The compliance dates for the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are quickly approaching. In response, Treximo is hosting a webinar series that will cover a wide variety of pertinent subjects applicable to the device / diagnostics industries as they relate to the change in the regulatory framework in Europe.
The third training in our series was held on January 26, 2021 and featured a panel discussion and Q&A session with experts from TÜV SÜD, one of only a few Notified Bodies currently designated under both IVDR and MDR. Download their whitepaper on the topic by clicking here. Treximo’s Senior Vice President of Device and Diagnostics, Ronald Freeze, moderated the session. Panelists from TÜV SÜD were:
- Lisa Blanchard, Technical Manager (facilitator) (EN)ISO & MDSAP Conformity Assessment Procedure Specialist
- Daniel Moreno, Manager, Special Operations and Support
- Dr. Julien Senac, Global Director, IVD Focus Team
- Matthias Fink, M.D., Global Team Leader Ortho, Trauma and Dentistry of the Clinical Centre of Excellence
A full recording of the webinar can be accessed by clicking on the image below.
During the event, the experts discussed:
- The sequence of events from pre-application to certification
- IVDR identified bottlenecks with Notified Body workload and infrastructure
- The importance of intended purpose
- Relevant changes for the clinical evaluation under the MDR
- Higher scrutiny on demonstration of equivalence for initial CE marking
- Post-market surveillance requirements
A full transcript of the webinar is below.
So, welcome everyone. Good afternoon, good morning. Welcome to our third in a series of training sessions on MDR and IVDR at Treximo. I’m Ron Freeze, the senior Vice President of Medical Device Diagnostics and Manufacturing. And today I have the pleasure of hosting a panel discussion with a number of experts from TÜV SÜD, one of the leading notified bodies. And so, I’m going to be very quick, I want to get out of the way and let the experts fill you in on what is going on in MDR and IVDR, but first I wanted to give just a little bit of an overview. First, the structure of this training session, we are having bimonthly sessions focused on MDR and IVDR at Treximo. They are free, we do record the sessions, those recordings are available at our website, if you are interested in seeing either this one again or past ones.
Really, the topics are based on your pressing concerns. We discuss internally, we talk to our stakeholders, we really keep up to date on what people are struggling with and try to frame these training sessions to address some of those issues. We covered medical writing last year in two different sessions. We knew that is a hot topic as manufacturers really struggle with not only the technical aspects of medical writing and the changes there but just the volume of work. And so Bennie Larson, my medical writing lead did a couple of deep dives into medical writing expert expectations. Now we have some of the overview from the notified body themselves. Thank you TÜV SÜD for joining us. And then we’re going to go next with Rob Turner, our Senior Vice President, on the project management side. Really thinking about some of those key points that consider as you’re transitioning, and then one thing he always reminds me of is just making sure we help our clients set up for sustainability, really retaining the gains that they achieve during the MDR or IVDR transitions.
So, that’s sort of the structure of our training session, more specifically today the panel structure. So, we took a lot of questions, we actually received a lot of questions on the registration page, we took those, all of the panelists have looked at those questions. For about the first 40 minutes we’re going to go through an introduction, a little bit more about TÜV SÜD, about the panelist themselves, and then each one of them will talk a little about their space specifically. I’m going to get out of their way and let them do that. During that time we have Belinda Larson, Bennie, and Rob Turner, team Treximo behind the scenes monitoring the Q&A. So, if you have any questions for the panelists please post them in the Q&A and we’ll be monitoring that, and we’ll pose those to the panelists as time permits at the end.
We know we have a huge space thinking about both medical device and diagnostics, and really across the whole gamut of the areas that are impacted. So, we’ll see what we can do for Q&A. We’re mainly wanting to make sure we at least get through the questions that we took on the registration but we’ll open it up at the end, and then I will close at the end. I think that cover the last things pretty well. Once again, the slides and the recording of this session will be available to you on our website, as well as the sessions that I mentioned about medical writing and future sessions as well. We retain those. Those are free for your use to pull those up as you see fit. And finally, we want to maximize value for you, so after each one of these we do send out a survey to hear how it went and also get ideas for upcoming sessions that we will hold.
So, very quickly, and then I will let each of the panelists as they go through their slide, or a few slides, give a little bit more about themselves. But, again, I’m Ron Freeze, I am leading the Treximo Medical Device Diagnostics and Manufacturing team. And I am working here with a prestigious group of TÜV SÜD members. Lisa Blanchard who is the Technical Manager really very involved with the audit program. Also, Dan Moreno who is really the guy behind the scenes that helps manufacturers understand what it will take, map out those timelines, make sure there is a plan in place to navigate that transition. Dr. Julien Senac, very focused on IVD, the technical information for the IVD side of the business. And then Matthias, who is the clinical expert, and he will talk through some of the clinical topics that we received during the sign up page. So, with that, really like I say, I want to minimize my time in front of you. I think you’re here to listen to the TÜV SÜD team, so I will hand it over to Lisa.
So, my name’s Lisa Blanchard. My background prior to coming to TÜV so I have two bachelors degrees and one of those degrees in anatomy and human biology from the University of Liverpool, which is where I’m originally from. My second degree is within psychology from the University of East London. I’ve been with TÜV now since October 2016 so coming up to four years-ish, it’ll be my fifth year this year. Prior to TÜV SÜD I was in the industry for 14 years and I actually expanded through not just medical devices but also pharmaceutical devices as well, and I worked within the regulatory compliance and the quality management system side of both the pharmaceutical industry and the medical device industry.
With regards to medical devices I covered non-active, active, and combination devices. And then within the pharmaceutical realm my focus was on vaccines itself. I am an authorized lead auditor with TÜV SÜD for MDD, MDR, (EN)ISO, ISO and MDSAP, so basically all of our programs that we offer. And most of the global experts, as well as 13485, Plus the MDSAP conformity assessments teams as well. Within regards to the MDR, myself and Daniel who you’ll hear from shortly, we’ve both spearheaded the process for the US with regards to making sure that we can actually get clients like yourselves from start to finish, from the point of pre application review all the way through to the certification piece of the process. We also support our US colleagues when they have questions on maybe specifics on how an application form’s been completed, or how to alter a quotation to make sure that it’s covering all the aspects required to make sure that we can actually give you a consistent quote to support your project, to get you to the point of a decision being made where you get a certificate itself. So, with that I’m going to hand back over to Ron for a little video.
New technologies revolutionize society, but new technologies can also be disruptive. At least until we can manage the risk, this has been TÜV SÜD’s role for over 150 years. To date we have witnessed four major technological revolutions. The first was powered by steam. Following a devastating explosion 22 industrialists united to set up a steam boiler inspection association in Mannheim Germany in 1866. By establishing one of the world’s first inspection associations, our visionary founders gave rise to an enduring legacy and spawned a global industry. Working to increase safety while giving people the confidence to trust in steam power, it was the forerunner to today’s TÜV SÜD. TÜV stands for Technical Inspection Association in German.
Engines and electricity were the breakthroughs driving the second technological revolution. As society and commerce advanced, so too did the inspection association’s expertise. We expanded to electrical engineering, lifts and machinery at the turn of the 20th century with our first vehicle inspections carried out in 1906. The hum of computers heralded the arrival of the third technological revolution. Our ability to send information worldwide as strings of ones and zeros launched the information age, and sewed the seeds of globalization. TÜV SÜD received its first international contracts in the 1960s. With this new global requirement we expanded our range of services to facilitate trade by providing quality assurance of goods across borders, and global market regulatory services.
In recent decades our international expansion has been matched by our forays into new areas of expertise. Energy, management systems, consumer products, food, medical technology, real estate, infrastructure, and more. At the same time the various TÜV organizations in Germany’s Southern States were brought together to form TÜV SÜD, which means TÜV South. Today we stand at the dawn of the fourth technological revolution. Industry 4.0, Smart factories, intelligent software and autonomous vehicles promise ever greater levels of productivity and efficiency. But this potential will only be realized when people have confidence in these new technologies, this is our task for tomorrow. A task we are uniquely positioned to accomplish as we continue to pursue our goal of making the world a safer place by providing future oriented quality, safety and sustainability solutions.
So, while I’m finding that next slide, I’ll kinda just talk around it a little bit, this is the one. So, at a glance, pretty much what that video is trying to show you is that TÜV SÜD is a one-stop-shop. We are a technical solution provider and we have over 150 years experience within the safety, the security, and the sustainability business. We have over 1,000 locations so we’re really globally positioned to support manufacturers from the medical device side across the globe. We have over €2.6 billion in revenue, to date. We also have over 25,000+ employees. And, again, we are here to support legal manufacturers as best we can. Then we have 41% of our revenue actually comes from outside of Europe, Germany specifically, so that again shows the global position that TÜV SÜD has. We really value our people within TÜV and we truly place a lot of pride in the technical expertise that we hire here at TÜV SÜD. TÜV supports safer devices being placed on the market.
And then the next slide, again, we’re just trying to show you the global access that we do have to the market, through all our various locations. So, out of those 1,000 TÜV SÜD locations we are in about 50 countries. And, again, that just allows us to provide solutions across the globe as and when manufacturers need support. Thank you.
Okay, thank you Lisa for the introduction on TÜV SÜD. And, Ron, thank you for having us. We’ll start with a short introduction of myself, my name is Daniel Moreno and I’m the manager of the Special Operations and Support Team. I have a degree in microbiology, immunology, molecular genetics from UCLA, and I have over 10 years of experience in the medical device field working mostly with startups and Class 3 Active Implantable Companies, a couple of non-active medical device companies and feature diagnostic companies. So, I am authorized as a lead technology auditor for (EN)ISO 1345, 9001, MDSAP, MDD, MDR, and IVDR. I’m also a review technical documentation for MDD and MDR, and I’m a local technical certifier for the (EN)ISO 9001, 1345 and MDD projects.
Okay, thank you. So, currently there are 18 notified bodies approved for the MDR, and TÜV SÜD received its designation in May of 2019. And today TÜV SÜD has issued over 152 MDR EC Certificates, and that’s following just nine months of designation. And, as everyone knows, we’ve been in a pandemic for the last year so it shows that we’ve definitely focused and driven to work with legal manufacturers to continue their process towards certification. The scopes range from everything from low risk to high risk devices, including those with animal origin. There’s a huge range of certificates and devices that we’ve certified throughout this 19 month period. And so, I wanted to give you kind of like a high level overview of the sequence of events that will take place from pre application to certification.
Really there’s three main milestones. There’s the pre application phase, there’s the certification phase and then there’s a certification review and decision phase. And so, when we’re talking about the pre application phase it’s talking about making sure that the appendices and the application are being reviewed, and everything is worked out to where we can enter into the certification phase without any hiccups. This phase is very client driven because a lot of the information provided by the legal manufacturer, dates of readiness will help poise the entire project. So, the pre application phase is definitely driven by the legal manufacturer, and where TÜV SÜD will help come in is a tech lead during the certification phase, and we’ll work and help to organize the different reviews that need to take place, different audits, and make sure that everything’s adhering to the timelines that are required through the MDR. And so this phase is where we work together but as a notified body we would provide you with a plan based on our resources to show roadmap to certification.
And in the last phase of certification, review and decision phase, is of course when we have an impartial division looking at the project that we’ve completed as a team. And they may ask for clarifications on certain aspect or they may just look at the submissions that we provided and be happy, and go through the final certification issuance. So, it’s a three main phase project and, like I said, the first one is very heavily dependent on information provided by the legal manufacturer. Let’s see, so for the bottlenecks, there have been a couple of redundant bottlenecks that we’ve noticed through these initial projects we’ve processed. I think most notably is the basic UDI-DI. So, we’ve noticed a lot of legal manufacturers, especially those in the US, are misinterpreting that UDI-DI is the basic UDI-DI, and it’s not coming… So, when we had these on the pre applications it’s very important that they come from one of the designated organizations by the European commission, and there are a couple of them out there already but we really need to see that these are basic UDI-DIs and not confused with UDI-DIs.
The second one is the CND Code. So this is an Italian nomenclature that’s been adopted through the NDR certification process, and this is also something that is missing a lot of times on pre applications as it’s new to a lot of folks. This is something that also needs to be considered when submitting your pre applications. I’ve put in bold here the Finalized Technical Documentation Assessments/Sterilization Assessments. So, these types of assessments are very, very important to the entire scheme of the certification process because there’s certain timelines that need to be developed around the completion dates of these types of projects. And when they’re not met it throws a wrench into the entire planned project. And it definitely moves timelines further off track. So I think, for me, this Finalized Technical Documentation Assessments/Sterilization Assessments, any type of official assessment you’ve done needs to be in a very final shape whenever you’re submitting your pre application, or at least have a solid date on when you expect it to be finalized so we can structure and plan with you the other events that need to take place.
Also, classification rule. The classification of the devices, sometimes we just get the rule and it might be missing the bullet. I know that the reviewers are very strict, they want to see all three categories there. System is also something that’s come up quite frequently, so we really need the legal manufacturer to understand the definition of the system. And if there are CE marked devices within the system, are they going to be assessed, are they not marked and do they need to be assessed independently or as a system? These are all types of conversations we need to have understood at the time of pre application.
And consistency, again, is something across the board that’s just always been a bottleneck because you just want to make sure the information that’s being provided is consistent amongst your intended use, your indications, your descriptions of the device. There’ll be many appendices to fill out in your pre application. It might seem redundant sometimes but this information needs to be consistent as it each serves a special piece within the certification process. Other things are like cyber security, the architecture may be missing.
Okay, so here’s just a recap again of the consistency that was expected. This is a huge issue and it’s truly impactful on the entire project. So, the technical documentation, just make sure that there’s consistency in these highlighted areas, your intended purpose, your indications, contraindications. All of these play a huge role in moving the project forward, and when there is inconsistency it creates a lot of delay on both ends. So, this is just a snapshot of the more frequently touched on items that we have to go back through and get clarity on sometimes.
And then I’ll go ahead and introduce. So, Julien, as I mentioned before, is really the IVD expert with technical information required to move IVDs through from the directives over to the regulation. So, Julien.
Yes. So, my name is Julien Senac. I basically work as a Global Focus Team Director here at TÜV SÜD in the IVD field. The idea is really to move the feel for what, especially the IVDR as a big change in the industry. And as a little bit of a background, I mean, as much as you could hear Lisa from Liverpool you can hear I’m from France, although I did most of my study in the US. I got a PhD from Baylor College of Medicine in molecular and human genetics, and worked for 10 years with IVDs in research lab, and so on. So, right now we are focusing really on the group NDIVD development. I would pass to the next slide just in interest of time.
What’s happening right now with our Regulation Notified Body, as you can see this information was given by the commission in December that there were five notified body designated for the IVDR. Actually today there is only four knowing that one of the five was a UK notified body, so now we have only four that are notified and we are waiting for more to come. And one thing I want to mention, TÜV SÜD is ready to tackle all of that work because as much as Daniel talk about, sorry, we talked about the number of certificate issue in MDR, where actually in IVDR we are the first one to have issued the first ever IVDR certificate but also the first to have issued by one day, but still the first, and certificate done with sampling for class B and C device. Next slide.
Okay. Now, there is a major bottleneck that we see coming and I think you all know, and you all fear that ISO would multiply body workload. We are ready, we are sure that we are ready, however, there is something to remember. There was only 71% of applicant compared to what we have currently designated under IVDD, so about 15 to 16. And out of those there was only four designated yet, and we have a little bit more than a year left. So, now we also have a increase in demand because we’re going from 90% of the market to be self declare and now we’re going to 90% of the market being covered by the regulation mainly in class B and C devices, this is what we see. And then lastly we see also bottleneck right now in multiple type of infrastructure, which is the European Reference Laboratory who are necessary in order to evaluate class D devices, so so far no notified body can do anything with class D devices until we get the European Reference Lab designated. The EMA interaction for companion diagnostic is crucial. We are in execution with EMA but nothing is concrete so yet we’re also missing that.
And, finally, the common specification also for class D device that we are expecting to come. So, all of these are the one that will in the next year need to arrive very fast in order to move all of this project forward. I won’t talk much about the common mistake, that’s what Dan said, we are pretty much in the same thing in the IVDR consistency. And I would emphasize on intended purpose, be sure your intended purpose is right because this is a key for classification and it’s a key for the route you want to follow for assessment, but also anything that is in to be reviewed in your [inaudible 00:24:51] is basically intended purpose, so be sure you have that knocked down.
Okay, with that I will introduce the last member of the panel, Dr. Matthias Fink. And I’ll let him do a more in-depth discussion, but he again will take us through the clinical aspects and different things to be considering on the clinical side of the transition. So, Dr. Fink.
Ron, thank you very much for the introduction. Yeah, just a good background on myself, I’m a board certified orthopedic and orthopedic trauma surgeon. I have nearly seven years of clinical experience; last position was at a maximum trauma facility in Munich in Germany. And I joined TÜV SÜD nearly five years ago, it was April 2016 in our headquarter in Munich as a clinical reviewer at that point, in our Clinical Center of Excellence. So, just to give you a quick idea of what we’re having within TÜV SÜD since over 10 years now is a team of in-house physicians, clinical reviewers who are responsible for the clinical reviews and, of course, with the requirements now under the MDR much more focusing on clinical. We are building up and we are really significantly increased our team. And so just to give you a quick idea when I joined TÜV SÜD five years ago in 2016 I was the fifth clinical reviewer, the fifth physician working for TÜV SÜD in-house. I was the second orthopedic surgeon joining the team, and now as of January 2021 I don’t even 100% sure what the actually number, but I think right now we’re having at four different clinical teams with combined I think 22 or 33 physicians in-house, working full-time for TÜV SÜD.
As I said, there’s four teams. I have currently two roles. I’m the Global Team Leader for the team of orthopedic and dental reviewers, only from the physician side. And since I moved here to the US and joined TÜV SÜD America, since last year I’m also responsible for the team of clinical reviewers here in the US. So, next slide, please? Just a very quick high level overview, I could fill the next two hours just talking about the clinical requirements under the MDR. I mean, I know you’re all aware of that, that if you compare the MDD or the ruling of the MDD with the MDR, there are so much more involvement now of clinical, hence the reason we updated our team over the last three, or four years significantly.
There are certain changes from the MDD, from the MDR. I mean, in general, if you have a device on the market and you have sufficient clinical data under the MDD, and it’s data, all the clinical data on the device either coming from clinical investigation pre, post-market, or any kind of registry data published literature. This data is also of course in most cases valid and good under the MDR. So, that’s good news for everyone. It gets a little bit more difficult, of course, for, let’s say, legacy devices with limited clinical data and a long market history. And also, as we all know, there are a couple of new documents requirements under the MDR we didn’t see before, so now there’s a clear definition that manufacturers need to have a clinical evaluation plan in place, and this clinical evaluation plan is applicable for all devices so it’s not limited to, let’s say, new MDR devices it’s also applicable to legacy devices which were already MDD certified.
With that comes the requirement having clinical development plan, and also there’s a new definition which also has to be as part of an evaluation plan and needs to be defined by the manufacturer, is the definition of clinical benefits to the patients. So, I mean, this was one of the main purpose of the MDR when this legislation was drafted to be a little bit more patient focused, refocusing on safety and performance aspects for the patients. So, this clinical benefits now need to be clearly defined by the manufacturer and they need to provide the outcome parameters to demonstrate those proposed benefits to the patients. And, of course, there’s a much bigger emphasis now on post-market surveillance. We all know that there will be a much higher scrutiny because, this last bullet point here is cut off a little bit. I’m sorry about that. That now with the MDR, especially for implantable and class 3 devices, there will be either every year or every second year an update of the post-market data with the periodic safety update reports, which have to be for those devices reviewed by the notified body.
So, it’s not like in the past that after every five years the notified body will do an in-depth review of the clinical data. In the future there will be a much higher scrutiny with this manual annual updates of the post-market data. And with the MDCG 2020, we also now have a, and I think this is very helpful, a template how this post-market surveillance plan should look like and how all those aspects of the PMCF plan as defined in NX14 part B can be covered. One very, let’s say, I think significant change of the MDR is the much higher scrutiny on demonstration of equivalence, especially for the initial CE marking. Under the MDD a lot of medical devices seek initial CE approval based on demonstrating equivalence to a competitor or device from the same portfolio of the same manufacturer.
We had a lot of problems in the past, devices that were approved with equivalence and then did not perform on the same level of safety, and a lot of recalls happened. I don’t mention any one specific here, I think you’re all aware of, let’s say for example, the metal on metal hip prosthesis in my orthopedic field, bad example for that. A lot of devices got recalled because they were based on equivalence demonstration which were a comparative demonstration equivalence, but then in the post-market setting did not lead up to the clinical performance. So, and right now with the MDR manufacturers, they still can claim equivalence. The equivalence pathway is still open but the scrutiny is much higher so manufacturers now need to have in-depth access to the technical documentation of the claimed equivalent device, and for implantable or class 3 devices the MDR is quite clear. This means they need to have proof in form of a contract to have continuous access to the technical documentation of their… If they claim equivalence to competitive device to their competitor’s documents.
So, this basically limits, I think, the equivalence approach to very few exceptions, probably when manufacturers are going to claim equivalence to one of their own devices, but it definitely will lead to a much higher number of required pre-market legal investigations. And also big question, of course, when we talk about legacy devices, devices already marketed under the MDD or the AIMDD. A lot of manufacturers are struggling, they might even have a long history on the market. Let’s say, 15, 20, I mean, I’ve seen devices with 40 years market history. Not much has changed, of course, but probably as the regulations were not as strict in the past, especially if you talk about long market history devices; devices which already place in the market before the MDD even came in place in 1993, or because it’s a device it’s now going to get up-classified with the MDR, or will come under the higher scrutiny, let’s say, class 2B implantable device which probably was not sampled because it is a legacy device.
And in audit, let’s say, in the last 10, 15 years and manufacturer might not have fully kept up with collected clinical data, so and of course no one wants to see devices with very good track record and which are widely used in Europe to now be obsoleted from the market just because manufacturer probably did not fully keep up with the requirement and collected data. So, to have in this transition period with legacy devices, in April last year the MDCG coronation group published a 2020-6 guidelines on sufficient clinical data for legacy devices, and they also provide a definition of well established technology. Since this is a term sometimes used in the MDR it’s not defined in the MDR, this guidance document now clearly defines what is considered a well established technology and they also provides some form of an appendix at the end, categories of clinical data which could be used depending if the device can be considered well established technology or not.
But none of the less, even the manufacturer are able to get the MDR certificate for legacy device, which is, let’s say, based on this approach considered with well established technology with a limited or lack of clinical data. They are still required, of course, to collect clinical data on their own device in the PMCF, so this MDCG 2020-6 only helps manufacturers for the initial MDR certificate, but then of course they still need to acquire in the post-market the clinical data on their own. And thanks for your attention, and I think it’s back to you, Ron.
Perfect, had to check and make sure I was unmuted. So, and, Matthias, thank you so much. I will just tell people that as we were looking at the question that came in I can listen to Matthias’s summary there of well established technology and know he was addressing a very specific question about technology that has been out for 20 years, or something like that. And what do we do as a manufacturer, and it actually made me remember to write down a word and make sure that I said it, and that is, it is definitely the panelists are out there that, as many others are talking about what their understanding of the requirements are today and how they would approach them at a high level. But as with all people that protect the public health, at the end of the day they need to look at the details of the information that is submitted and do that review.
And so, one place that we wanted to make sure we’re very careful of is that there’s not any view of consulting, or any perceived view of consulting, and so that’s why, again Matthias, very nicely done. I’m just looking at what the guidelines are and looking at the questions that were submitted, and going through some of that. I heard some of the same things when I heard Dan, and Lisa, and Julien talk that some of that was based on the questions that we received. And then you may have seen me looking down a number of times because we’re looking at questions that are coming in, trying to make sure they’re the right types of questions. Not too specific. I will say, we’ll have the contact information at the end of these slides, you can reach out to TÜV SÜD or to me directly, or Our Treximo team, and we will absolutely get back and help you with any very specific questions. But I’ll go to some of the questions that we did look at as we lead up to this panel discussion. Maybe I’ll throw one right to you, Julien, I won’t go all the way back to a couple.
I have some on Eudamed, some on Brexit, some UDI, things like that but maybe, Julien. First off, so a question came in very early, so everybody saw, of course, the medical device regulation timeline shifted out a year. Do you see the same thing happening with IVDR, the timeline shifting out, what are your thoughts, what do you see? Again, I know you probably get this question often, I know you can’t of course answer more than just what is being discussed in different notified body working groups, and things like that. But, I guess, what is the current discussion around the timelines for IVDR, Julien?
Yeah, thank you for the question. And basically we all see the emergency in the urgency of the situation here. Just to remind you the number of notified body designated for IVDR, and having more than a year to complete most of it so people stay on market. I will have to say, unfortunately that’s not exactly what we heard from the commission. I mean, I can base on the word I heard for the commission last year at the top prime meeting, and the answer was, “No, no, no. There is no way that we’re moving the date of implementation of IVDR.” And one reason for that is because we really need IVDR, we can see with COVID-19 that some tests are on the market because they’re self declared, but they’re not up to par. So, one more reason for the regulation. So, that was the last official word from the commission, that there was no moving of the date of application.
Another sign that it might not be a move is because the opportunity to move the MDR would have been the perfect opportunity to also move the IVDR to just say, “Hey, we’re moving everything by one year.” And they didn’t do it, so somehow there is a reason behind that. To me it’s tough to explain but there is a reason behind it. What I can foresee, if there is any form of extension of deadline, it would happen in the last minute of the last hour, and it will be maybe on very specific. What we’ve seen in the past, for example, for the class 1 reusable devices, there were an extension just for them at the beginning. There were like some lenient implementation. So, I will say that you may see some of those elements on case by case basis, or on type of product basis, but I will not try to say or try to expect a full delay as of today, or if it does happen it will be last minute. Which means for manufacturer, please do not expect that delay, keep on working on it, keep pushing on it. If your problem is a fact that there is not enough notified body then you put pressure on the commission. That’s the best approach, but be ready because if you’re not ready then you will always be returned back to, “Why were you not ready? You had five years to get ready.”
And so, your file is not even ready. And I think that’s the big message. It doesn’t matter what happen, please work on it, please move on with the transition on your side because that’s still a very long process.
Very good. Now, thank you so much. And it’s very consistent with what we’re saying as well, that you have to plan all of the reasons why it’s such a hard transition is also why it is so important. As you say, because I think you use the words in one of our discussions, the flip of 90% now are self certified and it’s almost flipping upside down where 90% will be going through a notified body as we go forward. And, again, that’s part of the reason for the change, is the upclassification of the increased scrutiny. Maybe I’ll go over to you, Lisa, in your auditing role that you have. So, with COVID there’s been recent guidance around remote auditing that’s continued to come out, but how do you help manufacturers stay on track? How do you complete the audits? Overall, as a notified body and, again, Julien focused on the technical information, you sort of focused on the quality system on the auditing side. How is the pandemic impacting what you do and how are you maintaining the pace to get manufacturers transitioned?
Okay, so we are still traveling, not all auditors are traveling. Obviously we’re taking precautions to make sure the people who can’t travel, for whatever reasons like ailments, they’re not traveling, they’re focusing more on the remote audits for pre existing clients. We have a group of people who are willing to travel, and we’re utilizing those people for the actually stage two audits for the initial certifications right now. So, we’re essentially planning the technical file assessments upfront, making sure that they get completed as far out as possible to ensure that there is a positive closure of those technical documentations or sterilization assessments. With the intent to have a tentative stage two date lined up, as long as we go through one to two rounds, no more, on the technical file assessment side with the deficiencies.
If everything runs smoothly into plan, then the stage two would happen as tentatively planned. Then again, we do have people who are willing to travel so they’re the ones that are really spearheading everything, cope and support, and making sure these audits happen right now. So, we’re very appreciative to the team of people that are on the road traveling for these audits right now.
Very good. Maybe I’ll pull you in, Dan, a little bit from transitioning the manufacturers. You said a little bit about the overall plans and just the transition plans that you help manufacturers put in place. We have a number of different questions just generally about, “How do I know if I’m on track?” And, again, maybe that’s not what Julien making the point of, you can’t be betting on a one year delay of somebody sitting here in IVDR manufacturer that really hasn’t gotten too far down the path of moving from… Sorry IVD manufacturer too far down the path of transitioning from IVDD to IVDR, or even getting a plan in place. What should they be doing? What are the next steps for them? Are they in trouble, or how would you approach a conversation with people on the phone that might be trying to figure out are they on track, or what should they be doing now?
Okay, thanks. So, I think that probably the most important piece for a client to consider up front is, have they done a review of the MDR, is their product a medical device? And, if so, how are they going to certify that device, because a lot of times we get questions at the very preliminary stages where classification could be a concern, or a question. And, really, at the point of application that should be something that’s already kind of sewn shut. We will, and we’re required to assess the classification given by that legal manufacturer, but any clarity there would require more rounds of review and back and forths with the client, so that’s definitely a time consuming activity. To be the most prepared you can for a legal manufacturer, I think the key is to… If you’re going through an initial certification, to start the conversations early, show intent early. But it’s important also to make sure that you have everything needed on the pre application, every field on there needs to be populated because even the most minor piece of information being left out could result in further clarification request, or further activities on the back end of the project.
So, one thing that’s kind of unique with the MDR and IVDR is that in order to present the legal manufacturer with a nonbinding quote as accurate as possible, we require a lot of information upfront. We do a lot of internal discussions and planning of the project, so that way when we present these nonbinding quotes to the legal manufacturers, we’re able to give a well rounded picture of what it’s going to take to get the certification. Barring everything is met on their end also, as far as dates of completed technical documentation. Like Lisa said, the minimal number of reviews back and forth between the TD reviewers and the legal manufacturers. So, just based on experience we try to space out these projects so that we’re not having to push dates, and it’s a lot of work upfront and this is a huge difference between MDD where now it’s like the client is almost getting a full picture of the certification process with their nonbinding quote. We try our best to do that, and so preparing upfront is just so essential in the certification scheme now.
Very good. And I have at least one question here, I just sort of open it up I guess. What should manufacturers be doing about Brexit? How is TÜV SÜD engaging in that activity at the moment? I don’t know, maybe Lisa or Dan, I’ll look to. You’re on the top of my row here, just thoughts of the day now that Brexit is done, what are the actions that manufacturers should be taking?
Favorite subject. So, TÜV SÜD is actually applying to be a notified body within the UK. So within the United Kingdom they’re actually going to have a separate conformity assessment procedure. So, just an additional regulation to add to everything else we’re already assessing, that’s going to be called a UK CA Mark. So, it means an additional conformity assessment scheme and an additional mark possibly to be placed on the medical devices, those transition periods for the classifications of devices right now within the UK. So, for example, class 2B non-implantable devices, class 2A devices, Julien can correct me if I’m wrong here, but IVD list B and self test IVDs, their transition period’s eight months from the date January first. So, they have until August 31st to move through this process to ensure that they have a UK CA Mark as well. So, there’s a lot of stuff going on with that and we’re kind of working through the new requirements ourselves, but definitely as we move through these conversations and these panels, we can bring up additional things as we move towards being a designated notified body for this specific conformity assessment scheme.
You’re correct, and if I may just add one point. The registration is something that you really have to do if you’re going to UK, knowing that your CE will still be okay to be entering the market until, if I’m correct, June 23rd 2023 or something like that. So, but the registration is a new requirement that you would have to perform, so be careful on that.
Very good. No, thank you so much. And I know it’s new information now is getting solidified, it is, again, how to navigate through that as well. Matthias, I have a few things for you, I’ll try to narrow them down. You did a good job of answering… Again, I say, compliments on trying to answer the well established technologies in that space. I’m getting a lot more around, I guess, state of the art but then also just maybe from your perspective walking through what people should expect with the panel review for active implantables, and things like that. How’s it different and how’s it the same as it used to be, how should manufacturers be preparing for the changes for more of the high risk devices?
It’s a good question. I mean, with panel you mean the expert panels?
Yeah, okay. Just to be clarified on that. I mean, they were just published. If you look on the website of the European Commission, just beginning of this year they finally published the expert panels. I think we have 11 now, they have published the names. They are not active yet, so it was a very lengthy process, but then they were training them. It’s not clear yet when those expert panels will be ready to accept submissions. And, of course, as you’re all aware, calling to article 54, certain implantable class 3 and class 2B devices according to rule 12 have to go through this expert panel, but only if they are, let’s say, novel devices or devices which are including. Let’s say, a new indication or include any kind of new safety features on new risks. So, most, sorry, legacy devices, even if the initial or the first MDR application has to be considered the initial application, most legacy devices will not have to go through that expert panel.
This is really something, this is applicable for mostly new devices, there’s an MDCG guidance document, and I think 2019 point three, I’m not 100% sure, will clarify what requires an expert panel, but of course… And then there’s a very strict timeline, so within 21 days the expert panel needs to decide if they have to consult, or not, on this device. And within 60 days then they have to write an opinion, if not [inaudible 00:51:36] can go ahead. So, regarding the overall application process and the review process of a notified body that might differ a little bit within different notified bodies. There will be a maximum of two month that might have to be added on to the certification process, because [inaudible 00:51:55] allowed to move on before the opinion from the expert panel is present.
What’s going to happening if the expert panel disagrees with the notified body? We don’t know yet. I mean, we have internal procedure in place, there will be a communication then, of course, a notified body and the manufacturer have to write an answer. As on that, so far we don’t know when those expert panels will be available, so we are still waiting for that communication from Brussels.
Very good. No, thank you so much for that, Matthias. I have two more questions, they might be real quick clarifications. I just want these have come in online, I want to make sure I provide them. And, again, if the answer is “it depends”, that you need the detail, and you can’t consult, do feel free to use that. I’ve worked in regulatory many years so it was a common statement I used, but maybe, Dan, this one would be for you. From the online it’s, “Does each notified body provide their own pre application?” Is what it says, I just want to make sure I don’t misunderstand, that was the entirety of the question.
Okay. Yes, I know we have our preapplications, and the space of information needed to initiate the certification process and issuance of the non binding quote. It’s TÜV SÜD’s specific letter head documentation that’s been created by us, and so that’s specific to application with us for initial certification.
Okay, and I thought it was probably a pretty simple one, and maybe then one more for Matthias. I have one for you Julien, if we have a couple of minutes, but not to rush you Matthias. This might just be what you were trying to answer, just to give the person that asked it online. Regarding meeting the state of the art, what is the approach that TÜV SÜD is talking about what version of the standards they should use when there is no harmonized standard under the MBR published?
I mean, from a clinical side, I think this probably might be addressing more our other colleagues like Lisa and Dan. I mean, from the clinical perspective the most relevant standard, of course, is the ISO 14155 on clinical investigations on medical devices, which were just updated last year so we just got the final version. I don’t know if the 2020 version was published I think in September, October last year. But a lot of the ISO 14155 is now included in the NX15 in the MBR and, of course, to fully align with the MBR that was one of the main reasons for the update of the ISO 14155. So, I can only speak for the clinical team, if a manufacturer is still conducting a clinical study or something according to the old ISO version, this case the 2012 for 14155, we will at least expect some form of a gap analysis for the relevant topics, how they’re going to be addressed in the future. You said it, at this point there is no harmonized standard. There’s a complication from the European Commission that standards which were harmonized under the MDD cannot be considered harmonized on the MBR… So, we still have to wait until we probably get the harmonized standards published.
Very good. Anything to add to that, Lisa or Dan?
No, I agree with everything Matthias said. And my mind, again, goes straight to the same thing, anything that you do outside of a harmonized standard, even if it’s not listed from the European Commission within the list, there should be a gap analysis and a justification for why a specific standard’s been used outside of that, just to ensure that you’re fully following the state of the art. So, I agree with what Matthias said.
Very good, and I do have three minute until… Again, I could go on, I have things on Eudamed and started to go through that, how do you… Julien, I’m not going to let you answer the question but it is, how does TÜV SÜD help knowing the global impact that change in certificates has on manufacturers, or things along those lines. I will just say to all of the people that attended that, and this is just the tip of the iceberg, we knew it would be. We just wanted to make this panel discussion open, have a chance to get to know some of the experts at TÜV SÜD a little bit more, take any questions that came in and just want to give the biggest thank you to the TÜV SÜD organization for taking the time to join us. We have a lot of clients that are asking us a lot of the same questions, and we know we can help them and we know that there’s great notified bodies out there working hard, like TÜV SÜD, that is I think Matthias has done a great job of saying how much staffing up there is of those expert organizations.
And Lisa has done a good job of just saying how robust TÜV SÜD is in helping manufacturers manage. I think it was a great insight into what TÜV SÜD specifically is doing to help manufacturers. So, I thank you for your time. I did want to do the last slide, let me try to share my screen one more time. I think it’s this one. And so, just to close the session, apologies for flipping through really fast, I did it again. And so, here is the contact information, you can reach out directly to TÜV SÜD if you have MDR specific questions or IVDR specific questions, these are included in the slide deck. And then, as always, one final thank you to the panelists. Greatly appreciate your time in preparing and being here today, and here’s my personal or my email at Treximo, as well as the Treximo quality training email. If you have any questions, reach out to us. You will be getting a survey where you will have another chance to ask us questions, and look forward to Rob Turner, our Senior Vice President on the project management side, walking us through the top considerations for EU MDR, IVDR, project leads before and after implementation, which we’re planning for March 23rd. So, with that I will close. And I’ll say one more time, thank you to the TÜV SÜD organization.
Thank you, Ron.