Easy Medical Device Podcast

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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.

To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.

We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the FDA.

After listening to this episode, you will have a minimum understanding to place your product to the US market. But anyway if you need support you can contact Michelle or me to answer your questions.

Who is Michelle Lott

Michelle Lott is founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!).

She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.

Links

• Michelle Lott Linkedin: https://www.linkedin.com/in/michellelottraqa/
• LeanRAQA website: https://LeanRAQA.com
• Episode Unannounced Audit: https://podcast.easymedicaldevice.com/17
• Article “510k Substantial Equivalence”: https://easymedicaldevice.com/substantial-equivalence-on-a-fda-510k-process-how-to-demonstrate-it/

The post Register your Medical Device in the US with Michelle Lott (FDA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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There are many ways to register a Medical Device in the USA and I propose you to listen to Michelle Lott that will tell you the basics of the FDA regulations. The post Register your Medical Device in the US with Michelle Lott (FDA) appeared first on Medical Device made Easy Podcast.

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I know that on the title the focus should be on the In-Vitro Diagnostic situation but I promise that you will not regret this episode if you are on the pure Medical Device industry.

Maurizio Suppo, from QARAD (Guess about the acronym? Maurizio will reveal it at the end) is really a great guest and I really enjoyed to discuss with him about the situation regarding the IVD industry but also a lot of other topics related to Medical Device in general.

Here is a highlight of the topics we will discuss:

• The urgency for the In-Vitro Diagnostic Industry to wake up and start engaging with the new IVDR
• The risk if some manufacturers are out of business
• Notified Body Situation for the In-Vitro Diagnostic Regulation (IVDR)
• The proposals that could be made to the European Commission in case some manufacturers are late
• The talk that Maurizio will do at the TOPRA Symposium 2019

I know a lot of people are asking me if this is possible for the European Commission that they extend the due date. Maurizio provided his answer and I would agree that this is a great solution.

Who is Maurizio Suppo?

Maurizio Suppo obtained his Ph.D. in Molecular Biology from the University of Turin. He held executive positions at several world-renowned IVD companies and was the Director of the European Diagnostic Manufacturers Association (EDMA). Maurizio joined Qarad in 2012 and became co-owner in 2016.

Links

• Maurizio Suppo Linkedin: https://www.linkedin.com/in/maurizio-suppo-24204917/
• QARAD website: https://qarad.com
• Subscribe to QARAD newsletter: https://www.qarad.com/news
• TOPRA Symposium 2019: https://www.topra.org/sym2019
• Episode 26 with TÜV SÜD on IVDR with Andreas Stange: https://podcast.easymedicaldevice.com/26/

Podcast Transcript

• Welcome to the Medical Device Made Easy podcast. Here is Monir El Azzouzi from easymedicaldevice.com. And today we will talk again or once more, one more time about IVD, so, in-vitro diagnostic manufacturers. This is a topic that is less discussed currently because we are really focused on the MDR. But I wanted to find some that can help us to understand the situation for IVD manufacturers currently. And for that I have with me Maurizio Suppo from QARAD who will be our guest today, and he will really guide us through the situation for IVD manufacturers and will help us also to know what they should do already now to be in a good shape for the future. So, Maurizio, welcome to the Medical Device Made Easy podcast.
• Thank you, Monir. I hope I will be able to give some useful information for the audience.

Introduction of Maurizio Suppo

• Yeah, I’m sure you will be doing that. So just for the beginning, Maurizio, can you just introduce yourself for the audience?
• Yes, Italian. I work in the IVD industry for more than 33 years always in the quality regulatory environment. So that gave me a good chance to follow up from a situation that in the beginning, Europe was fragmented. There were countries without regulation for IVDs, countries with some regulations only for certain selected types of IVDs and countries with more general, you know, I remember France, Germany, then later on Spain, regulations. And then I lived through the, writing and the implementation of the IVD directive. Okay, that’s more than 20 years ago, of course. And now there is the second big step forward of the European Union in terms of legislation with the IVD regulation.

New Rules for In-Vitro Diagnostic

• So it’s good then you have kind of all the history that happened for this kind of regulation, which will be great, and I think it will be great then for the audience to really learn about that and understand it. So, just for starting, so maybe we can still continue with the history for IVD (In-Vitro Diagnostic) and IVDR (In-Vitro Diagnostic Regulation). So, what is exactly the kind of changes that were happening there? What is the starting point now and what is our current situation regarding the products that will be now considered within IVDR?
• Well, essentially the biggest innovation is that the European authorities have really decided to close the gap that we have in Europe versus the major legislations. And, of course, everybody has in mind FDA right. Because the situation was really, the delta was too significant. Think about high sophisticated products, which are in an area that is particularly sensitive to people, which are the tumor markers, in the United States’ FDA. Not only there, also in other legislations, they are quite highly regulated, all the cancer markers. And in Europe, they were under the directed framework. They were self-certified.
• [Monir and Maurizio] Okay.
• Companion diagnostics, the same. In Europe, self-certified IVDs and in the other legislations, very highly regulated. So the European authority really decided to close the gap by shifting the European legislative framework in a direction that is much closer to FDA in terms of complexity, okay, and I would say even cost, but not really exactly duplicating the modalities for the registration. So Europe, in that, retains its own unique approach. But overall, I have to tell that clearly the cost of compliance is going up. Okay, the cost of compliance for IVD companies, it’s clearly now being driven up, and that, Monir, as we were discussing before, it’s likely to have an impact on how the shape of the IVD market will look tomorrow. That brings me to highlight the major difference between the regulation and the directive is this revolution in the way that the products are classified. At most importantly is the revolution, the complete flip around of the ratio of products subject to the notified body control and the products that were self-certified.
• Yeah, I can remember that. Yeah, before, so the classification was not really the same as for medical devices, and, as you mentioned, they closed the gap maybe with the FDA, but I think they also closed the gap between the medical device products and the IVD product because in terms of classification, the way you are considering them, we see similarities also now on the chapter, MDR and IVDR.
• Totally correct. Totally correct. And the point, the point is that we have under the IVD directive, we had basically only 15% of IVDs under the scope of notified bodies, okay. And, you know, these are all the products that were in Annex II of the IVD directive, blood typing, hepatitis, toxoplasmosis, et cetera. And 85% were in the self-certification regime, and these are not my data. These are data from the European Trade Association, MedTech Europe, of course. And now these percentages completely flip. With some people, they are even saying that maybe only 10%, not 15%, of IVDs will be left in the self-certification regime. So you name a reagent, just name it, and every likely it will fall under the, the control of notified body. And that, let me add, it’s complete mind paradigm shift for many IVD manufacturers, which let’s face it, until now, they have happily lived in what I call the blue ocean of self-certification with no clue at all of what does it mean to work with a notified body.
• Yeah, they never had any audit. They never had any unannounced audit, surprised audit, or any nonconforming managed .
• Not only, not only that, which is an extremely valuable point, but they never had their technical documentation reviewed and challenged by an outside organization.
• So it will be really a challenge also for them. I mean, a challenge for notified bodies, because there will be really a big need now of notified bodies for this area but also a chance for all the manufacturers where they can be surprised where before they were able to sell the product without any issue, and now they will be challenged by a notified body saying that maybe their product is not correct or not compliant. So it can, what happens,
• And that, Monir, brings us to the other salient and significant point of the regulation, is the concern that industry has on the notified bodies. Because, okay, it’s clear, the European regulators sent a strong signal saying we want basically all of the IVD market under the control of notified body with very few exceptions, which are the products that remain in class A. And then it’s understandable, but on the other side, we are concerned, when I’m saying we is consultants, of course, industry, of the fact that the notified bodies, the European authorities, they have raised the bar so high for notified bodies in terms of competence, in terms of independence, needles to mention the joint assessment audits that notified bodies are subject. Also medical device notified bodies. Which are much tougher, okay, than the one, the processes in the past because, Monir, you know that in the past, notified bodies were nominated and monitored only by the authorities, the health authorities of the country that they belong, okay.
• Yep.
• And now with these joint assessment committees. So, the bar has been raised so high, and this has intimidated many notified bodies from applying to become a notified body for the Rs, for the regulations. So we have seen a significant reduction in notified bodies for medical device regulation that have applied, okay. Now we are at number four, nominated.
• Yeah.
• But you remember the story. You know, from 80 to 58 when this joint assessment audits came into place, and now from 58, I don’t know how many notified body have applied for the medical device regulation, probably 20, you know. It’s very secret. The European Commission doesn’t disclose data. But if we look at specifically at IVDs, you know, seven or eight have applied. And now we discovered that some have dropped out from the race. We all know about LRQA. We all know about UL. You understand. So, NSF was also a notified body that applied, particularly with the mission of being the partner for the IVD industry. And then it was forced to pull out of the race.
• Yeah, so, as you mentioned, there is a big need of notified bodies. We have four notified bodies for MDR as of today. So, BSI UK, TUV SUD, Dekra, and recently yesterday, IMQ, at the day we record. But I checked again the list and the NANDO database, and zero are still for IVDR.
• Which is understandable because the commission clearly wants to progress what is more urgent now. The most urgency is on medical devices because their deadline, their date of application, the end of the transition period is like 10 months away.
• [Monir] Yeah, true.
• But for IVDs, so it’s understandable that IVDs will come later. But what is more concerning is that with a third, you know, if we are lucky, we may have seven, maybe even, say, eight. You know, some people, they say six. It is roughly a third of the notified bodies for IVDs that we have today under the directive with a workload that has been estimated, again, not by myself, but by MedTech Europe, to be at least eight times as much as they have today.
• Eight times for manufacturers or for the notified bodies?
• No, for the notified body.
• Okay, so they take eight time more resources–
• With 1/3 of the notified bodies.
• Okay.
• So you do the math, and what is the result? The result is potentially long, long waiting lists. You know, these massive, massive amount of workload that will hit the notified bodies very hard when the time will come. And this is another excellent point that we, Monir, we already discussed before when were prepping this cast. Is that one thing is are the official deadlines that you see in the regulations, okay, everybody knows that it’s May 27, 2022, okay, for IVDs. But in reality, the real deadline that IVD manufacturers will be confronted is the date that the notified body will give them for submission. Because the notified body, if we look what is happening already today for the medical device colleagues, the notified bodies, they are saying, hey, if you want me to approve your medical device by the May 27, 2020, you know, next year deadline, you have to submit the documentation, the whole set of technical documentation to me by October this year. You know, we are almost in September, okay. September is few days ahead of us, and medical device companies may face an October deadline, which is like a month away for the submission of that. This is shocking, okay. These deadlines, these soft notified-body imposed deadlines, are the harsh reality with which industry will have to confront.
• Yeah because I think everybody now is thinking May 2020, but at the end, it’s really not the right date. And I can also understand notified bodies, that they need some time also to review all the documents and then to be giving the approval. But yeah, it’s really, I mean, it’s a lot of time that is provided for them with less time for manufacturers to be ready also for the notified, for the medical device regulation. I think it will be the same that will happen for the IVDR. So we consider May 2022, but it will maybe October 2021 that everybody should–
• Exactly, exactly.
• Okay, so I see also as we discussed about MedTech Europe, I see how they were already alerting about all those kind of issues. And we start also to see a lot of countries like USA or Australia that starts also to provide some warning to the European Commission. What can they do? I mean, what is the consequence of that? Because everybody now is saying maybe we can extend the due date, et cetera, so what’s your idea on that?
• But first of all, you’re totally right in the concern that it’s on the industry side. Everybody knows that MedTech Europe, Serge Bernasconi wrote a letter to the European Commission saying, hey, you know, this is, we have a certain sense of urgency, and the time is running out. What are the mechanisms that you are putting in place, you, the commission? And the European Commission replied very formally saying, yeah, for the moment, everything is fine. We are running along the, it’s normal cruising. But people are concerned. So what will happen? Nobody has the crystal ball, okay. I am kind of skeptical when I’m hearing people saying, yeah, you know, at the last minute, the European Commission will just push further back in the future the deadlines, which is, in other words, they will extend the transition period. I don’t think it will happen because it will imply an official modification of the regulation, okay, which is something that I don’t think the European Commission will consider. What more realistically, but this is purely my position, will happen, it is something like it happened already with the MDSAP. Our people that are on the line may understand, they know that MDSAP is the Medical Device Single Audit Program. And the Canadian authorities, they were crystal clear, you know, January 1st, 2019 is the deadline you need to be certified by MDSAP if you want to continue to sell in Canada. So what happened, so we are talking about facts, Monir, it is not speculation, okay. As you and I know, these are facts. What happened is that the Canadian authorities, they realized that there was also in this case for MDSAP certification, there was a bottleneck. So many companies have applied. They may even have received the audit but not the certification itself purely due to workload from these, of course, they are not called notified bodies. In the field of MDSAP, they are called auditing organizations. And so the Canadian authorities, they basically said okay, if you can show with documents that you have applied, maybe you even had the audit, and you are just waiting for the certificate to be issued, it’s okay. You are okay, don’t worry. Later on, they even went further. They said, okay, if you have applied, and you have not received the audit yet, okay, it is not your fault. We understand that the auditing organization are very busy. And there was a third step, which is really demonstrated how flexible the Canadian authority were. They said, okay, if you have already the CAMDCAS, which was the former Canadian regulatory regime certification, it is still okay, but provided that you will apply, and you will get the MDSAP certification. Okay, so these are facts. So what I think may happen is something similar. So, the European authorities may say, okay, listen, if you can show that you have contracted, not contacted unofficially because everybody can unofficially get in touch, but contracted the notified body, and you have made the application, raised your hand and said, we are ready. We have all the technical documentation, and our quality management system is okay. And the notified body had no time to come due to workload, I think that it’s very likely that the European authorities will say, you know what, your current CE mark, because, of course, they are directive-related CE mark, it’s okay. And it grants you continued access to the European market until the notified body will come.
• No, it’s clear, and I think the European Commission should try to find those kind, I mean, to maybe disclose or mention about those kind of scenarios because it’s really important for manufacturers to be ready and not give up also. What I’m afraid of also is that some, that we have notified bodies that are giving up and maybe now we’ll have some small manufacturers that will also give up because they say it’s too much. There is too much thing, and we don’t want to invest money, where at the end, we know that we will not make it, et cetera, et cetera because of the deadline, so–
• And that, sorry, to interject, Monir, but that is one of the concerns. I think, again, it’s me speaking, my opinion, but I think that these European regulation will change the shape of the European market, particularly, particularly for IVDs. The impact on IVD manufacturers will be much greater than medical devices because as you mentioned before, medical device manufacturers already were used to work with notified body. It’s not that they are totally facing a different environment. That will happen for IVD manufacturers. And that from what I’m seeing, honestly, our consulting company is very specialized in IVDs. We basically work with 70% of the top IVD players. So what I see for the moment, in a bullet statement, is that the big players, you bet, they are on it. They are already working since months, if not a year. And they are preparing very well. The small manufacturers, even some of the medium ones, they still have their head buried in the sand. And when they will wake up, for many of them, it will be dramatically too late.
• Yeah, and as you mentioned, there is, I think, a lot of diversity in terms of products. And there is some product that exists maybe only with some small manufacturers and not with big ones. So, losing them, we can maybe lose a big part of the products that people are using and–
• [Maurizio] Exactly.
• This is maybe risk for patients at the end. Also risk to have no competition so that only big medical device can dominate the market.
• Yeah, let me reframe that a little bit. I don’t think really risk for patient. The risk for patient doesn’t come from the fact that certain companies, small companies, won’t be able to offer their products, okay. I think that the risk for patients may come if the European Commission will not put in place these plan B mechanism, okay, that we were discussing before. If they will only apply a very, very strict mentality saying, hey, if you don’t have your MDR, Medical Device Regulation Certificate, you will not be able to place product on the market. If they take such a strict and rigid attitude, and they will take it by telling the notified body to take such attitude, really, there is the risk that certain medical devices, first, of course, because the deadline is coming earlier, and later …

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In-Vitro Diagnostic Regulation will come later and we have time. Maurizio Suppo do have another opinion and as he is really passionate about this topic he will be providing some golden advice that you should not miss. Even for non-IVD manufacturers as we will talk about a proposal if manufacturers cannot meet the deadline. The post New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo appeared first on Medical Device made Easy Podcast.

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Her nickname is the PMS Queen as she can tell you all you need to know about Post Marketing Surveillance. Natasha Bankowski, Head Regulatory affairs and Pharmacovigilance at Kora Healthcare will really deliver you a masterclass on this episode of the Medical Device made Easy Podcast.

Her advice on this topic are really important as Post Marketing Surveillance is changing a lot with the new Medical Device Regulation MDR 2017/745. There are now some PMS Report, PSUR, PMCF, and EUDAMED that also enters the game.

One important take from this episode is to see the PMS as process connected inside all you Quality Management System and not only as a separated tool. It collects data from so many processes that it is really important to be careful when you are building that for your organization.

Who is Natasha Bankowski?

Natasha has experience working in both the Pharmaceutical and Medical Device Industry for over 12 years. She has worked across multiple areas including Quality Management, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and R&D.

She has managed the Global Regulatory Affairs, Pharmacovigilance, and Medical Affairs Departments and has being successful in building the global footpath with registrations in over 150 countries.

She is currently working as the Head of Regulatory Affairs and Pharmacovigilance at Kora Healthcare in both the pharma and medical device space. She also lectures part-time in both Regulatory Affairs and Vigilance.

Links

• Natasha Bankowski Linkedin: https://www.linkedin.com/in/natasha-bankowski-0971ba28/
• Kora Healthcare website: http://www.korahealthcare.com/
• PMS Guidance for MDR 2017/745: https://ec.europa.eu/docsroom/documents/36292
• The episode on EUDAMED with Richard Houlihan: https://podcast.easymedicaldevice.com/25
• TOPRA Symposium 2019: https://bit.ly/2GVuDWs
• The episode with CEO of TOPRA on Networking at events: https://podcast.easymedicaldevice.com/39

The post Learn Post Market Surveillance with Natasha Bankowski appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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On this episode I invited Natasha Bankowski that is also called the PMS Queen to help us understand the Post Marketing Surveillance for Medical Devices. You can also meet her at TOPRA Symposium 2019. The post Learn Post Market Surveillance with Natasha Bankowski appeared first on Medical Device made Easy Podcast.

If you are really confused about Product Equivalence for your Clinical Evaluation Report or CER, then you are at the right place. Just hit the play button as Helene Quie from Qmed Consulting will be providing you some great information.

On this episode of the Medical Device made Easy Podcast, we will go through some specific aspect of Product Equivalence as:

• Clinical Equivalence
• Biological Equivalence
• Technical Equivalence

This master class regarding Clinical Evaluation Report (CER) will help you be compliant for the new Medical Device Regulation EU MDR 2017/745. The mindset of Notified Bodies changes so they will be stricter regarding clinical aspects to prove the safety of your product.

Who is Helene Quie?

Helene Quie has a degree in Science specialized within cell biology from the University of Odense. Helene has 20 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S.

Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access, and general management.

In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.

Links

• Qmed Consulting: https://www.qmed-consulting.com
• Qmed Podcast: https://www.qmed-consulting.com/podcasts.html
• MEDDEV 2.7/1 rev 4: https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native
• TOPRA symposium 2019 – October 1st and 2nd 2019: https://www.topra.org/TOPRA/TOPRA_Member/Symposium_2019/TOPRA_Annual_Symposium.aspx
• TCT – September 25th to 28th – San Fransisco – USA https://www.crf.org/tct
• OCT – October 22-23 – Copenhagen – Denmark https://www.arena-international.com/octnordics/

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The post Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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This episode with Helene Quie from Qmed Consulting contains Diamond of Information. If you are lost regarding Product Equivalence for your CER, then you need to listen that and it will be clearer. The post Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie appeared first on Medical Device made Easy Podcast.

Networking at events can seem really difficult. Saying “Hi” to persons without knowing them is a bit awkward. What is the objective of this approach?

If you are going to events to find new customers, to discover new technologies or to learn about the industry change, it is critical that you invest some time to research and prepare for it so you can maximize your return on Investment.

This is what Lynda Wight, Executive Director at TOPRA will help you understand on this episode. As an example, we will use the TOPRA Symposium 2019 to describe the situation.

This year, the TOPRA Symposium will be held in Dublin, Ireland – September 30th to October 2nd. If you have a moment during the breaks I’d be delighted to meet new colleagues and familiar faces at Booth 27 (RApport Global Strategic Services) where I will be discussing the transitioning of the MDR/IVDR amongst other topics!

Who is Lynda Wight?

Lynda Wight is a Fellow and Executive Director of TOPRA (The Organisation for Professionals in Regulatory Affairs), the international professional association for those in healthcare regulation. 

She oversees all TOPRA’s activities, which includes over 30 training courses and conferences annually, MSc and Ph.D. programs, professional registration activities, Awards, and a peer-reviewed journal.

She has a BSc(Hons) in Biological Sciences and an MSc in Information Science and started her career in regulatory affairs for Merck, Sharp, and Dohme.

She then helped establish a consultancy and training business which became the international CRO IBRD Rostrum Global of which she was Executive Vice President, Europe.

Links

• Lynda Wight Linkedin: https://www.linkedin.com/in/lynda-wight-4441a311/
• TOPRA website: https://www.topra.org
• Medical Device Symposium Programme: https://www.topra.org/TOPRA/TOPRA_Member/Symposium_2019/Programme_TOPRA_Annual_Symposium_2019.aspx
• TOPRA Symposium Booking: https://www.topra.org/TOPRA/TOPRA_Member/Events/Event_Display.aspx
• TOPRA Symposium App: https://www.topra.org/TOPRA/TOPRA_Member/Symposium_2019/Networking-2019.aspx

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The post Episode 39 – Networking at Medical Device events with Lynda Wight appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Networking at events can be a great experience or a disaster. On this episode we will help you to be prepared for it. We will use the TOPRA symposium as an example. The post Episode 39 – Networking at Medical Device events with Lynda Wight appeared first on Medical Device made Easy Podcast.