manufacturer claims MDR/IVDR compliance must have the UDI-DI labeling requirements completed to be placed into the market.  

Legacy devices which claim compliance to the MDD where UDI requirements are not established are not required to meet with UDI DI labeling requirements.

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 13:11
From: Anonymous Member
Subject: Our members-only Ask Me Anything session on UDI starts now!

This message was posted by a user wishing to remain anonymous

When do legal manufacturers should start implementing and printing UDI-DI on packaging for EU market? Do they need to wait until they receive EU MDR CE cert?

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

What is the timeline to mandatorily register devices with UDI-DI assigned into EUDAMED?

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

The current timeline for mandatory UDI registration in EUDAMED is Q2 2029.  However, there are proposed changes currently in legislation to change that mandatory registration date to Jan 2026.  The likelihood of this change becoming a reality is extremely high and manufacturers should start planning for Jan 2026.

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 13:12
From: Anonymous Member
Subject: Our members-only Ask Me Anything session on UDI starts now!

This message was posted by a user wishing to remain anonymous

What is the timeline to mandatorily register devices with UDI-DI assigned into EUDAMED?

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Is there a small space or technology limitation exemption available in the EU for the UDI direct marking requirement?   If so, what is the process to apply for this exemption?    

------------------------------
Kathie Goodwin RAC
Senior Director, Global Regulatory Affairs, Drug Delivery and Digital Health
Eli Lilly - ENTERPRISE
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Annex VI, Part C, 4.10. of MDR/IVDR The requirement of this Section shall not apply to devices in the following circumstances: (a) any type of direct marking would interfere with the safety or performance of the device; (b) the device cannot be directly marked because it is not technologically feasible. The exception in the US to allow a device that has been previously marked is NOT applicable in the EU. You would need to consult with your Notified Body to determining how to apply for the exemption.

------------------------------
Bruce McKean
Director of Regulatory
Rimsys Inc.
Pittsburgh, PA
USA
bruce.mckean@rimsys.io
------------------------------

Original Message:
Sent: 17-Apr-2024 13:13
From: Kathie Goodwin
Subject: Our members-only Ask Me Anything session on UDI starts now!

Is there a small space or technology limitation exemption available in the EU for the UDI direct marking requirement?   If so, what is the process to apply for this exemption?    

------------------------------
Kathie Goodwin RAC
Senior Director, Global Regulatory Affairs, Drug Delivery and Digital Health
Eli Lilly - ENTERPRISE
Indianapolis IN
United States

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

how is Rimsys incorporating UDI as part of its RIM system?

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Rimsys RIM software simplifies the creation, maintenance, and reporting of UDI data. It also provides tools to oversee and manage the entirety of a company's UDI program through a unified solution. Here are some business outcomes supported by the Rimsys UDI module:
-Allows users to create and manage UDI attribute data from a centralized location and then apply that information to global UDI requirements, where the data requirements overlap multiple markets.
-Monitors global UDI regulatory changes and adds new country requirements directly into the platform as UDI programs are implemented and become required. Rimsys also keeps up with the latest changes to supported UDI programs for the US (FDA) EU (MDR), Saudi Arabia (SFDA), China (NMPA), South Korea (MFDS), and Singapore (HSA) and updates the required fields directly into the platform.
-Novel Universal UDI approach, which incorporates the common elements through jurisdictions and uses this single-sourced information to eliminate redundant and error-prone duplicate data.
-Supports EU MDR/IVDR requirements and EUDAMED submissions with category-level BUDI records
-Alleviates the need to manually upload UDI data into databases when relevant information changes to ensure compliance. Submit UDI data directly to the FDA health authority database with requirements gathering for EUDAMED starting soon

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 13:15
From: Anonymous Member
Subject: Our members-only Ask Me Anything session on UDI starts now!

This message was posted by a user wishing to remain anonymous

how is Rimsys incorporating UDI as part of its RIM system?

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

How is UDI handled for non-distributed software. Is it sufficient to include the UDI on the "About" page?

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Not understanding what is meant by "non-distributed software" your question will be answered for SaMD.  The UDI shall be assigned at the system level of the software. Only software that is commercially available on its own and software that constitutes a device in itself shall be subject to the UDI requirement. The UDI for SaMD must be displayed in human-readable format, and the specific placement and format requirements depend on whether the software is distributed in packaged or non-packaged form.  Software distributed in a non-packaged form (e.g. electronic download, cloud-based), the UDI must be displayed in an easily readable plain-text format, such as an "about" file or startup screen.

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 13:20
From: Jackie Jaskula
Subject: Our members-only Ask Me Anything session on UDI starts now!

How is UDI handled for non-distributed software. Is it sufficient to include the UDI on the "About" page?

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

When the labeler facility relocates, can US GUDID records be updated to change the address while keeping the same product UDI numbers? Thank you!

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Within GUDID, the address for the labeler is sourced from the DUNs number supplied with the UDI dataset.  Quick review of the triggers for a new UDI does not include a labeler DUNs change or update.  I believe that the labeler would have to update the address associated to the DUNs but may be able to utilize the same UDI.  Each situation is different and can be nuanced so manufacturers should work with their notified bodies to confirm.

The address change could impact other requirements associated with placing the device on the market such as the physical label on the device (if applicable) and the establishment registration of the labeler.

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 13:24
From: Anonymous Member
Subject: Our members-only Ask Me Anything session on UDI starts now!

This message was posted by a user wishing to remain anonymous

When the labeler facility relocates, can US GUDID records be updated to change the address while keeping the same product UDI numbers? Thank you!

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

------------------------------
James Gianoutsos
Founder & CEO
RIMSYS
Pittsburgh PA
United States
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

My understanding (via GS1 documentation) is that if the acquiring company also acquires the GCP of the other company, the UDI would not have to change as the GCP is unchanged (but now owned by the acquiring company). GCPs typically have limited uses (number of UDIs that can be allocated), so one company may have multiple GCPs anyway. Can you comment on this situation as a clarification to the response above? 

Original Message:
Sent: 17-Apr-2024 13:29
From: James Gianoutsos
Subject: Our members-only Ask Me Anything session on UDI starts now!

Question submitted anonymously:

"If there's been a transfer of ownership and the legal manufacturer changes, does that trigger a new UDI-DI for registered devices?"

Our answer:

Where the legal manufacturer changes, the SRN associated with the legal manufacturer will also change. The SRN is submitted as part of the Basic UDI profile of data so a new BUDI will be applicable and need to be associated to those devices subject to the manufacturer change.

A new UDI may need to be applied based on other data that is changed as part of the UDI data. Review of labeling etc. is recommended to understand the delta of information that has changed and to make a final assessment of whether new UDI DI is required.

Specifically, per the MDR/IVDR, a new UDI-DI shall be required whenever a change could lead to misidentification of the device and/or ambiguity in its traceability. Any change to the following UDI database data elements shall require a new UDI-DI:

1) name or trade name

2) device version or model

3) labeled as single-use

4) packaged sterile

5) need for sterilization before use

6) quantity of devices provided in a package

7) critical warnings or contra-indications

------------------------------
James Gianoutsos
Founder & CEO
RIMSYS
Pittsburgh PA
United States

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

When an IVD is a diagnostic test performed in a laboratory (i.e., laboratory developed test in the US) and the product owner has 2 laboratory sites, does each site's results require a separate UDI? For example, as the test itself is not distributed, we will be placing the UDI for the test on the resulting patient report. The result could come from either of our 2 lab locations. Does the patient report for each location require a different UDI even though the test sites have been validated to be equivalent?

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Thanks all of you for joining us at this RegEx AMA, and thanks to Adam, James, and Bruce for joining us and sharing their expertise!

We didn't get to answer every single question that came in, but we hope to come back and answer a few more soon. However, any questions asked now that the event has concluded may not get answered. Thank you for understanding!

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

This message was posted by a user wishing to remain anonymous

Feels like a missed opportunity - there were plenty of questions asked and not many answered.

Original Message:
Sent: 17-Apr-2024 13:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

Thanks all of you for joining us at this RegEx AMA, and thanks to Adam, James, and Bruce for joining us and sharing their expertise!

We didn't get to answer every single question that came in, but we hope to come back and answer a few more soon. However, any questions asked now that the event has concluded may not get answered. Thank you for understanding!

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Hi Ryan,

Please let us know where these answers are posted.  Thank you.

------------------------------
Erin Mazzone
San Jose CA
United States
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Answering an anonymous question we received before this session started:

Which countries have public-access databases? (EU, US, GB, any others?)

ANSWER: No other countries have public access databases at this time. While most countries primarily intend to utilize UDI for regulatory purposes, some information may be accessible to the public (e.g., countries such as Brazil, Australia, Canada).

------------------------------
Bruce McKean
Director of Regulatory
Rimsys Inc.
Pittsburgh, PA
USA
bruce.mckean@rimsys.io
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

China NMPA also creates the searchable database open to public: 国家药品监督管理局医疗器械唯一标识数据库 (nmpa.gov.cn)

------------------------------
Minghua Chen
BD Manager, APAC
Qserve Group (China)
Nanjing
China
------------------------------

Original Message:
Sent: 18-Apr-2024 14:41
From: Bruce McKean
Subject: Our members-only Ask Me Anything session on UDI starts now!

Answering an anonymous question we received before this session started:

Which countries have public-access databases? (EU, US, GB, any others?)

ANSWER: No other countries have public access databases at this time. While most countries primarily intend to utilize UDI for regulatory purposes, some information may be accessible to the public (e.g., countries such as Brazil, Australia, Canada).

------------------------------
Bruce McKean
Director of Regulatory
Rimsys Inc.
Pittsburgh, PA
USA
bruce.mckean@rimsys.io

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

An anonymous question: If a manufacturer produces both diagnostic grade and educational purpose anatomical models for orthopedic surgeries, would the anatomical models created for education and research need a UDI?

My answer:  If the anatomical models created for educational and research purposes are not intended for diagnostic or therapeutic use, they may not require a Unique Device Identifier (UDI). UDIs are typically used for medical devices that are intended for use in diagnosis, treatment, or prevention of disease. However, regulations and requirements can vary by country, so it is recommended to consult with regulatory authorities 

------------------------------
Bruce McKean
Director of Regulatory
Rimsys Inc.
Pittsburgh, PA
USA
bruce.mckean@rimsys.io
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

My answers to an anonymous multi-part question:

What are the important rules/limits on UDI generation and those data inputs required for medical devices in EUDAMED?

ANSWER: You can find the technical documentation for Eudamed here - https://webgate.ec.europa.eu/eudamed-play-help/en/documentation/technical-documentation.html

What is the projected timeline for UDI EUDAMED module to go mandatory?

ANSWER:  The current project timeline based on the transitional guidance is in 2029.  Updates to the regulation that allow the modules of Eudamed to be validated and released separate have been introduced and will likely bring that target date in.  The Eudamed site suggests that the date could be as early as January 2026 for mandatory application.

Will there be UDI information that is publicly accessible?

ANSWER:  There will be UDI information that is publicly available.  Ive not seen a list of those data attributes formally identified by the EC.

I understand the UDI module is not yet mandatory however in a case where you register the required UDI information and you need to re-register due to an original error in the input data or a change in the UDI-DI, will EUDAMED have a function that will allow the manufacturer to make these changes?

ANSWER:  My understanding is that the Eudamed help desk is working with manufacturers on specific submission errors to correct the data in the system.  Im not aware of a formal process within Eudamed where manufacturers can unlock UDI records and make updates to previously submitted data.  Contact the Eudamed help desk if changes to existing records are needed. "

------------------------------
Adam Price
RIMSYS
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Is it still possible to get an answer to my question below (#10)?    Thank you!

------------------------------
Kathie Goodwin RAC
Senior Director, Global Regulatory Affairs, Drug Delivery and Digital Health
Eli Lilly - ENTERPRISE
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------

Answer to question (#10)

Annex VI, Part C, 4.10 in MDR (EU) 2017/745 states, "Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:
(a) any type of direct marking would interfere with the safety or performance of the device;
(b) the device cannot be directly marked because it is not technologically feasible."

I think that EUDAMED will have a field similar to the "Device Subject to Direct Marking (DM), but Excepted: " field in GUDID. MDCG may issue additional guidelines in the future to elaborate on whether or not the manufacturer is expected to submit a stand alone application for exemption. 

------------------------------
Divya Raghavi Nandakumar
Regulatory Specialist
Trimed, Inc
Valencia CA
United States
------------------------------

Original Message:
Sent: 29-Apr-2024 16:26
From: Kathie Goodwin
Subject: Our members-only Ask Me Anything session on UDI starts now!

Is it still possible to get an answer to my question below (#10)?    Thank you!

------------------------------
Kathie Goodwin RAC
Senior Director, Global Regulatory Affairs, Drug Delivery and Digital Health
Eli Lilly - ENTERPRISE
Indianapolis IN
United States

Original Message:
Sent: 17-Apr-2024 12:52
From: Ryan Connors
Subject: Our members-only Ask Me Anything session on UDI starts now!

I'm here with Rimsys experts @James Gianoutsos, @Adam Price, and @Bruce McKean, and they're ready to answer all of your UDI-related questions for the next 30 minutes!

This is Everything You Want to Know About UDI, RAPS members-only Q&A. I've attached some slides to this post that explain a bit more about unique device identification (UDI). I invite you to read them and submit a question! 

------------------------------
Ryan Connors
Social Media and Communications Specialist
RAPS
------------------------------