Webinar Recording and Full Transcript - What You Need to Know About Article 10a

How Can Manufacturers Address Article 10a Requirements and Manage Supply Chain Challenges?

Speakers: Bassil Akra, Erik Vollebregt, and Lawrence Yeh 

[Download the Complete Guide to Article 10a Compliance and Mastery]

Index

[Download Slides]

Introductions and Housekeeping (00:00 - 05:00)

Article 10A Overview (05:01 - 15:00)

•  Applies to all MDR and IVDR devices, except custom-made devices

•  Requires communication of anticipated product interruptions or discontinuations

•  Focuses on cases that could result in serious harm to patients or public health

•  Manufacturer must inform competent authority, importers, distributors, health institutions, and healthcare professionals

•  Manufacturer Information Form (MDCG2024-16) standardizes reporting

Implementation Challenges (15:01 - 30:00)

•  Manufacturers need to identify triggers for supply interruptions

•  Six-month advance notice required, except in exceptional circumstances

•  Challenges in predicting and communicating business decisions

•  Potential competitive risks in early disclosure of supply issues

•  Importance of updating agreements with economic operators

Legal and Business Considerations (30:01 - 45:00)

•  Risk of legal consequences from early disclosure (e.g., anticipatory breach)

•  Confidentiality concerns with information shared with authorities

•  Potential for Freedom of Information requests to reveal strategic information

•  Need for careful communication to avoid market rumors

•  Importance of evaluating device criticality in healthcare system

Health System Impact (45:01 - 55:00)

•  Focus on devices critical to healthcare system continuity

•  Consideration of market share and ability of competitors to meet demand

•  Post-market surveillance obligation to monitor competitive landscape

•  Notified bodies expected to assess Article 10A implementation in audits

•  Importance of documented evidence in quality management system

Risk Assessment and Stock Management (55:01 - 01:01:23)

•  Need for risk assessment considering multiple factors (e.g., market share, training requirements)
•  Consideration of bridging stock in risk assessment
•  No explicit requirement to maintain six months of stock
•  Importance of having a procedure in place ASAP

Transcript

Lawrence Yeh - 02:28
Today's webinar is called “What You Need to Know about Article 10a before January 10, 2025,” and it's intended for economic operators under the MDR and IVDR, including manufacturers, authorized representatives, importers, and distributors.

What you'll see here today includes information from the Regulation EU 2024-1860, which was published in the Official Journal on the 9th of July, 2024; and some key points from revision 1 of the Q&A document, originally published by the EU Commission in October, 2024 and revised just this month in December, 2024.

This webinar will feature the opinions and interpretations of myself and the two guest speakers, so please take note of that as a disclaimer.

On today's agenda, we will walk through your new and upcoming obligations described in Article 10a, including how to interpret some of the gray areas.

I will present some ideas about what you need to have done yesterday, given the fast-approaching date of January 10th, 2025.

And then we will have a panel discussion with our two guest speakers, Dr. Bassil Akra and Erik Vollebregt.

After that, we will have some time for some questions that were submitted before the event, and we can take some questions from the live audience, as Sean has already mentioned.

So, let's start with a diagram to help visualize things.

At the core of Article 10a is a communication chain.

You can see each stakeholder must inform the next stakeholder of anticipated, that is reasonably foreseeable, product interruptions or discontinuations.

And specifically, we're talking about those that could result in serious harm to patients or public health.

So you see, the manufacturer informs the competent authority who informs other competent authorities and the European Commission.

Depending on how the manufacturer places the devices on the market, the manufacturer directly informs the health institutions and healthcare professionals to whom they supply devices, or the manufacturer informs the importers and distributors, who then pass on the message.

We will come back to this diagram shortly, but in a nutshell, this is the key aspect of Article 10a, this cascading communication.

In essence, it is a mechanism allowing the member states to identify product shortages.

That was the intention of the lawmakers, knowing that they have regulatory bottlenecks, to somehow become aware of device shortages early enough to be able to react.

They don't need to know all product shortages, only some.

So let's talk about the scope and other details.

Article 10a applies to all devices under the MDR and IVDR, except custom-made devices, that have been placed on the union market and this includes all legacy devices.

It’s very important to understand what is in scope here.

But then, for all such devices, Article 10a requires certain actions under the following conditions:

• Number One: a temporary inability or unwillingness - you can use 60-plus days as a guideline, but this is not a strict rule - and that this supply interruption would result in serious harm to patients with public health.
• Number Two: There is a permanent cessation, where the manufacturer will permanently stop placing a device on the market, and, again, that this continuation could result in serious harm.

So, right away, you can see there are some nuances to these conditions that we must explore clearly.

Let's dive deeper. Let's talk about the roles and responsibilities.

So, who is performing this initial communication under Article 10a?

It's the manufacturer of devices placed on the unit market, including legacy devices, that are responsible for the initial communication.

They need to have a system in place to identify when either of those two conditions we just talked about has been triggered.

This will involve some communication within the organization and with external stakeholders like suppliers who are not pictured in this diagram.

Now, who is receiving the communication?

First, there is the competent authority in the member state where the manufacturer is located. If the manufacturer is outside the EU, of course, it is the competent authority where the authorized representative is located.

Other recipients of the communication include all relevant importers and distributors. We have a dotted line here in case they're not used.

And then there are the health institutions, which are defined as organizations with the primary purpose of caring for or providing treatment to patients or promoting public health. This comes from the MDR itself.

And healthcare professionals who are impacted by the supply interruption or discontinuation.

And importers, if any, will inform all of their impacted distributors and similarly, those distributors will then inform all the downstream health institutions and healthcare professionals.

Now, the manufacturer is the source of this information being passed on.

And the Q&A document published by the EU Commission clarifies that the stakeholders should not be making any changes to this information. 

If there are any amendments or follow-ups, they should originate from the manufacturer.

Now, what is in this notification or information that's being communicated?

Well, just recently, the manufacturer information form was published to standardize this activity: MDCG 2024-16. If you are unaware that it was published, I suggest you run to your favorite internet search engine and type it in MDCG 2024-16. On this form, aside from the usual administrative information, such as manufacturer and device identification, you need to categorize the interruption or discontinuation and identify if it was a regulatory, supply chain, or manufacturing issue or something else altogether.

You need to identify the reasons why this might present a risk of serious harm, such as the device being a life-sustaining or life-saving device or accessory; a device intended for vulnerable populations, such as pediatric or geriatric patients; whether or not the lack of the device on the market would prevent patients from accessing treatment.

While the categories on the form can provide some hints or clues about how to interpret the risk associated with this supply interruption or discontinuation, there is also another category, so the options on the form are not a complete or exhaustive list.

There are also many sections on the document that are marked as voluntary, so please do read the form carefully and familiarize yourself with the contents.

And finally, there is also an annex document to NDCG 2024-16. This actually provides a table for identifying all the devices in the scope of the supply interruption or discontinuation.

Now, what about the timing of the communication? 

If the issue is reasonably foreseeable, the notification must occur at least 6 months prior to the anticipated supply interruption or discontinuation. 

There are exceptional circumstances, which are defined as unforeseen situations where the manufacturer is unable to anticipate this supply interruption or discontinuation.

Some examples listed include natural disasters, a sudden inability to obtain raw materials or components, and economic or financial circumstances.

These are situations where the manufacturer must simply inform the stakeholders without undue delay.

And similarly, the passing on of information from, let's say, importers and distributors along the supply chain, must also occur without undue delay.

And remember, it's not expected that this information is amended or edited in any way, so they don't have an excuse to delay the communication.

The key challenge here is how quickly they can identify the downstream supply chain.

From my experience auditing various economic operators, this process will test the ability of some importers and distributors to quickly identify all the relevant customers of a particular device.

Now, in terms of the start of applicability, the regulation itself is already in effect, the overall regulation to which amendments were made.

The reporting requirement for 10a starts as of January 10th, 2025. 

So, this means that if, on January 9th, you realize that there may be a supply interruption discontinuation, technically, this regulation does not apply.

If you've already ceased supplying for unrelated reasons, then those stakeholders do not necessarily need to be informed as a result of this.

This point is clarified in the Q&A under number four.

What about the serious harm aspect?

So, the Q&A clarifies that we're talking about cases where, let's say, a particular diagnosis method or patient therapy is unavailable, and the healthcare professional cannot deliver a specific medical treatment.

Or situations where a serious injury occurs, or there's a significant probability of it occurring - imminent risk of death, serious deterioration of patient health, as defined in MDCG 2020-03. 

Those are the things you want to consider.

You can also get some clues from the manufacturer information form. 

Earlier, I mentioned that the categories listed could suggest some situations, such as a device used in a serious acute or chronic pathology.

Then there's the question of what is “reasonably foreseeable.”

So, manufacturers need to understand the triggers that qualify as anticipating the interruption or discontinuation. It's based on their own internal analysis and confirmation that there will be an interruption or discontinuation. For whatever reason, it could be supply chain activities, it could be their own capabilities or limitations, or decisions due to business, economic, or financial reasons.

I encourage everyone to read through the Q&A document very carefully. It talks about how the manufacturer does not need to consider whether other devices from other manufacturers can be used or, necessarily, the stock levels.

Or when they don't need to conduct a comprehensive market analysis.

In other words, they need to focus on their own portion of the supply chain, the information that is available to them, between them and their direct importers, distributors, and customers.

This point is clarified in Q&A in number 7. Moreover, I just want to emphasize the importance of knowing what devices are in scope.

It's all devices on the market, including legacy devices, excluding custom-made ones, and you want to know all the possible reasons for supply interruption or discontinuation, such as not having a valid certificate or deciding not to pursue certification anymore, device performance issues, difficulties in obtaining components necessary for manufacturing, or other disruptions in your supply chain.

All of those need to be considered. 

So, what should you focus on right now?

It is mid-December, and everyone's getting ready for the holidays. What do you need to do?

Number one: for the manufacturers, ensure you understand the triggers to look out for. These triggers indicate when you should proactively perform an assessment. Consider regulatory issues like no longer fulfilling the transition requirements for legacy devices under Article 120 of the MDR or 110 of the IVDR. Consider business decisions to no longer pursue certification. It's not just about your supply chain issues with components and raw materials. And understand situations that are not triggers. 

For example, can you replace the device with a successor device with a similar intended purpose? Do you have enough stockpiled devices to fulfill any demand so that you don't have an interruption longer than plus or minus 60 days?

The Q&A includes a scenario where the manufacturer can receive confirmation from health institutions that this would not necessarily provide any harm. So figure out ways of being able to establish this communication.

Number two: once you understand this range of possibilities, think about how you will implement it. Find a way to proactively identify things with a six-month horizon. Look into your monitoring activities. Do you have good relationships with your suppliers? If there was an issue, would you know? Especially for sole source parts. What about communications with product marketing teams or top management? How will you find out that there's a pending decision to discontinue a product? Who's going to perform the assessment internally? And how will they get the information about whether or not there's a suitable successor device or alternative solution? 

Make sure you can communicate with all the other stakeholders. Can you communicate with the health institutions? Can you communicate with your importers and distributors? You can consult with physicians, societies, associations, etc. to gather information, but just remember that you're not looking at it on individual patient cases but for the entire population for which the device is intended. Again, you can look to Q&A number 9 for more guidance on this topic. 

After this, it's time to revisit your procedures and agreements. Look to your QMS. Do your agreements with your economic operators allow you to have this communication?
Are the triggers going to be in place? Do you know who to contact when there's something wrong? We've got the manufacturer information form released, but the other thing that they promised was the decision tree diagram. So, look out for this publication, which should help with the decision-making process about assessing the risk and whether or not to start the domino effect.
Number three: look out for additional information from the competent authorities. They may release other information that provides specific guidance applicable to their regions on this topic.

Now, before we turn it over to our panel discussion, we will do a very quick poll from the audience. So I'll throw it over to Sean up there. He's got it on the screen. You guys should be able to plug this in. We'd appreciate any input. And in the meantime, we will jump over to our panel discussion.

So, the first question is for both of you:

January 10 is just around the corner. We've just seen the release of the manufacturer information form. Do you have any rumors or inside knowledge about when manufacturers can expect the decision tree diagram to be published?

Erik Vollebregt - 21:25
The decision tree I have absolutely no idea. Do you, Bassil?

Bassil Akra - 21:31
No, actually, I mean, what we can expect is that the commission and the member states are working on preparing these documents, and we will get surprises over Christmas potentially because at the end of the year, they are working hard to get all that is needed.

But I would not be surprised that we'll get the decision tree after January 10 like we did in the past for other obligations.

I do not recommend people to wait for something where we don't know when the date is, Lawrence.

I think you did a good presentation where you explained to us what we need to do, and there is one bullet point which you added, which is very valuable. You mentioned we need to prepare; we need to build our process; we need to drain our resources; and we need to work on our agreement.

The decision tree might help us perhaps do the micro adoption of what we have built, but first of all, we need to build the foundation for the system, which is expected to be ready by the 10th of January.

Erik Vollebregt - 22:09
Yeah, there's nothing that prevents you also from making your own decisions. This is what you could also do as part of preparing your procedures.

So normally, if you prepare your procedures, I mean, I would always science the shit out of it, as they say in “The Martian.” And that means that you try to understand how it works logically. And if you have an idea about that, you can put it in a flow chart. And then compare it to the flow chart that, in the end, is published. And the good part is that, if it's the commission, the Q&A is fairly detailed, although not on all points, which would basically allow you to make a pretty good flow chart already. I made mine, and I think it's already pretty detailed, but we can always compare.

Bassil Akra - 23:28
Yeah, and you know you are mentioning something very important, Erik. The reality is it is the manufacturer's obligation to meet the law. All of these guidances are actually recipes on how you can actually address the requirement, but the recipes are not stipulated word by word in the law. The lawmaker told us that this is what we need to have. We need to have a system in place to report potential interruptions of devices not being available on the market that are essential for the healthcare system, and the guidance will help us understand what is written there.

And even if we get the decision tree, it will potentially not address all cases.
It makes sense that you look to it by yourself and build a system where you can live with it, and you can show that it's compliant with what the law is saying to us.

Erik Vollebregt - 23:17
Actually, you might even influence the decision tree in the end by having a better one yourself,  because what you always see invariably with this kind of legislation is that at the beginning, notified bodies and even member states, if they take a look in your kitchen, they are learning as much as you are, and they will typically start by looking at things like that and learning themselves.

So actually, it's very beneficial to do your homework on these things and show that you also have thought about how to make this work, because I think there's one thing really important about this commission Q&A, and I think Bassil also expressed that already - it is very much built on the thinking that it is the manufacturer's prerogative to make this decision based on the information that they have.

So, that also underlines that you can sit and wait until the commission may deliver a flowchart in the end, but then by that time, you could already have implemented procedures yourself that would also be okay or would fit in this. 

So waiting, especially in this case, I don't think is a very good idea.

Bassil Akra - 25:49
I think Lawrence gave them a recipe already, to be honest, because he gave a good presentation with bullet points and explanations, and he referenced the various questions and answers provided by the Commission, which can help them actually look to those key points and prepare themself. Because in the end, the notified body will also look to your process to see if your process is suitable to address the requirement. They will not look at whether you are actually applying a decision tree from the commission. They want to know how you're going to do it, and you need to show them your methodology.

The guidance helps us understand what the current understanding of a requirement is, and this will allow us to improve, but I think you need to work it for yourself because if not, you will create for your system what you can't live with as well.

Erik Vollebregt - 26:39
And guidance is guidance; it also always gives you room to maneuver.

Lawrence Yeh - 26:46
And in line with this whole question about how you decide when to actually make a report, the Q&A talks about what an exceptional circumstance is and defines it as, here I quote, “when a manufacturer is unable to anticipate or confirm a supply interruptions continuation at least six months in advance, for instance, a natural disaster, an interruption due to a sudden inability to obtain raw materials or components, or a discontinuation due to unexpected circumstances, including an economic or financial nature.”

So question for you, Erik, I imagine a situation where a manufacturer doesn't think they need to discontinue a product. Maybe they think their financial situation will change, but then suddenly, the board makes a decision to shut down the product line. Is there some legal grey area here? How does one argue that the manufacturer should have anticipated that discontinuation?

Erik Vollebregt - 27:49
They should have is, of course, very much a moral way to look at it. Basically, this is about information that, in the end, is supposed to help competent authorities and health institutions take mitigating measures. Now, the good part is that the Q&A says, and also the legal text, by the way, both say there can be circumstances in which, as a manufacturer, you do not have a six-month horizon on what's going to happen. Like, for example, your regulatory department makes a mistake with respect to your legacy device certificate because they merged the manufacturer into another legal entity, and then the manufacturer is gone, and your certificate is gone, and suddenly, you can't place these products on the market anymore. It happens. And it's avoidable, but it happens.

And that means that this is something you could reasonably foresee. That's an internal circumstance that you do not have a six-month horizon on, right? 

And the same, for example, with external suppliers. Typically, if they have a critical supplier of a particular raw material or a component, they go bankrupt. Or what also happens if it's a critical supplier? It might be that their management decides, if we have a contract for supply with you, that you're a medical device company. 

We also have to submit to unannounced audits. We don't like that very much.

We terminate the supply agreement, and you cannot switch to another supplier in time. This is also something that you usually may not have a six-month horizon for.

So that's why the guidance and also the legal provision always gives you room to work with external circumstances by saying, we would like you to report at the six-month horizon, but if you can't, then report as soon as you know - that is basically the rule.

And of course, they've written it down in a bit of a stern way to make it to incentivize companies to try and meet the six months. So, basically, you need a justification if you don't have one, but if there is a justification, then a few months is better than no months, for example.

Bassil Akra - 30:39
Yeah, Erik, what you just mentioned makes full sense, and we should remember the reason for this and what they are trying to achieve with that.

So there is no push here than having every single case reported at six months.

The intention is actually to protect the healthcare system. The intention is to protect the healthcare system from systematic interruption of the availability of products, and this is what they are looking for. There will always be cases that are borderline where you wouldn't be able to report on time. But this is, for you also as a manufacturer, a critical case, because, in fact, what Erik was describing isn't actually a happy day for the manufacturer. Because when they get such a contractual agreement cancellation, it's a disaster for them anyhow, because they suddenly cannot manufacture or place the device on the market.  So even that manufacturer is in bigger trouble than actually talking about the interruption because they’re not themselves intending to do that, and it happens.

And the lawmakers wanted to make us actually protect the patients, protect the healthcare system in Europe, and they said we want to have that information. And it doesn't need to be seen as a negative impact on the manufacturer because, in some circumstances, the authorities will support manufacturers having perhaps, in a case where a certificate is not available anymore, a derogation, a special release support them actually being able to get the device on the market. We should look at it in a way where it could be positive also for some manufacturers to have such a system.

Yes, it is an additional burden, but it is intended to protect the healthcare system, and you will not be punished if you don't report every single case at six months advance notice. You will have cases where you have a surprise. This is where they are telling you to build your system for the typical cases and have a system for unknown cases where you can be surprised, but tell us about this. Because we don't want to punish you for that; we want to get the awareness and work with you and others to make sure that the healthcare system continuity is assured.

Lawrence Yeh - 33:01
The next question is for Bassil:

In your experience as a consultant and a notified body auditor, do you think manufacturers generally have the ability to forecast six months in advance?

What are some common areas of weakness that manufacturers should consider?

Bassil Akra - 33:13
I think we discussed this already multiple times. Do they have the ability? Not every manufacturer has sufficient resources to address additional obligations.

I think we were talking about resource limitations for many years, and it's getting more and more, more and more obligations. Are they able to build a system for this?

Yes, they can; every manufacturer can build a system. But we should not forget that manufacturers are not always 20,000-employee manufacturers.

And we should also remember that at the small ones, they might be overloaded with such a task. Now, can they do it?

I mean, Having a system like this, theoretically, it's doable.

But in reality, we are talking about actually setting expectations or predicting what's gonna happen in the future. And who's from us can predict what's gonna happen tomorrow? We can't.

So I think of the typical case where it is business decisions, but does everyone in the business know about actual future decisions on, perhaps, closure of a site?

Some manufacturers and some management might not want to know or to communicate internally about decisions like that very early because this can put them in a competitive limitation, which they want to avoid. This is why they keep it to the last moment.

Now, by getting to this obligation, they are actually getting an expectation that management cannot actually take business decisions anymore freely, because they are limited to communicating that and predicting that and telling the people about what they want to do, which they don't want to do.

And we are not talking always about high-risk devices; we are also talking about devices that might be necessary to support other devices.

And there are a lot of cases that Erik and you elaborated a bit about. Setting a system for a standard case would be potentially possible, but setting a system that addresses business decisions, the supply chain, and the various critical impacts that might lead to such a limitation or interruption in the market will be tough even for the biggest manufacturer. Because it's not just about resources; it's about how much information I have to be able to make such a prediction. And if I predict and communicate that I might have in six months an interruption.

And this gets the awareness of my competition. I might kill my market as well because my competition will get that awareness, and they will start building the stock because we saw it already in many examples, and Erik as well, and others saw it, by authorities contacting manufacturers saying we have in our region some limitation with regard to devices, and those manufacturers are not able to deliver a product. Are you able to provide us with these products because we need them?

And this is leading to a big impact on your ability to have your market share again.

If you communicate something where you are not sure about it, it might have an impact on your market share and your business continuity as a manufacturer because you don’t want it to be risk-creating, but then you create it for yourself a business risk.

Lawrence Yeh - 36:31
That's a very interesting point about how it causes this conflict where they have to decide which obligation we're going to fulfill first. Are we going to perform the early notification, or are we going to have to change our decision?

Bassil Akra - 36:47
Yeah, you never know, because even what you predict six months in advance might not be reality, but it could be also more than that. And all of these predictions are always big assumptions. Therefore, it requires us to build a system where we have very good due diligence early in that step to look into whether it will happen or not. You have cases where it doesn't work because suddenly there is an earthquake, something got damaged, the whole of manufacturing, you cannot build it in a six month period again. And if there is one single supplier, then you are in trouble.

The same case as Erik was mentioned. If I had a supplier who said, ‘I don't want to sign an agreement with you,’ and you are dependent on that single supplier, finding an alternative will not be easy.

So, all of these things might take a lot of time - especially what you mentioned in your presentation of the agreement piece. You know, even if you find someone, sometimes an agreement piece takes longer than a year to get to both an agreement and an alignment which stipulates the obligation and the expectation from both sides.

Yes, and the audits I've done, yeah there are certainly that is a common weak area, for sure,  those agreements with economic operators, and you're absolutely right. It can take a lot of time to get the agreements set up, especially if the manufacturer is maybe a smaller player, let's say, and it's a very large importer or large supplier, absolutely, that is huge. I think Erik can tell you a lot about this kind of situation where you need to look also at what you’re communicating to the authority because you’re sharing information that can have a big impact on me as an organization, and legal review should also be done to protect the business from unnecessary harm, on top of all that we are doing now - trying to protect the patient. But there is an impact on my availability as a manufacturer later on, because my market share will be damaged due to very early communication, which might not be a reality.

Erik Vollebregt - 38:51
Yeah, this is a good one because there is so much risk for damaging your competitive position in the market. For example, one of the things is what kind of information you are going to supply, because if you look at the guidance, there are two groups that you should provide information to, competent authority and economic operators.

There is a form that you need to provide to the competent authority, But there is no form for information that you should provide to economic operators.

And it is also very unclear in the Q&A, basically, there's zero detail on this, what information specifically you should provide to economic operators.

Now, this is a good thing and a bad thing, because, especially for economic operators, actually, it happens quite a lot that even competitors distribute each other's products.

So you would, and if you look at the kind of information that is asked in the reporting form for the competent authority, there can be very strategic information in there that you do not want your competitors to have.

So yeah, what you should definitely avoid as a company is to just send your economic operators the same form as you would send to the competent authorities.

I mean, you can, but it might not be smart. 

Then the question is, what are you going to send them? So you need to have made a good decision on that.

Why is it also very important?

This also goes to the very, very good point that Bassil made just now about timing. Distribution agreements in the supply chain are all about continuity. So the distributor forecasts, and you supply. And if the distributor doesn't forecast or doesn't meet targets, or you as a manufacturer are unable to supply, or you don't meet the demands of the distributor, there may be a default under the agreement.

And depending on what you agree to in the agreement or depending on what national law allows, there may even be a ground for the distributor to claim a so-called anticipatory breach in their distribution agreement if you have to inform them, hey, I might not be able to supply.

So, it might be that this gives legal grounds for the distributors to say, hey, guys, you are in default under the distribution agreement, we want damages, replacement products from another company, and we terminate the distribution agreement, all that kind of stuff. 

Same with situations where, let's say, for example, you have a distributor that has a tender agreement with the customer, or you, as a manufacturer, have a tender agreement with the health institution directly. Tender agreements are usually not very negotiated. So as soon as you tell the health institution I might not be able to supply, there can be all kinds of draconic legal consequences.

So you really need to think about this and also map for your supply chain, like what will it mean if we send this cascade of information into the supply chain? The Commission probably thought, oh, it's easy, we will just make these people tell each other.

But it also means that you get all kinds of legal effects propagating in the supply chain.
Then there's also the matter of what you will tell the authorities exactly because although the Q&A says that the information provided in the form to the competent authorities should be confidential, if you look in Article 109 MDR and the corresponding provision in the IVDR, it says this information is confidential subject to national provisions on freedom of information.

So that means that if you have a local competent authority that is actually pretty, let's say, liberal in the scope of the Freedom of Information Act, they may still just give, like, I don't know, maybe not 100% of the form, but they may give you 80% of the form.

So what I expect is that we will get quite an interesting sport of trying to figure out what exactly the nature of the supply restrictions of competitors is by means of freedom of information requests.

And if you do this with the Dutch authorities, for example, we litigate a lot against them. Or provision of vigilance reporting form information to parties that are preparing product liability litigation. I am amazed by the level of detail that the authorities are willing to disclose, so you also need to think about that actually.

Bassil Akra - 44:25
It's a very good point, because what we need to consider here when we look into all of this information and sharing of information is that the supply when you are sharing information goes up to the physicians as well as to the hospitals, so you are sharing information you are telling about the potential interruption of product availability, and those reports, if you over-report, you might create rumors on the market, whereas there is nothing, you are just trying to meet the requirement, you might create rumors that people, physicians, distributors, importers, they start telling this manufacturer is in trouble - they always have interruptions, or potential interruptions, or this manufacturer might be closing because they don't want to deliver any more products.
So the message provided should be very clear, and you should be very careful about setting your system in such a way that it is just for the relevant devices because I hear a lot of people saying I have a class 1, I have a class 2A, I have a class 2B, I have a class 3 implantable, do I need to report?

You need to look at your device, and its characteristics, and it can be in any class.

What’s important is whether an interruption of such a device is going to impact the healthcare system by causing a situation which is critical? So you need to look to the serious impact on the healthcare system. 

And it's not about actually a syringe supply. But if you are the only syringe supplier on the market, then we cannot inject any drug anymore. Then it is, but if you are actually the number 150 supplier, you might not be that critical, and this is where you need to look into the situation. You build your system so you have an evaluation you have, like you said, Lawrence, before, how can I set my system? Can I set it in the right way? 

You need to understand what is relevant in your kind of business because you could be a supportive device for a surgical procedure, and if you are not available, the surgical procedure will not happen.

So it is important to understand what the device is doing, where it is involved, and how critical is such a discontinuation or interruption of market availability on the healthcare system.

And we are not talking about devices that are nice to have.

So if you have a device that will give me a better life, but I will not have patients dying if they don't get it, then you will be able to justify that you are not impacted. This is why, going back to your slide, Lawrence, it is very important to evaluate your own organization, evaluate your portfolio, and then decide how you can set a system in a way that you’re meeting the requirement but you’re not over-reporting information and not under-reporting information. 

You need to find the balance.

That's why processes, training, education of the team, and updates of an agreement are key to making sure that you are actually meeting the requirements.

Erik Vollebregt - 47:26
Yeah, updates of agreements from a legal perspective - I can't overemphasize this, because that will avoid that you will get these legal triggers that I just referred to. 

And even, especially on a tender level, I mean, we've discussed a lot about what the responsibility of the manufacturers is. I think also the fact that Article 10a exists also should prompt health institutions to think about, hey, how substitutable is it? How smart is a hospital to basically completely go all in on a single system for a single type of surgery purely based on costs when it could be that when this system is suddenly not available? It takes them six months to retrain the surgeons on another system.

I mean, this can and also should not be, only the manufacturer's problem that health institutions make not so smart decisions on this point.

Of course, this is not accounted for in Article 10a per se, but it does raise the point that competent authorities when they look at this, should actually conclude that the resilience of the system might also need to improve on a health institution level.

Lawrence Yeh - 49:09
Right, that should raise some very interesting questions for all the stakeholders involved.
Absolutely. I'm sure there are a lot of questions from the audience.

Erik Vollebregt - 49:21
I already took the liberty to answer a number. I hope that's okay. I couldn't help myself.

Lawrence Yeh - 49:28
Of course, absolutely. I'm sure that is the value of having this.

Erik Vollebregt - 49:33
People are not happy with the answer, then they can just repeat the question perhaps.

Lawrence Yeh - 49:40
Absolutely. So let's see, what do we have from the audience? Sean, do you have any questions coming in?

Sean Smith - 49:46
So I don't think this one has been answered. Is it to be expected that the notified bodies will assess the implementation of Article 10a in the next audits?

Bassil Akra - 49:57
A very good point because it is part of the obligation of the notified body to check compliance to the MDR. And the MDR includes a specific focus on manufacturer obligations which are stipulated in Article 10. So the notified body's task is not to review what you submitted to the authority. They want to see that you have a system in place.

You have an obligation to have a quality management system that meets the MDR, and they're going to be checking if you actually address the regulatory obligation, and if we look back to the MDR, the MDR expects manufacturers to identify regulatory changes and to actually make sure that they are addressed, and this obligation is not new, and it has a deadline.

So if you get an audit after the 10th of January, be sure when they're going to be auditing your system, they're going to check if you addressed it and how you are doing that, because this is part of the obligation that you need to fulfill.

Erik Vollebregt - 50:56
Yeah, very simple. It's a requirement by 10 January, and if it's a requirement, they can raise a non-conformity against the requirement if it's not implemented, so it's easy as that.
The question is, of course, also to what level of detail they're going to look into it, because I've seen, for example, I think a nice example is the requirement in the MDR in Article 10, for example, to have sufficient coverage in case of product liability, which is a a really interesting requirement.

Because I've never seen a notified body that actually knew what it was doing when it was asking questions about it because you would have auditors with zero legal qualification that were asking questions that were very legal.

So yeah, also here, I think Notified Bodies will start very slowly first by checking, is there a procedure? Then learning about what they see in different types of procedures.

And then, when they have the feeling that they have a benchmark on what is state of the art in these procedures, then they will start to look for deviations from that benchmark. But that will not be the first audit cycle, I think.

Bassil Akra - 52:12
I think it will be multiple steps like you said. 

The most important initial step that you have to do is identification, implementation of processes, and training of resources. So you need to have dedicated people responsible for this task. 

You can't just say I have a process, but it's not integrated into your quality management system. They're going to look to whether are you making use of your process, do you have any cases, or do you have a justification that is not applicable for you.

So it might be for your kind of devices that you are actually a device that is supportive, but it is not essential for the healthcare system, so you might need to build a justification, but make sure that you have documented evidence.

Don't tell them, yes, we are doing this, without documented evidence that are actually integrated in your quality management system.

Sean Smith - 53:01
This next question has been asked by a number of people in a number of different ways, and you've spoken around this to a certain extent, but I'm just going to go ahead and read one of them.

If a manufacturer knows that their device, which meets the definition in Article 10a, is not the only alternative on the market and, in fact it is one of several alternatives, do they still need to notify the authority in case of shortages or supply interruptions?

The question that comes up over and over again is around alternatives, and whether or not you're obliged to know what the alternatives are, and to what extent you are responsible for the fact that there are alternatives or there are not alternatives, and so this is kind of a confusing question.

Bassil Akra - 53:54
Yeah, I think it's not confusing.

I mean, I hope that every manufacturer knows about the alternatives if they are good business leaders. Because if you are actually placing a device on the market, you need to know with whom I'm competing and you need to understand that part of the landscape. So you would not actually just keep it running without looking to the competition.

Now you have two cases, you can be actually having the smallest market share, and you might be able to justify simply that you are not having a big impact because they will digest so quickly.

But you might have a case that there is a lot of additional competition but you have 80% of the market share. So if you will disappear, they will not be able to ramp up their production.

So it's not just about actually having competition but is the competition able to take over the market if you disappear in a period of time? All of these things would need to be considered, but I think Erik can add some additional legal expectations to that.

Erik Vollebregt - 54:55
Yeah, I think what Bassil mentions about you manufacturers needing to know the competitive landscape - it's interesting that there's even a post-market surveillance obligation to do so, right?

Because your post-market surveillance plan actually needs to also address intelligence on other manufacturers' devices that can be relevant for your own device.

So that would basically necessarily be competitors. So if you don't know Post-market surveillance, of course, you get into the really difficult, let's say, almost pinball machine of the Q&A, the Commission's Q&A with all these factors that they give in section 9.2, because this, of course, it's all risk management, right? And risk management is, depending on who you ask, yes, an exact science or no, an inexact science. I mean, there can be all kinds of factors that are relevant to substitutability.

Like, for example, I think the 80% market share factor that Bassil gave is a really interesting one. The fact that systems may be very specific and require a lot of training that I gave may be relevant. But also, The question like, for example, is there required infrastructure, for example?

And I would even say, and this is actually also one that is not addressed in a lot of detail in the Q&A, to what medical state of art should there be substitutability, right?

Let's say, for example, you have a very advanced surgical robotic system for microsurgery. I mean, this usually is surgery that you could also do by hand, except that the results might probably not be as fantastic as they would be with the robotic system, but there is an alternative, right?

So also there you have the question like how, yeah, should substitutability be to the exact same clinical state of art or not?

These are all questions, but in the end, what I've basically seen with the authorities is what they want is that patients do not suffer interruptions from therapy, for example. This is like what they really want to avoid - harm caused as a result of hospitals needing to send people home, hospitals not being able to treat people, or hospitals suddenly not being able to provide the level of care.

So this, in the en,d should be sort of the leading principle when you make this risk assessment, I think. And this is also what your justification should gear towards.

Sean Smith - 58:34
So the last question, because we're just about out of time, and I would like to remind everybody that I've put the link to the survey.

In the grey area, no one says the manufacturer needs to bunker purchase supplies in stock for six months of production and advance. Could the new provision be interpreted as dictating that now they may need to?

Erik Vollebregt - 59:01
Now, it does mention bridging stock as, let's say, also a factor to take into account for the risk management, the risk assessment that you need to make. So for example, if the manufacturer can say, oh, but hey, I actually have, I am going to suffer an interruption of supply, but then again, I also have a year of bridging stock in my stocks. This can go into the risk assessment.

What I find interesting, personally, is that the Commission has opted for the Q&A to not address whether or not the manufacturer knows how much a list of keywords relevant to topics that may occur during the meeting. That there is sufficient stock in the supply chain. That may also be a justification to say, look, there won't be, there won't in the end be any harm because there won't be an interruption of supply at the health institution level because the supply chain is sufficiently loaded.

Sean Smith - 01:00:26
Well, we are just about out of time. There were many, many questions that we didn't get to. We will try to follow up with those in writing. I'd like to thank the speakers again today and I would like to encourage you to reach out to them as well. Thank you everyone for attending this event and looking forward to the next event!