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eCTD 4.0 & Medical Devices: What's Happening in 2025?
135 Plays2 months ago
Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager. We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices.
- Know what’s coming, when. Check out our eCTD 4.0 implementation timeline
- Be part of the future of publishing. Download Diarmuid’s pilot readiness checklist
- Get prepared. Catch up on the MHRA’s proposals
- Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM
Transcript
Introduction and Host Background
00:00:00
Speaker
Welcome to the Ennovation Podcast, your go-to source for the latest I'm your host, Alice, and I've worked in regulatory operations for eight years. My background is in regulatory information management, and I bring my experience working in large pharmaceutical companies to supporting clients here at Ennov
00:00:31
Speaker
Let's dive in.
Topic Introduction: ECTD 4.0 and MHRA Consultation
00:00:32
Speaker
This month, we're catching up on the latest progress in ECTD 4.0 and an interesting MHRA consultation related to medical devices and in vitro diagnostics. I'm joined by Diarmuid Waide who's a senior RIM consultant specializing in publishing, and Sean Carpenter, who's a product manager specializing in medical devices. Diarmuid Sean, welcome to the podcast.
Dermid Wade on Regulatory Updates and ECTD 4.0 Flexibility
00:00:52
Speaker
Can you introduce yourselves?
00:00:54
Speaker
Well, yeah, um, my name is Diarmuid Waide I'm currently a senior consultant with Ennov My main day-to-day role is focused on looking at regulatory updates, um, offering guidance on publishing standards and answering client queries and questions around such things. Um, in terms of experience before that, I was a publisher for about seven years dealing with global markets, um, US, CU, Asia, pretty much all over. Yeah.
00:01:24
Speaker
Hi, Alice. I'm Sean Carpenter and I work on our RIM product at Enov. I've been with Enov for six years now and I have 25 years experience in life science. And my focus lately has been on medical devices and building out our RIM core model to support medical devices and in vitro diagnostics.
00:01:53
Speaker
So Diarmuid I know you've been keeping a really close eye on ECTD 4.0. Can we start at the beginning? What makes ECTD 4.0 so different from current ECTD standards? Yeah, the key differentiator between the old ECTD standards and the ECTD 4.0 must be the flexibility aspect. The features that we've seen that really show this off are the control vocabularies, the standard of fine keywords and the new lifecycle operations.
00:02:19
Speaker
I'll start with controlled vocabularies. They allow for the health authorities to easily update predefined lists that are available to the user. um It kind of works in a plug and play model where the agency say will release the list and you should be able to import it into the publishing solution with relative ease, um hopefully shortening the time between them releasing their predefined lists and then you actually see it in your end system.
00:02:44
Speaker
for the sender to defined keywords. This is one of my favorite features. um And I'll be game changing in terms of ACD organization. It works similarly to how the old metadata fields would work, where the user would manually enter values such as a drug substance, drug manufacture. But what this does differently is it assigns a code to the keyword. For instance, a lot of companies perform supply chain optimization over the course of a drug's life cycle. And this can result in having to change the drug manufacturer's name. This happened to me a couple of times over the years. and So what you would have to do
00:03:19
Speaker
is take your um module free and basically resubmit a lot of it. So you predefined that manufacturer and then you have to redefine it as the new one and they're basically two different buckets and you'll have to move your documents between them. It's very painful, very tedious. It looks messy. I don't like it. With this new system, all you have to do is just change the descriptor and that's it. Your folder is now relevant for the new manufacturing site. It would save so much time, so much energy, I wish I had it five years ago. ah For lifecycle operations also, we have the one-to-many and many-to-one.
Lifecycle Operations in ECTD 4.0
00:03:59
Speaker
These operations will be great in maintaining a clean dosser as well as having the continuity of the lifecycle for the documents. ah For example, things like analytical procedures,
00:04:11
Speaker
Over the course of a product lifecycle, the offers are probably going to change in CMC, and they have different ways of doing it. Some will submit their analytical procedures granularly. Some will submit them as a single document. And what happens to you as you're left with the decision is what document do I replace? Because if you go from 14 documents to one document, you have to choose one to replace and the rest to delete.
00:04:34
Speaker
um But with this new system, that's all done away with. You can replace all 14 documents with this single combined document, and also the other way, which is massive that that helps us so much. It'll be so good once ah whatsever everyone gets their hands on it. It sounds fantastic. It sounds much cleaner, which would be great. Yeah, 100%. Yeah, it's so much better. So what progress have we seen in 2024?
ECTD 4.0 Live Submissions and Industry Preparation
00:04:58
Speaker
twenty four um Yeah, it was definitely a big year for ECE 4.0 with the first live submissions going to the FDA. As we know, the regulatory side of pharmaceuticals that can be really fast moving at times, but we find with the adoption of new tools and standards, people tend to be risk averse and somewhat cautious.
00:05:18
Speaker
um But with the US having their pilots in 2023 and accepting live submissions in 2024, it's really marking a turning point now. We're all hesitant to change, but the things in ECD 4.0 will certainly be worth changing for. As a publisher myself working with the technology for the pretty much every day for the past year, it's really interesting to see how the new features that I would have seen in slide decks maybe five years ago are actually being manifested in the product.
00:05:46
Speaker
and how the teams are working together to try and implement these changes being one of the first in the industry to do it. I've said before how it's really important now that companies start to think that they will be submitting ECD-4 sooner rather than later.
00:06:02
Speaker
Yeah, it definitely sounds like we're reaching that tipping point. And I think you're right. With regulatory, it's often both very slow and very fast. yeah You have that really long buildup, but once things start to move, they can change quite quickly. And you really need to be ready for that, don't you? Yeah, absolutely. Well, it sounds like 2025 is going to be a really exciting year.
Global Pilots and Industry Focus on ECTD 4.0
00:06:20
Speaker
What's in store?
00:06:22
Speaker
um If I said it just there a minute ago, but it's really going to be a big change of point, you're going to have to start thinking about EZ E4.0. We've currently got pilots coming up for the EU, Switzerland, Brazil, Canada, Australia. It's truly going to be one of the major talking points of the industry and the focus of so many teams. In regards to us, we're currently invited to participate in the EU pilot.
00:06:47
Speaker
and we're currently building out that functionality and plan to submit a test sequence very, very soon. We're also working tirelessly to improve our publishing tool to ensure it's the smoothest submission process for publishers new to ECD 4.0. And if anyone listening thinks they're maybe in the position where their company could potentially need to start sub submitting 4.0, they should probably reach out to their vendor sooner rather than later to ensure that they'll be able to facilitate that.
00:07:15
Speaker
Yeah, you definitely need to make sure your tools are ready for those changes, don't you? Absolutely. So I know there's an EU pilot that's coming up soon. How can companies get ready to participate in these pilots?
00:07:27
Speaker
It's a good question. That's something that's often overlooked. Everyone's very quickly thinking, oh, I need to participate in this pilot. I better reach out to my health before I immediately. But first, you really have to go and speak to your tool vendor and let them know. Once they've agreed that they'll be able to support you in the pilot, then you'll have to internally prepare and ensure that you'll have the appropriate resources.
00:07:50
Speaker
to participate in the pilot once it comes around. Then once that happens, you probably want to reach out to the health report and declare interest. If it hasn't already been published on the website or in the socials, I recently offered a ECDD 4.0 pilot checklist. um I'd have have a quick look at that and you could probably use that as a guide as to what you need in order to be ready for a pilot.
00:08:17
Speaker
Thank you so much, Damod. I think we'll be talking again about ECTD 4.0 throughout the year, and I'm really looking forward to finding out more. Definitely.
00:08:35
Speaker
Hey, Sean. Thanks for joining us. I hear the MHRA have just closed a consultation regarding medical devices and in vitro diagnostics, and a big part of that was an international reliance process.
International Reliance in Medical Device Regulation
00:08:46
Speaker
Is that correct?
00:08:47
Speaker
It is correct. um And importantly, there are other countries who have implemented similar international reliance frameworks. um For example, Canada has a mutual recognition agreement with the EU for medical devices, which allows devices certified in one jurisdiction to be recognized by the other. And it's facilitated market access and reduced regulatory duplication.
00:09:17
Speaker
um Australia uses the same thing with the TGA, especially for devices that have to go through rigorous assessments by comparable regulators. It's helped Australia maintain a balance between safety and innovation, and you know it's gotten positive feedback from both regulators and industry. And then Singapore and Thailand have also had a pilot for Reliance Pathways.
00:09:45
Speaker
which significantly shorten their approval times, ah showing that you know when you can implement these sorts of things with trusting and communication between regulatory bodies, the system can work efficiently.
00:10:01
Speaker
um It doesn't always work as efficiently as as we had hoped. One of the key examples that I point out is between the US FDA and and Brazil's regulatory authorities.
00:10:14
Speaker
when in 2012 Brazil suspended its reliance on FDA approvals for drugs. It cited concerns over safety and the adequacy of the FDA's assessments for the Brazilian market context, showing that you really have to have a trust that you're getting a tailored assessment and that you're getting the national and ethnic concerns that you have for your particular country met by the framework that you're using to approve these products. Absolutely. I guess relying on another country only works when you feel confident in their procedures.
Harmonizing the Universal Device Identifier (UDI)
00:10:54
Speaker
But could this concept of international reliance encourage the harmonized use of the UDI across many markets? No, it it absolutely can. And UDI, when it was first rolled out, was intended as
00:11:09
Speaker
an identifier that could be used universally across all markets ah for a single product. And in reality, it didn't meet that expectation that each market would basically assign its own ah quote unquote unique identifier. And that led to additional work and additional cross-referencing that's needed when you have a device in one market versus another. So.
00:11:37
Speaker
In the case where we're adopting similar regulatory burdens across multiple markets, ah that really does simplify when you're using a single identifier for your product. ah It helps to align the product that you got approved in one market with the product that you're trying to sell in another.
00:12:03
Speaker
um It would also enhance what I think was the original intent of the UDI for global tracking and safety, ah where when you have an adverse event with a device in one market, it's clear and easy to identify the other markets where that same device is being sold. So it it would take some effort to harmonize all of those items and would take additional ah burden on the manufacturer to ensure that they're they're using a singular unique identifier for each device, but I think it could play out some significant benefits. It certainly sounds that way. I see the consultation also covered in vitro diagnostic regulations.
UKCA Markings and Regulatory Challenges
00:12:49
Speaker
One thing I thought was interesting was the proposed changes to the markings required on both devices and in vitro diagnostics that have been licensed through the UKCA pathway.
00:12:58
Speaker
The MHRA is suggesting they could eliminate the UKCA markings, right? Would that help align with the IVDR even further? No, it it absolutely does. um it It makes some changes that would basically bring the UK in alignment with the IVDR, especially for the classification of the devices themselves. ah This could certainly help streamline the market access.
00:13:25
Speaker
The UK is a much smaller market than the overall EU market. But if you're applying a regulatory burden for a larger market, it makes sense that you could reuse that for the smaller one being the UK. And it would also, we touched on safety a little bit and adverse event reporting, but ah having more stringent requirements on your devices to meet IVDR ah would certainly also bring those same safety improvements to the UK. It sounds like a really positive shift, but I imagine there are also some challenges and some risks associated there. ah There certainly are because the IVDR burden is higher than what the previous UKCA requirements were set at. So that means some devices which were previously self certified
00:14:23
Speaker
will now require ah notified body approval in order to get those onto market. And this is not unique to the UKCA. And those of us who have been following the IVDD to IVDR transition, we know that a lot of previously self-certified devices are now going to have to go through a more rigorous notified body approval.
00:14:50
Speaker
so It does pose an increased regulatory burden for these manufacturers. I would also cite that it could possibly have innovation concerns as well. I think that we've seen with the advent of IVDR that a lot of manufacturers are opting to move to a US first implementation because the regulatory burden is lower there.
00:15:19
Speaker
and This could certainly happen here, although I think with the tying of the UK market and the EU market, I still think there's a significant benefit to at least aligning the requirements for the standards ah to the IVDR. And I think that will encourage the market as a whole to embrace those regulations. Sean, it's really interesting. And I think it's going to be interesting to see how this evolves as well.
00:15:50
Speaker
Indeed. So again, I'm sure we'll be discussing it again. Yeah. Thank you. Dermot, Sean, thanks for joining me. Dermot and Sean have created some great resources and they're live on nov.com now. Check out Dermot's guide to preparing for ECTD 4.0 pilots, complete with a fantastic checklist to make sure that you get the most out of your pilot experience. Sean has written a great summary of that MHRA consultation with everything you need to know about what the MHRA are proposing to change.
00:16:20
Speaker
There are links to all those resources and more in the description. Thanks for tuning into the anov Innovation Podcast. At Enove, we help over 450 life sciences companies streamline compliance in heart sufficiency and achieve their regulatory goals