How to CE Mark a Medical Device
22-6-2020 Law and Legislation
Table of contents
What does a CE mark mean on medical devices?
Is the CE marking self-certification?
What does the CE marking process look like?
What are the benefits of having the CE mark?
What’s the difference between a regulation and directive?
What are the main differences between the old directive and the new regulation?
How to get CE certification for your medical device?
Step 1 of the process to CE mark a medical device: identifying the applicable directives/regulations
How to identity the harmonised standards for your medical device?
Where to find harmonised standards?
Step 2 of the process to CE mark a medical device: Determining the requirements and standards for medical devices
Step 3 of the process to CE mark a medical device: Determining the route to conformity
Step 4: How to test your medical device
Step 5: Compiling the technical file of your medical device
Creating the instructions for use (IFU)
Step 6: Drafting the Declaration of Conformity
Where can you sell your medical device?
How long does it take to CE mark a medical device?
What are the costs for certifying my medical device?
The future for medical devices
Ferry: Hi there and welcome to the show. In this podcast, we're going to talk about how to CE mark a medical device. As one of our specialisms is creating user instructions, or actually, I have to say instructions for use or IFU, for medical devices, many of the clients for whom we create user instructions are involved in the certification process of medical devices. Because the old medical device directive will soon be replaced by the new medical device regulation, medical devices are a hot topic at the moment. With the instructions that we create, we help provide clear information on how to use a product which is necessary for using a product safely, efficiently, and effectively. We make sure that our instructions are user-friendly, appealing, and comply with legal requirements. As I think, it is useful for companies selling medical devices on the European market to have more insight in the certification process of medical devices, we will talk about this in this podcast episode. We hope to provide practical tips on how to go through the CE marking process and self-certify or certify your medical device. In this podcast, we will discuss the process of CE marking in general, how to identify if your product is a medical device and which class it is, which steps to follow to obtain the CE mark, and how to register your medical device. Our expert of today is Martin de Graaf. Martin is a consultant for the company Certification Experts. Martin is responsible for assisting companies with the conformity assessment procedures of medical devices. He specialises in offering guidance on product qualification, indicating the correct conformity assessment route to be followed, evaluating technical documentation, and offering guidance on implementing a certified quality management system. Besides European market access for medical devices, he also supports companies with access to the Chinese and American markets. Welcome, Martin.
Martin: Thank you, Ferry. Good to be here.
Ferry: Let's dive into it, Martin, directly. I have a question to start with. What is the most interesting project you were involved in, and why, related to medical devices?
Martin: There was a project which is -- it may seem to be a quite easy device, but often, the most easy devices are the most complex devices in a sort of way, basically because it's always a good invention. There was an easy device basically to count the number of inhalations of an inhalation device. Basically, it was quite interesting to navigate the company through the entire process and to ensure that they comply with all the requirements as they basically invented a new product. That's always something that is, I think, it's still quite amazing to be part of the job that you're really close to practical inventions.
Ferry: Thanks for that Martin. Let's talk more about how to CE mark a medical device. First of all, Martin, what does the CE mark mean on medical devices?
Martin: It's a French term, but basically, it means that the product complies with the minimum requirements for medical devices within the European Union. Basically, this means that in order to put the product onto the market, there are minimum requirements that need to be complied with, and that's the CE mark. It's not something that is commercial; it's legislation, it's law, and it's mandatory to CE mark a medical device.
Ferry: Right. Do all medical devices need to be CE marked?
Martin: That's an interesting question because normally I would say yes, all medical devices need to be CE marked, but there are some subcategories of devices that need to comply with certain requirements but they cannot be let's say CE marked. Part of that may be custom made devices as they are custom made for each and every patient. There are still requirements for these devices, but they are just different basically than other requirements, other devices.
Ferry: They're basically an exception from the medical device directive.
Martin: Yes and no, because they still need to be safe. They still need to be effective and they still need to comply with certain requirements, but the CE mark itself may not be applicable.
Ferry: Let's say I have a medical device and it needs to be CE marked, you often hear CE marking is self-certification. Can I conduct the CE marking myself, or can I follow the process myself?
Martin: Yes, you can, but that depends upon the device that you have because the devices are categorised in different classes, and there's a different procedure to obtain the CE mark for the different classes. The most simple devices with less risk, they are eligible for self-certification. That basically means that no third party is required to check any documentation.
Ferry: Can you tell me a bit more about the process you need to follow when you self-certify or certify your medical device?
Martin: Sure. The process basically remains the same. If we're talking about some of the steps, first, you need to identify your device and you need to ensure what kind of legislation is applicable to your device, and that will also indicate that the device is a medical device. Then the classification is also important because if the device is a medical device, then you need to classify it accordingly with the legislation. Basically, the product needs to comply with the essential requirements, so these are a list of requirements that apply to every medical device, and after that, the conformity assessment procedure needs to be identified. Sometimes you have a choice as a manufacturer to choose a certain trajectory and conform to your assessment procedure, sometimes you do not have a choice, but it is good to identify which procedure you need to take to get your products CE certified. When you have identified the conformity assessment, you need to conduct a conformity assessment. In that step, actually, the classification of the medical device is very important because how to carry out the conformity assessment procedure varies for the different types of classes of devices. What is always a requirement is that certain technical documentation needs to be drawn up and the technical documentation is the documentation that proves that the device complies with the requirements. Basically, in short, if you have done all this and this is just a brief overview, then you can affix the CE mark onto the product and you can register the product in order to bring it onto the European market.
Ferry: Thanks for explaining that. If I understand you correctly, then let's say I'm a manufacturer of a medical device, then I, with help of a third party in some cases, need to follow these steps of the CE mark process for medical devices. Is that correct?
Martin: Yes, that is correct.
Ferry: When I follow these steps and, at the end, I affix the CE mark to my medical device, I know for sure that my medical device complies with all the requirements from the directive or regulation, what are the benefits of having this CE mark?
Martin: The CE mark, if you're bringing a medical device into the market, a CE mark is actually not a choice because it's a legal obligation, but having the CE mark on your product, you know that the product complies with the base rules that basically are applicable for medical devices in Europe, you comply with the base safety rules and you know that your device can be used in a safe way.
Ferry: As a manufacturer then, I know after having applied the CE mark that I am selling a safe product.
Martin: Yes. Sometimes you also need to check whether-- Sometimes it is inevitable that there are certain risks with a medical device, but the benefits will always outweigh the risks. At least if you have followed the procedure correctly, then you can only bring safe products onto the European market.
Ferry: Meaning that the end-user or the user of a medical device is guaranteed or is quite sure that the medical device is safe or at least meets the requirements from the European Union?
Martin: Yes. Basically, if a consumer sees a medical device with the CE mark, then he needs to trust on it that the device complies with the safety regulations counting in the European Union.
Ferry: Isn't it enough of a benefit that as a manufacturer, I can sell my product or my medical device within the entire European Union?
Martin: Yes, that's definitely a benefit of the CE mark because that's also, of course, what the whole CE mark and its intention was because the European Union, of course, is one market, so they tend to harmonise the requirements, and if you comply with the requirements for the CE marking or for, in this case, the medical device directive, then you also comply with the minimum requirements for each of the member states. If you have the CE mark, you can sell your product in all of the member states of the EU.
Ferry: Thanks for explaining that, Martin. Let's talk a bit about regulation and the directive because at the moment we're recording this podcast, this episode, the old, so to say, medical device directive still applies, which is the 93/42/EEC medical device directive. However, I think it's like this month actually, the new medical device regulation was about to replace this directive, is that correct?
Martin: Yes, that is correct. Actually, we are recording it upon the day of which the medical device regulation would go into force. However, due to the current situations in the world and the pandemic, the medical device regulation is postponed for about one year. So it will be enforced next year on the 26th of May 2021. This year, we're still dealing with the medical device directive.
Ferry: Right. What a coincidence. I didn't know that [laughs] . Can you tell me a bit more about the differences between the regulation and the directive? Maybe first of all, what's the difference between a regulation and a directive in general?
Martin: From a legal point of view, a directive is a law that is made basically by the European Union and the law applies to all of the member states. However, all the member states need to implement the law into their national system. This means that, for example, the medical device directive is implemented in, let's say, the Dutch law, and if you as a Dutch citizen would need to go to court to get something from the law, let's say, then you need to refer to the Dutch law, and for a regulation, that's also a law that is made by the European Union, however, that's directly applicable to all its citizens. So you can directly quote and refer to the regulation and it's immediately in effect, and there's no need for implementation in national legislation.
Ferry: Meaning that the process before a regulation becomes law is shorter than in the case of directives, or is that can't you say?
Martin: Yes, that is something that you can say. However, it is just meaning that the law indicates minimum requirements and it's just easier basically for a regulation as it can be enforced for all of the EU citizens. Otherwise, you need to have the national legislation to have it enforced, and there could be some changes in there or additional requirements or anything like that.
Ferry: Thanks for explaining that. Let's go to the beginning. I think you indicated, one of the first things in the CE marking process for medical devices is identifying the applicable legislation for the medical device and you have to classify the medical device and as far as I know that's something that really distinguishes medical devices from other products that fall under the scope of CE marking. First of all, is that correct? Is that like a real distinguishment of medical devices classification?
Martin: Yes, in a sort of way, because basically, for all legislation, and we are dealing with definitions, we need to ensure also in other pieces of legislation that the product complies with the definition indicated in law to ensure that the law is applicable to that product. For medical devices, the definitions are broader and more specific. It's, let's say a more specific piece of legislation to ensure that your product is applicable or the legislation is applicable to the product.
Ferry: Okay. Does this classification change in the new regulation or is it more or less similar?
Martin: It changes. It doesn't change a whole lot, but it could occur that some of the medical devices that are let's say, a Class I or a Class IIa medical devices scale up one classification in relation between the medical device directive and the medical device regulation. That's also a good thing for our listeners to take into account. If you already have a product onto the market, check whether the classification changes due to the new regulation.
Ferry: With scaling up, you mean that it becomes more regulated?
Ferry: Right. It doesn't become easier?
Martin: No, but in a way, you can always say that if it's more regulated, then maybe it's become safer.
Ferry: Absolutely, and your competitive advantage becomes better.
Martin: Yes, exactly.
Ferry: What are other main differences between the old directive and the new regulation?
Martin: There is a new category of devices that are indicated in the new regulation as medical devices that were not explicitly mentioned in the old directive. Basically, what we're talking about, one of the definitions of a medical device is that it needs to have a medical purpose. There have been a lot of discussions about some devices that were new into the market that did not have a medical purpose, but they were quite similar to medical devices. Now there is a specific Annex, that's Annex XVI of the medical device regulation that lists products that do not have a medical purpose, but they are medical devices. An example of those products are, for example, dermal fillers, infrared treatment devices, or even contact lenses, products like that.
Ferry: A contact lens wasn't classified as a medical device in the old directive and is a medical device in the new regulation?
Martin: A contact lens was also a medical device. My apologies. This is merely for the coloured contact lenses because they do not have a medical purpose because normally you have a contact lens and the medical purpose is to improve your eyesight. If you have a contact lens for a coloured lens, let's say, and you do not have a medical purpose but you wear it basically for aesthetic reasons, and in the regulation, that is classified now as a medical device.
Ferry: Right. Are there any other main differences between the two?
Martin: Between the medical device regulation and the medical device directive you mean?
Martin: There are some differences. Basically, they tried to more tighten basically the procedures meaning that there were some requirements that were still required in the medical device directive but there will be more active surveillance by the market authorities, let's say, to check up on those requirements to ensure that all the manufacturers are remaining in compliance. So there's a new system basically to create the whole traceability and for the checking of the documentation and compliance and medical device regulation is more extent and covers more definitions, basically, so it's more clear.
Ferry: The new one?
Martin: Yes, it mentions more explicitly what is required, what are the documentation requirements? For example, what are the definitions? What are the obligations for manufacturers? What are the obligations for importers? Those things are more explicitly mentioned in the new regulation.
Ferry: Is there a different conformity procedure you need to follow for the different medical device classes?
Martin: Yes, there is a different procedure to be followed. Basically in the beginning, we were talking about self-certification. Is that possible? That is possible with the lowest risk class, and the risk classes basically go up from Class I, Class IIa, IIb, and then Class III. If you're having a Class I medical device, then you need to ensure yourself as a manufacturer that the product complies with the requirements. If that is the case, then you can register the product and put it onto the market. If you're having a medical device in a higher risk class, then a third party assessment also is applicable. This is done by a notified body because they are companies basically accredited to assess products and product systems in accordance with the legislation. What they actually do is they will do a CE certification check, "Okay, you have the documentation drawn up, is the documentation correct? Have you complied with all the requirements? Do you have a quality management system to ensure that every product that you make, that you produce is of the same quality and it meets the requirements indicated in the legislation?" Basically, for the last one, the quality management system, they will also do yearly audits to ensure that this is all done.
Ferry: Does the notified body-- do they follow the requirements as indicated in the legislation, let's say, as indicated in the directive or in the regulation, or do they apply harmonised standards in order to conduct the audit, for example?
Martin: They do a combination of both because they will follow the legislation. Let's say their ground zero is the legislation, they will always fall back on the legislation, but the standards can be used to ensure that the legislation is met. For example, if you'll need to have a quality management system, the legislation will indicate the manufacturer will need to have a certified quality management system that will need to comprise the following elements. There is a standard, that's the ISO 13485 standard. That is about quality management systems for medical devices. If you have a quality management system set up in accordance with that standard, then your quality management system complies with the requirements indicated in the legislation. So what the notified body will do is they will take the standard and will check whether the quality management system complies with the standard.
Ferry: Clear, but in order to determine if you need a notified body, if you need a third party, third party testing, you need to make sure that you know the class of your medical device.
Martin: Yes, that's the absolute essential element. You need to know the identification of your product, you need to know whether it's a medical device and you need to know the classification.
Ferry: How do I know if I have a medical device? Let's say I'm selling a product, but I'm not sure If I have a medical device or not.
Martin: That's a very interesting matter because basically what manufacturers do is when they have a product, they need to establish the ground rules, "Okay, so I have this kind of product, what legislation is applicable to this kind of product?" Sometimes it's quite easy because if you're selling a product that is already onto the market, then you can, let's say, steal some ideas and know, "Okay, so I need to comply with this kind of legislation." If that is not the case, then you just need to check what kind of legislation is applicable in that country. Does my product fall under one of these laws? If so, I need to follow that law. That is basically the simplified version.
Ferry: You're saying you have to check what legislation applies to that country, but then you're saying you're checking it very country-specific and it's not like European?
Martin: That's a good remark. Because basically, what I mean is when I'm talking about a specific country and I'm talking about requirements for the European Union, as it's one whole, I'm talking about the European Union as a country.
Ferry: As a country, so you have to check whether you're selling it within the European Union or not.
Martin: Yes, correct.
Step 1 of the process to CE mark a medical device: identifying the applicable directives/regulations
Ferry: Let's take a step back and make it really practical and go through the steps in order to CE mark a product. Let's say, I'm a manufacturer of a medical device, for example, a pacemaker, where do I start? How do I CE mark such a medical device?
Martin: First, what we just indicated, a pacemaker is very-- it's not a new device. There are a lot of pacemakers already on the market.
Ferry: Is it a medical device?
Martin: A pacemaker is a medical device, yes. That is something that you can work with. First, you need to indicate what are the specifications of the product. If you know it's a pacemaker, and if you know it's a pacemaker which is intended to aid people, basically, with our hearts, and then you know, basically, it's a medical device. You need to check the legislation on medical devices. It's not like a checklist that you need to get from the top to the bottom. In general, for pacemakers, you need to know that it might be a medical device or you need to take into account the legislation. What you do next is then you check on the definitions, "Okay, what is the definition of a medical device? Is that something that applies to my pacemaker?"
Ferry: The definitions are mentioned in the directive or in the regulation?
Martin: Yes, that is correct. In one of the first articles, the definitions are mentioned, and for example, for a medical device, there are some requirements. As I indicated, it must have a medical purpose. It needs to be used on human beings. It needs to have an intended medical purpose and it's intended to be used on human beings. In this instance, let's say that it helps in the process for a disability. If you have some heart rhythm problems, let's say, then it helps with a certain disability. In that case, you can identify a pacemaker as a medical device.
Ferry: Okay, and you're saying you have to check the definition, but where can I find the regulation or the directive?
Martin: They are freely available. You can find them online. You have the website of the European Union, basically, EUR-Lex (https://eur-lex.europa.eu/homepage.html). On that website, you can identify the codes for the legislation. You can then retrieve the PDF files of the laws. As you mentioned earlier for the medical device directive, that's the directive 93/42/EEC and the medical device regulation is the regulation (EU) 2017/745.
Ferry: I'll put the URLs of EUR-Lex websites in the podcast transcription so the listeners can find those directives and regulations. Then you can download the PDF, and there you can check the definitions, right?
Ferry: The next step, but I think it's still step one of the certification processes, is how do I know to which class my pacemaker belongs?
Martin: Yes, that is correct, because obviously, medical devices is a very broad term. If we're talking about a pacemaker, you're talking about something very different than let's say, a Band-Aid or something like that. So if you know that your product is a medical device, then you also have the classification rules. The classification rules are mentioned in the annex of the legislation. From top of my head, it's in the medical device directive, it's Annex IX, and in the medical device regulation, it's Annex VIII. Basically, what that annex indicates, it gives certain rules, and it says, if your device is a non-invasive device, non-active device, then it falls in this class. Basically, you need to follow the rules. You need to rule them all. You only need to find the rules that are applicable to your product. In that way, you can identify the classification of your products.
Ferry: Thank you. That's something you can do yourself, or do you need some knowledge about medical devices, classifications, et cetera?
Martin: That is something that you can do yourself because there's also a few definitions mentioned in that annex for you to do it yourself. Obviously, you can also ask a consulting company to assist you with that. Because basically, that's a lot of the work that they are always doing on a daily basis. I understand that not everyone is working with the medical device regulation and directive on a daily basis.
Ferry: Those are all legal texts, so you have to understand those directives and regulations as well.
Martin: Yes, that's correct.
Ferry: We talked about directives, about the new regulation, but then there's also something like standards or harmonised standards. Do I need to identify the harmonised standards as well in this first step of the CE marking process? Is there a CE mark medical devices database?
Martin: Yes, the harmonised standards, they're basically tools for you to know how to design, how to test your medical device. It's very helpful to also identify them in the first stage. What you can do for this is basically to-- The European Commission has a list of the harmonised standards that are applicable, while they are harmonised under the medical device legislation, and if you have a standard that your product complies with, let's say, or there's a standard for a specific product, then there's a lot of useful design information, testing information that can help you comply with the legislation that will definitely help you with the next steps.
Ferry: A standard helps you to comply with legislation, with the requirements from the regulation or directive.
Martin: Yes, that is correct.
Ferry: You can apply a standard, but it's not a mandatory thing to do.
Martin: It's not a mandatory thing to do. Basically, to give you a small example, let's say you're having a syringe, you would like to market your syringe. The legislation cannot indicate for every certain product type, what the specific requirements are. You read the requirements, and basically, it says, "Okay, the operation of the syringe must be safe." You're thinking, "Okay, the operation must be safe, but in what way does it need to be safe?" If there's a harmonised standard for syringes, that's a technical document, basically, that is written specifically for syringes. So it will indicate if you use, for example, this design, or if you use this material, or if you use this procedure, then your product is safe, so you can use the standards to comply with certain requirements.
Ferry: But then your advice would always be to take notice of any available standard's an advance , so before you start developing a product, a medical device, and use those standards in order to create, develop a product that meets the requirements from the directive or regulation?
Martin: Yes, that's always the best way to start the process.
Ferry: But in daily practice, I speak with companies that are, for example, importing medical devices. They say, "Yes, but our manufacturer says that it complies with these standards."
Martin: That happens a lot indeed.
Ferry: When they're drafting up the declaration of conformity, they're asking, "Hey, which standards should I mention here?" Then my answer would be, "Well, the standards that you use during your development process," but then the answer quite often is [laughs] , "I'm not aware of any standards that we use."
Martin: Exactly. That is something that we also experience in the practice quite a lot. It is essential basically to know what their requirements are for your products on an early basis. If you know that the standards can give you additional information, then it will make the whole process a lot easier if you identify them in an early stage.
Ferry: Exactly. You can see the standards as a design tool actually for your product but also maybe for your documentation for other requirements?
Martin: Yes, that is correct.
Ferry: We've identified if my pacemaker is a medical device. Yes, it's a medical device. We've identified the class of the medical device. What was the class again?
Martin: For a pacemaker, that would be a Class III medical device. That's the highest risk class. That's basically because you can imagine that if a pacemaker is not safe, if it's malfunctioning, that could cost lives, so it's a very essential part of the human body basically. That's all taken into account in the classification of the product.
Ferry: All right. My pacemaker is a medical device. It's a Class III medical device. The medical device directive applies or the medical device regulation applies. Maybe there are some other directives or regulations that apply to the product?
Martin: Yes, that could definitely be possible because if you're talking about a pacemaker, you're talking about an electrical device. It may occur that some other legislation is applicable, but then it's always a good thing to check whether the other legislation also indicates certain requirements or that these requirements are already embedded in the medical device legislation. That's also something that you need to be aware of when selecting the applicable legislation for your device.
Ferry: Do you have an example of legislation that has been embedded in the medical device regulation already?
Martin: Let's say if the low voltage directive is also applicable to electrical devices, then it's also embedded in the medical device legislation that a product that is active and is dependent upon electrical current should be safe. There's an overlap of requirements in that area.
Ferry: Meaning, for example, let's say I'm a manufacturer or an importer of breathing devices, quite actual with the corona crisis at the moment, and this meant a breathing device can be connected to a mains socket or needs to be connected in order to function to a mains socket, then the low voltage directive applies, but it's embedded in the medical device regulation already?
Martin: Yes, that is then correct because I think for breathing devices, there are already some harmonised standards that would explain in ultimate effect, how it would need to be designed to be in accordance with the electrical requirements. You can indicate that the low voltage directive, for example, is also applicable however the requirements could already be taken up into the medical device regulation or directive.
Ferry: You're saying there might be some harmonised standards for breathing devices. Where can I find harmonised standards? Is there a list available somewhere?
Martin: Yes, there's a list of harmonised standards that is provided by the European Commission. There's a good list that indicates, "okay, so, what kind of legislation are we talking about," so you can select all kinds of regulations or you can select all kinds of directives, and they give you a list of standards that are harmonised. Obviously, there are more standards. However, the standards that are not harmonised are not on that list.
Ferry: The European Commission only lists harmonised standards but possibly when I go to the website of the British Standard Institute or maybe or the DIN in Germany and NEN in the Netherlands then it may be possible that I find more standards than only the harmonised standards.
Martin: Those standards can be useful because the standards are often used to know what kind of technical specifications there are at the moment but it always takes time for standards to be harmonised and not every standard is harmonised. That's basically the difference if you're finding let's say a standard on the British Standards Institute website but you cannot find it on the website of the European Commission.
Step 2 of the process to CE mark a medical device: Determining the requirements and standards for medical devices
Ferry: Right. Thank you, Martin. That's enough information about step one. I would suggest we go to step two of the CE marking process for medical devices. Are we ready for this already?
Martin: I think we are. [laughter]
Ferry: What will be step two?
Martin: To identify the essential requirements that are applicable for your medical device.
Ferry: I want to understand you correctly, not all requirements are applicable to all medical devices?
Martin: Yes, you are absolutely correct because if we're looking at the medical device directive or the medical device regulation, there's an annex, and in both, it would be Annex I. It gives a long list of essential requirements. That list basically indicates the requirements that medical devices should comply with. The essential requirements are categorised. Meaning that, for example, there's a section about active medical devices. Those are the medical devices that depend on electrical currents or something like that which means that if we're talking about our pacemaker, that that section is applicable. However, if we're talking about Band-Aids, that section may not be applicable. There are specific sections that are applicable to your medical device and specific sections that are not applicable to your medical device. You need to basically list the requirements that are applicable to your medical device. Then you can take into your process how you are going to comply with them.
Ferry: Actually as a manufacturer I need to read the directives or the regulation and determine which parts apply to my product?
Martin: Yes, correct.
Ferry: That's it in step two?
Martin: Basically, yes, but it's quite extensive also to know how do you comply with certain requirements. Obviously, that is something that is applicable also for the next steps when we're talking more and in-depth about the conformity assessments, but in essence, step two is to identify all the essential requirements that are applicable.
Ferry: Okay. You have to know how to comply with a requirement? Is that something that you can determine yourself or--?
Martin: Yes, that is something-- basically you can identify standards that can be used for those kinds of things, but it can also be that you have done some other test yourself, let's say, and if we're talking about examples in this case, then it could be that if your product needs to be electrically safe, let's say, that's quite a general requirement. If you are having your product tested in accordance with the harmonised standards that also takes into account electrical safety, then you can use the results of that to prove the compliance with that requirement.
Ferry: Meaning that you can use harmonised standards in order to prove that?
Ferry: For example, when I'm not sure if it's a requirement, one requirement would be the device shall not contain any sharp edges, maybe you don't need the standard to--?
Martin: No, exactly. There are two ways. Either you don't need a standard or you have used a standard with some let's say design specifications because if that standard is then harmonised and you refer to the design specification, then you can indicate that you comply with certain essential requirements. However, if we're talking about this specific case, then my advice would be to document an assessment that you did on the product itself to determine that the product does not have sharp edges. An assessment basically to check whether the product has sharp edges can be embedded in the quality management system. If you, sample-wise, check the products that come out of the factory, then you can basically do a check that all of the products coming from the factory whether they still have some sharp edges or not.
Ferry: Right, but we're, I think we're talking already know about the conformity assessment procedure, which is, if I'm correct, the next step of the CE marking process?
Martin: Yes, I'm just being one step ahead of myself, but I was just explaining how it can be proven to comply with certain essential requirements.
Ferry: Okay, thanks. In step two, we determine the requirements and possibly the standards for medical devices. When we've done so, we can go to step three?
Martin: Yes, we can. I think that's a good thing.
Ferry: Which is?
Martin: The conformity assessment procedure and basically selecting a conformity assessment procedure. That's also something that you have the classification of your device. Basically, the classification of your device also tells you what kind of conformity assessment procedure you need to conduct.
Ferry: Whether you need a notified body or not is determined by the class of your medical device?
Martin: Yes, so then you need to know if contacting a notified body and having an assessment carried out by a notified body is part of the conformity assessment procedure.
Ferry: You've already mentioned a few different assessment procedures. Can you give the full overview of different available procedures?
Martin: Well, I can at least try. They're talking about different modules, let's say, in the legislation, but in essence, in most practice, it comes down to this. If you're having a Class I medical device, then you need to ensure as a manufacturer that your product complies. If your product complies, you can bring it onto the market, after you have CE marked it, of course. If you are having a Class IIa medical device, then you need to also have an assessment carried out by a notified body, which means that you need to have your technical documentation in order, and you need to have a quality management system implemented. Both those things will be assessed by the notified body. The notified body will do a desk review or a desk assessment of the documentation and will need to check whether all the documentation is present and whether there is enough proof to prove that your product complies with the legislation. They will also need to certify the quality management system that is used to produce your product. For that, they will do an onsite audit, and they will also do repeat audits, let's say, once every year.
Ferry: As we're talking about the pacemaker as an example, you mentioned that the pacemaker is a Class III medical device, so it does need testing by a notified body?
Ferry: Does that mean that they take over the full testing of the product, or is that still something that I as a manufacturer need to do myself?
Martin: There's still something that you need to do yourself as a manufacturer. The notified body does not always do specific testing. They could in a certain module test and review every product, but when you are talking about series production, that's highly inefficient. In this case, basically what they will do is they will check the documentation and issue a certificate if the documentation is in compliance. They will also check the quality management system. However, when we're talking about a Class III device, the notified bodies will act with more caution and will ask for more information, so the general overview of the requirements remain the same, of the documentation requirements. However, it needs to be more in-depth in the case there are more risks to the product, and there needs to be some additional safety features to make sure that they comply.
Ferry: I have a Class III medical device, I know that I need to notify the body for certain parts. I have to conduct some parts myself. In step three, I have determined the route to conformity?
Ferry: Then the actual testing needs to be done, which is most likely step four.
Martin: Yes. The testing is then part of the documentation, really, and when you're thinking about the technical documentation that encompasses quite a lot of aspects, but also encompasses test reports. Let's say if a notified body will check your technical documentation, then you will also need to already have some test reports in accordance with certain standards. There is a separate route that you can take when a notified body basically examines every individual device. That's not a route that is often taken as it's highly inefficient when we're talking about products that are manufactured in series.
Ferry: For medical devices, is a risk assessment mandatory, or is that actually the conformity assessment itself?
Martin: Risk assessment is mandatory, and there's also a standard for that, basically, for risk management. That's the ISO 14971.
Ferry: Which is a standard specifically for medical devices or for general, for all the products as well?
Martin: That's specifically for medical devices. Basically, risk management is quite important as we always need to check what are the risks of the device, and how does the risk influence basically the patients or the use or anything like that because obviously if you're talking about the medical device, most of the time it's used to improve the situation of a certain patient. It could be that there are risks. However, if the improvements, if the benefit is higher than the risk, then that's okay, and that's basically with all products in the EU. There always is a risk. You cannot take away the risks completely. There's always a risk, but it needs to be acceptable.
Ferry: The machinery directive also requires conducting a risk analysis, and for machinery, well, you can follow the ISO 12100, if I'm correct, which is how to conduct a risk analysis for machinery. I do know that this ISO standard 12100 talks about three ways of reducing risks. First of all, when there are certain risks related to the use of the machinery, as a manufacturer, you have to make sure that the design becomes more safe. It's not always possible to make a 100% safe design. Then there's a second stage for reducing the risks, which is providing safety measures, but still, then there can be risks related to the use of the machinery. Then the last step, in order to reduce the risk, is by providing instructions for use. Is that something that this standard for risk analysis for medical devices describes as well, this order in order to reduce the risks?
Martin: I'm not sure if it's specifically mentioned. The order and the process that you described is a very good process to use in general for all kinds of risk estimation, risk reduction processes, because basically it just counts down to what is most effective. Ensure that the design is safe. If that is not possible, then you need to do some other mitigation, and if you have done everything that you can, you need to inform the patients or to consumers. I'm not quite sure whether it's mentioned directly in the standard, but it's a good way to look at it, yes.
Ferry: This risk analysis, because we're talking now a lot about the risk analysis, my bad, but is this part of the conformity assessment? In other words, is this part of the testing or is this more part of the technical file?
Martin: It is more part of the technical file. It's something that remains basically a live document as we go, because there's always-- let's say there's a design change, then this could have an impact on the patient, and this could impose, let's say, a new risk. It's a document that is part of the technical documentation, and you need to also have it checked with the notified body. If we're talking, let's say, about the pacemaker and the notified body does an assessment on the documentation. However, it remains a document that needs to be updated if there are any updates or changes on the device. We can put it into basically the cabinet of the technical documentation, but it floats around between the certain steps.
Ferry: So you go back and forth between the notified body, compiling the technical file, et cetera until everything is complete and meets the requirements?
Martin: Yes, that is correct.
Ferry: In step four, so let's say we've determined the route to conformity, we know that we do need a notified body or not. We conduct the conformity assessment, we do the testing, and the result of the testing can be a report, for example, by a notified body saying whether a medical device complies or does not comply. Is that correct?
Martin: Yes, that is correct. Specifically, if you're talking about test reports, there are always requirements against which have been tested. Basically, if you have a report, that's perfect proof, that's basically your record, or if you're indicating that a product complies with, let's say a certain standard because the report indicates that the test has been carried out in accordance with the standard and that the product complies, and then the report is also part of the technical documentation.
Ferry: It's your evidence?
Ferry: If the market authorities, for some reason, knock on your door or something might have happened and they say "okay, give me your technical file," then they'll check if the reports do comply or the tests have been conducted in accordance with the requirements, et cetera?
Martin: Yes, that's correct. More specifically if they indeed indicate, "okay, we've had a complaint" let's say from the market, let's say the product is not waterproof to a certain extent and you have done your IP tests and you have an IP value on your product and you have the test report for that, then that is a piece of evidence that you can show them, "okay, we have done these tests and this was the result and it's done by an accredited laboratory, and we can ensure that's not a structural thing, that it may happen once, let's say, but it's not that the product does not comply with these requirements."
Ferry: Are you saying that the market authorities can also request your technical file when there is a complaint from the market?
Martin: Not really like a complaint, but there needs to be some sort of issue. Something must have happened, and if something happens, then the market authority can get the order to examine this and to review basically the documentation or to request certain pieces of documentation.
Ferry: Like something happened like an accident, for example?
Martin: Yes, that could occur.
Ferry: Then we've conducted all the testing, we've gathered the evidence that the product complies with some or most of the requirements from the regulation or directive. In the next step, then we have to?
Martin: Basically, to compile all the documentation together, you have all these separate points of evidence. You need to compile them into one file, let's say, and in the case of a notified body involvement, all these documents have been checked. This is your technical documentation. You just put it in, let's say figuratively speaking, into one folder, and that is your file, and that is also then including the certificates that you have received from the notified bodies when their involvement has been required.
Ferry: Earlier, you said that the new regulation is more clearly about what needs to be in the technical files than the old directive is. Is that correct?
Martin: Yes, that is correct. If we're just talking about the length of pages, let's say, then I think in the medical device directive, you have one page indicating these are the contents of the technical file, and in the medical device regulation, there's a more extensive list and certain items are split up to ensure that it is more easy to gather all the information.
Ferry: Besides the testing reports, what else should be included in the technical file for medical devices?
Martin: As you've indicated earlier, the instructions for use (IFU), that's an important thing. We also need to have some general information about devices. That could mean identification of the model numbers, the dimensions of the product, certain specifications such as voltage range, pressure range, things like that, the drawings, the information for the users, also meaning the labelling and the packaging, the information to ensure that the product is safe. Let’s say a clinical evaluation report that indicates that the product is indeed safe and also does what it intends to do.
Ferry: What is the clinical evaluation report?
Martin: A clinical evaluation report basically means that you have done an investigation on whether the product is safe and efficient. Basically, it says that if you can have a product that is completely safe, but if you say that it's a product that will help you to walk again, let's say, and it does not, then the product can be safe but it is not effective, and that is something that you check in the clinical evaluation.
Ferry: It's something different than the conformity assessment. Then you're checking if the product meets the requirements, but in clinical evaluation, you're checking whether, well, the intended use of the product meets the description of the intended use.
Martin: Yes, and basically I think the most simple example to give is clinical trials. Everyone has heard of clinical trials. They're often used in medicines. What they do is basically to check we have produced the product, is it effective? In clinical trials, it is a very scary thing in the medical device world, but this clinical trial is not always required to actually conduct a trial in the clinical evaluation phase. The clinical evaluation report can also be drawn up in accordance with desk research and other investigations that have already been carried out, let's say on the general scale in the past, but it's the combination of that information that will provide you with a clinical evaluation report that will say, okay, this is the product, the product is safe. It complies with the requirements, and it’s also effective so it does what it’s intended to do.
Ferry: You mentioned that the instructions for use need to be part of the technical file as well.
Martin: Yes, that is correct. It's also part of the technical documentation. For medical devices that are really simple devices, it's not always required to have instructions for use. If they can be used safely without instructions for use, and that's something that the manufacturer then should approve.
Ferry: When a product can be used safely without instructions, then you can determine not providing any instructions for use with it.
Martin: Yes, and that's only for the low-risk class medical devices.
Ferry: Right. I know that, especially the new regulation for medical devices contains an extensive list of requirements on the instructions for use.
Martin: Correct. That makes it quite better to know what are the items that need to be implemented in the instructions for use. You can follow that list, but there are also some other requirements that may apply. Then we're just talking about maybe there are some requirements from standards, or there are some requirements coming from the risk assessment of the device.
Ferry: Yeah, so you're saying there is a list, I think it goes from A to Z, and maybe even more requirements on the instructions for use. You have to make sure that your instructions for use comply with those requirements from the regulation or from the directive. Additionally, there may be requirements in harmonised standards.
Martin: Yes, that is correct. It may be because, as we talked about it before, the harmonised standards are more explicit on a product level. It could occur that certain information for certain devices is required and is indicated in the standards.
Ferry: As we're still talking about the pacemaker, it can be that there is a harmonised standard for pacemakers describing the requirements for the instructions for use which are additions to the medical device regulation or directive.
Martin: Yes, for pacemakers, I do not have the standards that are applicable for pacemakers from the top of my head. I do not know them by heart. It could be, for example, the regulation indicates that any additional warnings or something like that should be mentioned in the instructions for use. A more specific definition could be given in the standards indicating that when you have a pacemaker, you need to be careful with electromagnetic fields or anything like that. That is something that could be mentioned in the standard that could have an effect on the product and that should be instructed basically in the IFU.
Ferry: Yes, exactly, and so most likely products emitting radio waves, for example, need to have certain safety instructions, products that are so called in-vitro. Devices have different standards, and so different safety instructions that you need to provide with the product.
Martin: Yes, correct.
Ferry: Blood pressure monitors most likely is a different category, for example. Then what I always like to mention, to point out when we create our instructions for use so yes, you have the requirements from the directive or from the regulation. Then there are these so-called vertical standards, so you have to know, "okay, this is my product. Let's see if there are any harmonised standards specifically for my product category." Then there are the so-called horizontal standards and can be horizontal harmonised standards like the 82079 standard, for example, which is a standard to create user instructions in general. In order to make sure that you're creating safe user instructions, you need to apply the requirements from the directive or regulation, you need to apply the requirements from the vertical standards, and you need to apply the horizontal standards, like the 82079, or the ISO 20607 for machinery, which is, by the way, not a horizontal standard but a vertical standard. That’s just a side note.
Martin: Just a small side note. [laughter]
Ferry: We’re compiling the technical file. You said there is a clear list, well at least in the regulation, identifying what should be in the technical file. Then we can go to the last step of the CE marking process.
Martin: Yes, that is correct. That is affixing the CE marking and the registration of the device.
Ferry: With affixing, you mean putting the CE mark logo on the device.
Martin: Yes, and basically the legislation indicates it as affixing the CE mark because that's still, let's say, a physical thing for a manufacturer to do. Once he applies the CE mark onto their product, then the whole outside world knows that the product complies with the legislation.
Ferry: When you've done so, then you're declaring that your product complies with the legislation, and then the very, very last step would be that you draw up the Declaration of Conformity.
Martin: Yes, and what happens often in the conformity assessment procedure, is that, for example, if a notified body is also present for the conformity assessment procedure, is that they would like to see an example of Declaration of Conformity so that they can also check whether it is compliant with the requirements for a Declaration of Conformity. In essence, you have one unsigned, and when you're affixing the CE, you are signing your Declaration of Conformity.
Ferry: On the content of the Declaration of Conformity, there are certain requirements as well.
Martin: Yes, that is correct. They're also indicated in the legislation. Those are basically the formal requirements most essential to know and to keep in mind when drawing up a Declaration of Conformity. It needs to be clearly stated who is drawing up the Declaration of Conformity, on which product are we talking about, and also what legislation is applicable and has been met? Those are basically the most important things to think about when drawing up the Declaration of Conformity.
Ferry: Something that I noticed is that there's also a requirement, at least in the new regulation, to mention the UDI-DI number.
Martin: Yes, that is correct. That's a new feature for the medical device regulation. That is basically to encourage the traceability of medical devices, because it's a unique number for medical CE devices. Not unique as in serial number, because that's unique for every single device. The UDI number is basically identification for certain devices. It's already been in use in other parts of the world. For example, in the US, they are already working with UDI identifiers. Basically, what the UDI is, if we're talking about, let's say, the pacemaker, the pacemaker has a certain UDI that’s a unique device identifier. The pacemaker, let's say is shipped from the manufacturer to a hospital in a box that consists of five of these pacemakers, then the box itself has a different UDI number, and if you scan that UDI number, then you know that it regards a box of five pacemakers of that one manufacturer. It’s basically for traceability purposes.
Ferry: Which makes it easier as well to sell your product worldwide.
Martin: Yes, exactly.
Ferry: Then I’ve drafted my Declaration of Conformity, and then I as manufacturer, I need to sign it?
Martin: Yes. That’s an important thing because you need to sign it because otherwise it's just a document. When you sign it, then you declare that the product is in compliance with the indicated legislation.
Ferry: Then I need to put it in my technical file, or do I need to submit it to the notified body or to any other institution?
Martin: That depends. In essence, it's part of the technical file, and it's also your proof to the outside world that the product complies. If you're supplying your product to an end-user, to a hospital, then they will need to know that the product complies. With the Declaration of Conformity, they know to which legislation it exactly complies, so you always also send it together with your product. The next step is you do not need to basically supply to the notified body. If you need to register your product, then you also need to have to sign a Declaration of Conformity. The registration of medical devices is applicable to all medical devices. However, the procedure for the registration is different between the different classes, and I will just elaborate a bit more. For class I medical devices has its self- certification. You also need to register the product yourself, and then you need to register the product with the competent authority in the member state in which you are established as a manufacturer. Assuming that we are established in the Netherlands, that we need to contact a competent authority of the Netherlands, and we need to submit some information in a digital system actually where we indicate, "okay, we, company X, bring this device onto the market. This is some information about the device." Specific information that needs to be submitted is the Declaration of Conformity, and also some of the general information about the product. Then the competent authority will register the device, and you'll receive a confirmation of it a few weeks after that. In that way, your device is registered.
Ferry: Meaning, I've followed all the steps of the CE marking process, I have affixed the CE marking, I have drawn up my Declaration of Conformity, signed it, and then I'm ready to sell my medical device.
Martin: Yes, that's correct.
Ferry: Now I can sell it within the entire European Union.
Martin: Yes, that is correct.
Ferry: Worldwide as well?
Martin: No, not worldwide. The CE mark is the Conformity Mark for the European Union. If you're willing to sell the product outside of the European Union, you need to check with specific pieces of legislation of the countries that you would like to bring your product onto the market outside of the EU.
Can you sell your medical device in the UK?
Ferry: Let's say I want to sell it right now, so May 2020. I want to sell it to the United Kingdom.
Martin: That is possible because at the moment, we're all aware, of course, of the Brexit situation. The Brexit has a certain deadline until the end of this year. Basically, what that means is that at this moment, UK is still seen as part of the EU, and if you would like to sell your product in the UK, then you can do so when your product complies with the CE mark until the end of this year.
Ferry: After that?
Martin: After that, the UK is seen as a territory or a country outside of the EU. Then we're talking about if you would like to sell the product onto the UK market, they need to comply with the UK requirements.
Ferry: Is there a possibility, you think, that those requirements will remain the same? Or that, for example, in the case of Switzerland, there is a treaty between the European Union and Switzerland, so did you expect that something similar will happen with the UK?
Martin: I think so, and I think so because we talked about standards. There are a lot of standards, British standards, and they are saying things about, well, the conformity for the UK. If they would not accept any, let's say, CE devices, then they would need to create a whole different conformity assessment route, and that would take a lot of time and a lot of energy while they are having a specific route already laid out in front of them, which already has proven that it can generate safe products. I'm thinking that there will be a mutual recognition agreement between the EU and the UK. It might be that there are some specific requirements that will need to be followed up, let's say. I think in general, overall, when complying with the European requirements, you'll most likely also comply with the UK requirements.
Ferry: We've talked a lot about the CE marking process for medical devices. To summarise it, I distinguish six steps for CE marking a medical advice. We started with the classification of your medical device and identifying the applicable directives or regulations. In step two, we said we're going to determine the requirements on your specific medical device. In step three, we're determining the route to conformity or the route to the conformity assessment procedure, whether you need notified body testing or whether you can test it yourself. In step four, you're conducting the actual testing. Step five, you're compiling the technical file, and step six, you're affixing the CE mark and signing the Declaration of Conformity. This all sounds like a massive process. How long does it take to CE mark a medical device?
Martin: It's quite hard to say, and why is it quite hard to say? Because it entails a lot of steps as you just mentioned already. If we're taking into account that from step one to step six, it could take one to two months if you're talking about a real easy device and you have a lot of documentation already available, or you can produce the documentation nonstop.
Ferry: The easy device is a lot like a Band-Aid .
Martin: Yes. For example, if you're talking about the class one low-risk device, it could occur that not a lot of requirements are applicable, and that you can have a smaller file to be created. If we're talking about a more extensive and more risk medical device, then you're also dependent upon other parties. If you need to do some testing, it is possible that you cannot do the testing yourself. You need to have a testing laboratory. They will have a certain time. If you need some reports for a clinical evaluation report and you will outsource it to persons, it will cost some time. If you will outsource the instructions for use, let's say to a company, then it will take some time. You're dependent upon a lot of factors that will declare how much time is needed. Basically, from my experience, if you're taking in the entire process, you can count upon a year to gradually basically comply with the regulations.
Ferry: Meaning taking into account that the new medical device regulation will come into force next year, then it would be wise to start setting up your conformity assessment et cetera, your CE marking process right now.
Martin: Yes, definitely.
Ferry: Then talking about costs, can you say anything about the costs of certifying medical devices?
Martin: That’s also a very dangerous thing to say, I would always say. That's also dependent upon how much you will do yourself, and how much will you outsource. For example, w e can guide you through the entire process, but obviously we have a fee for that. Otherwise, you have notified bodies that have a certain fee, you have testing laboratories that have a certain fee. If you need to have some documentation drawn up by some medical experts or clinical experts, they will have some fee. It's really hard to say because there's not a specific price tag on receiving the CE mark, and that's basically because it's not a certification that you buy. It's a certification that you do.
Ferry: Right. Thanks for the explanation. It makes total sense to me. To wrap this up, because we've talked a lot already, how do you see the future of certification of medical devices?
Martin: Basically, things are getting more clearer but more stricter, and that's also something that you can see what I explained already about the medical device regulation, because that follows up the medical device directive, and some things are taking out and are more, more explained. Some things are more reviewed, and in essence, it will go all about safety. The legislation will need to change together with the technology. We need to ensure that all the products that we put onto the market remain safe. I would say that the legislation is already, let's say, on the train going somewhere and we're just passing through stations that will apply some more requirements or some more clarity about it.
Ferry: It becomes clearer for manufacturers.
Martin: Yes, it becomes clearer, but also more strict, and it seems a bit contradictory, but it's--
Ferry: It does.
Martin: That's the best way to indicate it. If it becomes clearer what the requirements are and how the product should be safe, then those requirements could be stricter, but the manufacturers do know what they're up against.
Ferry: Okay, thanks, Martin. Thank you so much for taking the time for this interview. It has been very interesting. I think it gives a clear insight on how to CE mark medical devices. This has been the longest podcast recording so far. Indicates the complexity of the topic as well, I think. Thanks again. We'll be in touch, and thanks for listening.
Martin: Thank you very much, Ferry. Thank you for having me, and good luck to all of the listeners, to ensure that the product complies and to keep going with that.
References mentioned in this episode