Information for use plays an important role in the process of product compliance.
Making sure that your product and its documentation complies ensures that you are allowed to trade your product internationally, your liability decreases and legal pitfalls are avoided.
In this podcast, I am interviewing Jens-Uwe Heuer James, a renowned lawyer specialising in product liability and product safety.
Listen to the interview below and make sure to subscribe to the INSTRKTIV’S INSANE INSTRUCTIONS SHOW on your favourite podcasting platform. You can find the free transcript of this episode on my website as well.
If you have a topic or question you’d like me to cover, send me an email here.
SOME TOPICS WE COVERED:
- Do you need to translate your instructions?
- Can you place your manuals online?
- How come that companies like Apple do not provide paper manuals?
- Do market authorities check your user als on compliance?
- What does the future look like when it comes to compliance?
- How can technical writers prepare for the future when it comes to compliance?
- What is the role of the technical writer when it comes to compliance?
LINKS MENTIONED IN THIS EPISODE:
Read the Full Podcast Transcript Below:
Hi, there. Welcome to the show. In this podcast, we're going to talk about product compliance and the role of technical documentation. We will talk about European legislation, liability, and international differences, and we will discuss a case study of a company selling products internationally and what they need to think of in order to be compliant. Making sure that your product and its documentation complies ensures that you are allowed to trade your product internationally, your liability decreases and legal pitfalls are avoided.
Jens-Uwe Heuer-James is a lawyer based in Hannover, Germany. He's a partner of Luther Law firm, an international law firm specialized in providing advice on all legal and tax issues that are of relevance to businesses, investors and the public sector. Jens advises on all issues pertaining to commercial law. He specializes in drafting and negotiating complex contracts such as plant engineering agreements as well as claim management.
Another focus of his work is advising on product liability and product safety, particularly on special topics such as CE conformity evaluation and technical documentation. His clients are final manufacturers and suppliers from the engineering and electrical engineering sectors and the consumer goods sector.
When he speaks at conferences, rooms are always fully packed. Jens is a frequent author on blogs such as TC World and renowned Lexology. He has written several papers and books for tekom.
Ferry: Can you maybe explain to us as well how you did get involved in the world of CE marking and compliance?
Jens-Uwe Heuer-James: It all started years, years and years ago, precisely in 1996 when I started as a lawyer. Then during my first years as a lawyer, from the beginning I worked in product liability issues because one of the partners in our law firm was an American guy during that time, and he was very keen on product liability issues as you can imagine. I got a pretty good teacher.
I was even privileged in the sense that I got in touch with the different approaches of product liability in the US and in Europe more or less directly face to face. During that time, I learned a lot. I have to say the development of the chain is quite significant when we're talking about the relevance of product liability and product safety law. In particular product safety law was, during that time, let's say more than 20 years ago, a really exotic part of the public law and, honestly, no one was really interested in it. That has changed dramatically.
I can just report from my daily business work, in the first part of this year, we had around 20 cases of market surveillance authorities going to the companies and object against the product, saying these products are not CE compliant. The whole product safety law issue became extremely relevant for the companies. The pity-part of the story is that they are very often not prepared at all and have no idea about CE marking.
Ferry: Can you remind us, again, what is CE marking about? What are the basic principles or thoughts?
Jens: The basic principle is simple. It's saying companies, manufacturers are allowed to place products on the market, to bring in particular products into the EU market, because CE is linked to the EU. They're only allowed to do that if the products do comply with the essential requirements defined within the respective CE directives such as the low voltage directive, such as the machinery directive, such as the directive dealing with toys etcetera.
There is a bundle of different directives for some product groups, and you have to comply with those directives. The fascinating principle with that is that the European Commission does allow the companies to control compliance with the essential requirements on their own. They have to do conformity assessment for the products, and then they can bring it into the market after, of course, they put on the product or they mark the product with a CE mark and they have the declaration of conformity ready.
These are the basic requirements of CE marking. In practice, we find a lot of companies struggling with the conformity assessment, not doing it correctly, for example, they do not refer to the correct technical standards.
Amongst all these practical issues and difficulties, we have also to face the fact that the technical documentation, which is needed A) internally as a so-called technical file and B) externally as the user manual, is not handled with care. I would say a lot of companies are of the opinion that the technical information, the user information is not that important at all. Honestly, they have to learn, facing the market surveillance authorities, that this is an important issue.
Ferry: What are market authorities doing in order to tell companies that it is important?
Jens: They are not telling. They are just coming to the companies and say, "Hello, here we are. That is what we require." It's not like a dialogue. They have a lot of power indeed and they're entitled to more or less stop the distribution of a product. If it's found really worse, then they can even decide the non-compliance of the product is of such a quality that we have to initiate a product recall.
Then they have the power to place an order and to require the companies to do all like this. In practice, it's very often the case that the companies will then just follow the market surveillance authorities and then just do the product recall or whatever is required and no formal order is, in the end, placed.
The market surveillance authorities have a lot of power. We have even to observe, for example, in France, that they're extremely strict. We have been reported several cases dealing with France, where the market surveillance authorities went straightforward to product recall and insisted on doing a product recall even when it comes to the user information.
For example, if the user information is not published in the French language, then I can guarantee you a French market surveillance authority will not accept this at all and will insist on a product recall.
Ferry: That's very interesting. I want to talk later as well a bit more about the requirements on translating your instructions. As a little reminder, why are user instructions such an important part of CE marking?
Jens: The authors of the CE directives have noticed what is the truth for many, many years, since the '60s, since we are talking about product liability law in Germany or in Europe, because it was always an issue of the product liability to say, "We require proper instructions from the manufacturer for the product to avoid hazardous situations whilst using the product." This has been a proper legal theory for ages. Of course, the European Commission noticed this in, and of course, they also wrote with regards to the drafting of the CE directive.
Ferry: Does it have to do with reducing risks?
Jens: Absolutely, because the user manual or the user information is very important, let's say instrument, to reduce risks and in particular the warnings, or safety messages which you have within the manual, or which you have displayed on the product, play a huge role in reducing any risks by using the product.
Ferry V: I think, for example, in the ISO 12100 - a standard that is harmonized with the machinery directive - this process is standardized in order to reduce the risks of a product and machinery in this case, there are three ways to reduce risk: the first thing you can do is by improving the design of the machinery, the second thing that you can do is by providing protective measures, the third thing you can do is providing instructions for use. That's the role of user instructions in the risk-reducing process, would you say?
Jens: Yes, absolutely. This describes precisely the concept behind it. First, you have to do a proper design. If it is not possible to have a zero level of risk after the design process, then you have to take care of the risks still visible and remaining. These risks are then object of the safety messages and warnings.
Ferry: Right. Are you saying it is absolutely mandatory to translate your instructions?
Jens: Absolutely. During the past, we had a bit of discussion saying, "Okay, we are not machinery, but within the machinery directive it's clearly stated: 'You have to translate.'" A lot of companies said then, "Okay. This is not relevant for us because we are doing electronic products” but in the meantime, we have the new legislative framework with the new CE directives and within these directives, it's very clearly said, "You have to write information in a language the user is able to understand, and which is then defined by the member states." That means, in other words, this is the language of the member state, the official language of the member state, so there's no doubt that you have to translate.
Even if you're not looking into the CE directives or the product safety law, you will come to the same result because if you're considering the function of the user information to limit the risk, to avoid hazardous situations during the use of the product, then an absolute need is that the user does understand what you want to say and what you want to say in particular with regards to avoiding any risk.
If he cannot understand because he cannot just read the language in which you provide this kind of information, then the function to prevent a risk cannot be fulfilled at all. In other words, since ages, it's absolutely clear when it comes to product liability cases if any information is needed to avoid the risk situation or hazardous situation, then you have to translate the information.
Ferry: Makes total sense to me. How's that for the medium in which instructions are being provided? Is that regulated in the European Union?
Jens: Unfortunately, it's not really stated, I have to say since now. What we have so far is some strong indications saying you have to present it in a form the user is familiar with, and this is still the paper form. You will find such comments in the guidance documents, for example, for the machinery directive.
In addition, I can only report from my practice as a lawyer that the market surveillance authorities are 99% of the opinion that the information has to be presented physically in a paper form. This is the situation right now.
“I personally would not advise my clients just to present the information online.”
Ferry: Do you distinguish a difference between user instructions and safety instructions, or would you say both need to be provided in paper form?
Jens: I had several discussions that are dealing with that and dealing with the terms “User Information” or “Safety Information”. Of course, you can say safety information has to be presented in paper form. Honestly, I did not experience at all any practical case in which a technical writer was able to demonstrate to me, "Okay, this is only for the use, and this is only for the safety, the relevant information."
In practice, it's simply impossible to separate the safety information from the information for use. If you do this, for example, you would separate all the safety messages, which you have at the beginning, usually of a manual, first chapter of the manual, just to have this is not the paper worth on which it is printed because you will hardly be able to understand the safety messages without the background of the user information.
Ferry: Yes, there's no context, you mean?
Jens: Correct. The context is missing, the link is missing, and then it's not usable at all.
Ferry: Then you get this questions, for example, what do we need to do with the intended use because that's clearly not a safety instruction, but it's essential in order to know where you use the product for, or even technical data, for example, the power supply of a product to a 230 volts, that's clearly not a safety instruction, but it's essential information in order to use a product safely.
Jens: Yes, absolutely.
Ferry: Interesting. I took notice of the new 82079 standards for user instructions, which is an IEC/IEEE Standard, published I think officially last May 2019. There is a slight breakthrough in that standard, I think, because that standard for the first time in the world of standardization, is mentioning that, for instructions for use, the medium that you choose, depends on the needs of your target group.
Does this mean when the standard will become part of the European harmonization framework that, if this becomes European law, it is allowed for companies to provide the instruction solely online as soon as they can prove that their users need an online manual?
Jens: First of all, I totally agree with your observation. This is really a significant step forward. Trust me, I was a bit involved, as some of our guys from tekom Germany were extremely, deeply involved in drafting this new standard. It was a lot of work to have it like this, but from the legal perspective, I have to say it's only just the technical standard since now.
I would say it is not like if you would publish this as a European standard then automatically all the CE directives have to be seen in the light of this standard. If not like this, first, you have to have modification of the wording of the CE directives or at least a clear statement by the European Commission or the working groups or the big directors saying, "Okay. We have seen the new standard and we totally agree with the observation it should be like this," but this has to be then also documented, for example, in the guidance documents, which I would not exclude that it will happen.
It's not like an automatic process, so I would say the companies should really take notice of this new standard and even from the approach with regards to user information in electronic form. Then as the next step as we are talking about technical compliance or product compliance, they should assess, is it possible for us under the applicable laws and regulations to take this new standard and to work on user information in electronic form?
Sometimes this is possible for some cases outside the EU, and then to observe the progress of the CE marking. As I said, a lot of things are happening right now, not only Brexit, we are talking about the new machinery directive, we are talking about as well a new low voltage directive.
I would say in the future, I'm talking about a time-frame of five, six years, we will have for sure a definite statement within the directives dealing with user information in electronic form. I really hope that we will succeed as tekom Europe to refer to the new standard, either within the wording of the directive or within the guidance documents.
Ferry: Right. It sounds to me like,... the landscape of standardization of directives, technology as well - the state of technology - is changing a lot, so it is a grey area as you mentioned earlier, but in the end, it's always how the law is being interpreted by means of case laws, for example?
Jens: That really depends because on one end, we have the case law but what is more important, for the market surveillance, is then the position of the working groups. The working groups do consist of representatives of the market surveillance authorities from all of Europe and representatives of all the industry associations.
Their task is to talk about the practical approach, the application of the CE directives in practice. Within this process, their task is to define more or less rules, how applications all be done by, on one hand, the manufacturer, on the other hand, the market surveillance authorities.
Ferry: You were talking earlier about five inquiries you have at the moment about companies that are investigating to reduce the amount of paper they provide with a product?
Jens: Right. Yes.
Ferry: Can you be a bit more specific about these inquiries?
Jens: Yes, I can. I can. It usually starts with a question, how we can reduce the paper or the amount of paper because we do not want to print 400 pages anymore.
Ferry: This question comes mostly from companies within consumer electronics?
Jens: No, honestly from different companies having consumer electronics, also foreign companies selling machinery, from any kind of business you can imagine more or less. It starts always with this question. Then it will usually turn out very soon that the quality of their technical documentation of their so-called manual is the problem. I think it's totally understandable when you are facing 400 pages to be printed, to be translated, this is pure horror.
But the question is very often, why is it 500 or 400 pages? What then comes out usually is that the company has not a proper understanding of technical writing in the sense that they are putting a lot of information within the so-called manual which has really nothing, zero to do with the practical application of the product, with the use of the product.
Very often, they have background information about the design of those products. This is nice for a guy, let's say, working in the design department of the company which uses this product but the operator is not interested in this information at all and it will be very often also in the position not to understand what is the background behind.
In other words, I see very often manuals, user information, which are not manuals and user information in the strict sense. This is just a lot of information floating around. So behind the question “we want to reduce the paper” it is very often the case that the companies have not a structured approach to do the technical writing, they are not familiar with the principles we have in our standards, e.g. 82079, and this causes them the problems. In the end, we have very often appropriate solutions, for example, that we take out a lot of information from the manual just to put it in information provided on the web page saying, "Okay, we give some background. We give some instructions for the planning of a project, what you can do with our products, et cetera, et cetera."
To have that, for example, out of the manual and then the manual will be significantly reduced and then we are not talking about printing of 500 pages then usually we are talking about 80 pages which will be printed then. Then surprisingly, it's not really a discussion at all.
Ferry: Yes. Clearly, Jens. Another question that comes up, you indicated previously that in general, based on your experience most countries still require printed documentation, like in 99% of the cases, I think you said. Are you aware of any situations where products were rejected on the market?
Jens: Yes. For example, Turkey. Turkey is a very good example. If the user information does not accompany the product in written form as a printout, then we have seen several cases where the customs in Turkey simply rejects the product.
Ferry: Turkey, but the turkey is not part of the European Union.
Jens: Yes, but Turkey has adopted the machinery directive, for example, more or less directly. We have also seen a lot of cases in which products are picked up by customs at the EU border, for example Hamburg Harbor or even Rotterdam, the customs are meanwhile keen on looking for some product safety aspects of the product.
In particular, is the product accompanied by a user manual, user introductions? And is the marking, the labeling of the product correct, because you have to indicate the manufacturer and importer by postal address. If this is not done properly, then the custom officers will not allow you to proceed further on with the custom to bring the product in the EU.
Ferry V: For example, you're mentioning the postal address. I think that's a requirement that can be found in most of the CE directives, for example, the EMC directive, the low voltage directive, et cetera, et cetera, as is a description of the intended use. I think most directives require that as well. Then there are loads of other requirements in other directives.
For example, I know the radio equipment directive requires to mention the bandwidth and the frequency of radio equipment. The machinery directive in Section 1.7.4, I think, they have a list of maybe 20, 30 other content requirements on the instructions. Are the instructions checked on this content? Do they really look if the instructions comply with those requirements?
Jens: The market surveillance authorities do that, yes. The way they handle such cases is then that they give products to an expert. This expert then will analyze, "Okay, are all these requirements fulfilled?" In Germany, for example, we have the Bundesnetzagentur which is the competent authority to check the RED directive requirements.
I had, during the last few years, several occasions, in which I was asked to talk to the guys from the Bundesnetzagentur and these fellows are really experts when it comes to the RED requirements. They know very well, what is in the directive and what they can require from the manufacturer.
Ferry: In this case, they're checking the contents of the directive. Have you seen that market authorities ask this other institute to check the contents of the instructions based on the 82079 standard, which is a European harmonized standard at this moment, at least the 2012 version?
Jens: Not exclusively. What I had as a case once was that the market surveillance authorities themselves have said, "Okay, this is the standard. We have to look at whether the requirements of the standards are fulfilled." I would say right now that the checking of user manuals, technical documentation against this standard is not something that you will have. In any case, it's honestly rarely done so far, but this is only a question of the next two, three years, then this situation will change.
Ferry: Now let's say that I'm a manufacturer of consumer goods. I sell my products in 24, 25 countries, so what I'm doing at the moment is I translate my instructions into all of those languages. They're all within the European Union. I’m into consumer goods, let's say like a remote control, a universal remote control, so I have a really thick manual in all those languages for a relatively small product, so it's a lot of paper.
As I said, I'm a smart company and I want to reduce the amount of paper, but I'm aware of the legal requirements on user instructions so I think it's better to provide at least the safety instructions in paper form. I will decide to provide the user instructions in paper form, but still, I want to reduce paper.
Would it be a solution for me to provide a quick start guide with the product which describes the basic steps to use a product together with the safety instructions, and provide all other information, which is absolutely non-safety related for example when there is an interface with a product on the television so all those print screens and how the interface works, I want to provide that online. Would that be a solution that is acceptable?
Jens: I'm struggling always a bit about these quick guides. Because if you're going back to the terminology of the directive, then no such quick guide is mentioned. I usually advise the companies to do it differently, just to say, "Okay, what I have in my understanding as a quick guide is the user manual, full stop, end of story, because this is what the user needs. Not more, not less.”
Then, to have a different term for the information which is then available online, for example, to say, "Okay, this is some sort of background information. This is some sort of add-on information," whatever term you may use. Because then if I look from the market surveillance perspective, then it's quite clear, you have a manual, no one can contest this finding, and you have reduced the paper.
Ferry: Makes sense. That sounds like a good way of solving this issue. What I'm thinking of now is that in the definition in the 82O79 standards, information for use is described as all information necessary to use a product safely, efficiently and effectively. There might be some discussion that all the add-on information that you place online is information that you need to have access to in order to use the product effectively, for example, but it doesn't harm your liability, I think, does it?
Jens: No, it does not. There will be some discussion about that for sure. I would clearly say the companies have to be well prepared because the standards and discussion mean the concept behind that they can explain, "Okay, this is useful information, but you don't need it for the use. It's nice to have, but you can operate the product on the safe level anyway with our so-called quick guide” as we discussed right now, more in the understanding of this is our user manual.
Ferry: Thanks. What would be the steps in order to create compliant user instructions?
Jens: I think the first and very important approach is to get a sort of setting. You're talking about a company. I think the first very important step should be that the company is aware about its product. This sounds a bit funny but what I experienced very often is that they have a catalog of 2000 products and they have no clue and no idea for which type of product is which legal framework applicable.
If you talk about product compliance, you first have to sort your products, saying, "Okay, this is my A, this is my product B, and this is C." Okay, now the next step, find out which legal framework has to be observed. This depends then on the area in which the product will be distributed because what I would clearly like to mention is the minute your product will pass the border, the minute--
Ferry: Sorry to interrupt you, Jens. Actually, you're saying there never is one general solution. It always starts with the current situation: who is the company, what is the product?
Jens: Absolutely. You're right.
Ferry: Make sense.
Jens: First you clarify, "Okay, this is my legal framework." Then next, of course, to find out, "Okay, these are the requirements. I want to distribute the product, for example, in the US, and in Europe, okay." Then the very good question is, "Do I need a different kind of manual or can I use the manual in Europe as well as in the US for some products?" This is very much doable.
If you observe and take notice of the real application of the product in the US means, who will use the product? For example, for an industrial product, the knowledge of the operators is very low. This has all to be taken into consideration. Then, finally, you can have or you should have a more detailed look on the specific requirements for the technical documentation.
As you mentioned earlier, there are some directives requiring really specific information to be presented by their user manual. When this all has been managed, has been put together-- We put together some sort of framework for our compliance framework.
What I advise is usually that this should be put then in a sort of database available for anyone in the company, that you have some sort of control about this framework and no one can say within the company, "I did not know." Because this is something which is monitored and no one outside the company would understand such matters.
Ferry: Yes, it makes total sense. How can the technical writer contribute to product compliance in general to this process?
Jens: Let me say it in a negative and in a positive way. Negatively, I would say the technical writer is not the person who should be responsible for product compliance, like a product compliance officer. This is not what the technical writer should do because I would be afraid that there is a lot of technical background that is missing.
This would not be good because also the education of the technical writer is not focused on the issue of technical compliance. Positively, I would say the technical writer is very well-trained usually and very good at doing research. How can he contribute to the product compliance? The technical writer can be the responsible person to do the research of all of the technical standards.
At least, he knows where to look on the internet or who to ask, or maybe do some research on the technical summits. This can be a super good job for a technical writer and here in this sort of job that you can put all his experience in. I think this should be the role of a technical writer when it comes to product compliance.
Ferry: Still, I think a technical writer within a company has to research and manage standards for an organization sometimes, or at least know which standards to apply for the user instructions or a safety expert, a compliance expert in the company has to do that. Especially in midsize companies there, they don't have the means for a separate position exclusively for managing standards. In those cases, what would be your advice for these companies?
Jens: For these companies, it's to decide whether they want to do it in-house, or whether they want to use a service provider. Many times there are a lot of service providers doing these jobs. It's simply the question, how many technical standards do we have to observe? How many markets are interesting for us? If it's too much, because this can be really a lot of work, then to decide, "Okay, this is too much to do it in-house. Just use a service provider. This would cost me money, of course.” But I think this is a good investment and the position of the role of the technical writer. I think you can give advice to them, to the management, saying "Okay, look. This is too complicated, this goes beyond my competence and this will consume more or less the whole of my working budget." I would advise them to go to a service provider.
Ferry: Okay. Thanks. I think we have to come to a closing. I do have a few questions left here that came in from a listener. First question, what is the most interesting case you're working on at the moment?
Jens: [laughs] Yes. You know as a lawyer, I cannot talk about my cases.
Ferry: You can be descriptive.
Jens: Yes, exactly. I have to find some abstract wording to describe it.
Ferry: Just say I'm working for this German car manufacturer in Wolfsburg.
Jens: (laughs). Yes. No comment on this. Yesterday, I had a very interesting discussion with a client. We were talking about the air industry. We are talking about airplanes and about putting fuel into aeroplanes. There is a technical solution for this but it came out during the last two years that this technical solution is not optimal.
A lot of companies working in this industry are still applying it. Now the surveillance authorities, as well as the standardization organizations, have decided we have to stop this. They have several deadlines and the very good question is how all our clients, which is a manufacturer perception and equipment, shall handle this.
Is it allowed to build and manufacture and sell on to this day, or does this date means no, the use of the equipment has to stop. The second question is also, am I liable as a manufacturer for my clients, if the clients which they have already said will not comply with these requirements. This is the setting of this case and we are talking about a very small, medium-sized company.
Of course, if you're talking about the aviation business, air business, then you're talking about something and about significant liability that may appear. It's also a case in which you haven't mentioned, if you continue to use this may also cause some problems with the airplane, which happened in the past, the Boeing 2.0.
Ferry: Right. Yes. Big industry. Big, big responsibilities. Big liability. Very interesting case. Thank you. The last question is a bit more philosophical. What does the future look like when it comes to compliance, do you think?
Jens: I think product compliance does play and will play a more and more a very, very important role for the manufacturers. They cannot ignore what they have done in the past. They cannot ignore the rules and regulations lying all over the world. This is also very cost-intensive.
The companies have to find ways to handle all the different regulations. I'm pretty sure that we will not have in five years a situation of the last rules and regulations. What we will have in five years is more and more, more rules and regulations that will become more and more difficult with the companies, to have the overview about this situation.
Ferry: Will it become easier to sell, for example, European products on the American market? Will there be harmonization between big markets?
Jens: This was always the political approach to out-of-fleet routing, selling of products all over the world. Honestly, I doubt that. I do see more dependency not to have a full harmonization because, very simple fact, for example the US can just make a whole lot more money by just staying for example on the other standard. There is a standard of doing all the, for example, all the text and labels, et cetera. There is a business concept behind all the different standards and no one really likes to give up this business. Certification is also to be mentioned within this context. I doubt that and we will not have full harmonization.
Ferry: How can technical writers prepare for the future when it comes to compliance?
Jens: I think very important for technical writers is to be very close to the development.
Ferry: Development of the product or of the standards?
Jens: No. To the development of the standards, to be very keen on getting any information on the further development they can get, and to be really close with the development. Some of them are doing that already. As you've mentioned, also I think it's important for technical writers to be close with business and close with the product.
Always I point out that I still have discussions with some technical writers during which technical writers are saying, "Okay, I'm not allowed to touch the product." What sort of nonsense is that? Technical writer, you have to be more or less the first user of the product so to be absolutely clear and familiar about the use of the product.
Ferry: I have one very, very last question, Jens. Something that just popped up in my mind related to the discussion about online versus print publication. What I hear every now and then is companies want to reduce the amount of paper, they want to put everything, all their user instructions online because they say companies like Apple do that as well. They don't provide paper user manuals with their products. I think they are correct because I really think those big companies don't provide any user instructions at all with their products. How is that possible?
Jens: This is possible because we are talking about very intelligent products. I have to say software and some computers, smartphones as well, are a bit of a special issue because first, you have a super simple product. Even a lawyer can use a smartphone. The potential risk of using a smartphone is zero, nothing will happen. It will not explode.
Ferry: Sorry to interrupt you, but then, does the market authority know this? I would say like a market authority in, for example, Rotterdam or Hamburg, they just say, "Okay. No, it's a product, it needs a paper manual."
Jens: Yes. The answer from Apple will be "it does not need a manual at all because it's self-explaining."
Ferry: Yes, you're correct. It is self-explaining, but I would say, for example, there are still-- It does emit radio waves, there is some magnetic field around it maybe. You can't use it in hospitals, just to mention a few potential risks. Do you need to warn the user for those risks or are these risks so little that you can ignore them?
Jens: They are very, very little indeed. I think Apple or other manufacturers of that sort of electronic product and software will stress the argument that if they did also, in the directives to be fair, then you have to put a manual in, in so far as this manual is needed. The information is needed for the proper use of the product. They will stress this argument and they'll say, "Okay, this is not needed at all."
Ferry: Okay, clear. I think you're mentioning a really important thing now. You're saying, "Okay, there is an argument, so there will be a discussion." We didn't talk about that during this interview. What happens a lot, of course, is there are always different opinions on how to implement the directive. When there are different opinions, you start a discussion and you try to come to a solution. Nice last words I would say. Thank you very much for this interesting interview, Jens. I can talk for hours and hours with you about these topics.
Jens: Yes. I give the compliment back. It was a very, very nice topic.
Ferry: Thanks. I think it was incredibly useful as well for the listeners. I think you will help a lot of listeners to create better information for use. I wish you all the best, Jens, and hope to see you very soon.
Jens: Okay. Thank you so much. Bye-bye.
Ferry: I would like to thank the thousands of listeners that follow my show. I'd like you to listen to this show next week and all the weeks that will follow as well. What have you got to lose? You are on your way to great happier and safer users. I invite you to email me with your queries or just to say “Hi,” or maybe you want to be in the show so continue listening or write that email right now, or you won't be safe anymore. I'm only joking, of course.
Founder of INSTRKTIV and keen to help users become experts in the use of a product, and thus to contribute to a positive user experience. Eager to help organisations to reduce their product liability. Just loves cooking, travel, and music--especially electronic. You can also find him on:
Profile Page, Linkedin, Instagram and Twitter!
You may also be interested in
19 May 2023
Creating Compliant User Manuals
During this free webinar I am going to show you how to create a compliant user manual that helps you to avoid legal pitfalls for machinery, medical devices, electrical equipment, and other products by using our INSTRKTIV Framework....
15 February 2023
What are the main differences between the machinery directive and new regulation?
In 2023 the machinery directive will replace the machinery regulation. This infographic shows how this affects your user instructions....