eSignature Legality for Product Quality in European Union

How to eSign a document: e-signature legality for Product quality in European Union

good afternoon everyone we're pleased to welcome you to the Washington labs Academy webinar series we hope you find the next hour so useful and informative we've developed our webinar series to deal with some of the technical and administrative issues that our customers face on a day to day basis we recognize engineering challenges can be complex and we're always looking for ways to support the technology industry before I begin I'm going to go over just a few housekeeping details first of all I hope everyone is able to see this title slide on their computer we have muted everyone's microphone to keep the meeting quality as high as possible a recording of the presentation is underway and will be sent to all attendees we can go through questions at the end of the presentation a full-screen view may be preferred your selection at your computer can be done using the menu panel in the menu on your screen go to view and then select full screen we estimate the main bulk of this presentation will take about an hour and we will allow some time to address your questions at the end and we do encourage questions during the presentation you may submit a question via the Q&A feature or by enabling the chat icon at the bottom of your screen and typing your question to the host and now I'd like to introduce our presenter Michael violet CEO Washington Laboratories Mike is a professional engineer and is founder in of Washington Laboratories he has worked in compliance since 600 megahertz seemed like a high frequency and has authored numerous articles and publications for and about the industry he has expanded wlls operation to Asia and co-founded American certification body with operations in u.s. European Union and Asia providing certification services to the global market so without further ado I'm going to go ahead and hand the presentation over to you Mike Thank You Christine I appreciate that introduction also everybody is attending today I started out in the MC over 35 years ago and I've been active ever since so I need to bring up the other presentation thank you well we started in this business in 1989 our first focus was on FCC mil standard 461 new emissions the susceptibility requirements we also participate with various organizations in the compliance industry our main services electromagnetic measurements products F product testing and certification for our United States and international markets some of the industries that we serve include the IT industry avionics wireless telecommunications products basically anything with buttons of wires and knobs is our customer basis but our presentation today will be about European requirements and the C e marking the C II marketing is a mark of conformity for European directives it was created the whole scheme was created to create a single market in the European Union currently there are 27 countries and about 300 or so million million persons are represented in those countries ambition there's a agreements within other than 90 countries that allow the C e marking to use for compliance assurance the real purpose of this whole scheme was to reduce what's called technical trade barriers to trade or TB T's by harmony and conformity assess arman izing conformity assessment processes this TB DBT term is a World Trade Organization term that is used quite widely around the world and in order to increase market access and reduce regulatory requirements for products being shipped around the globe so the c ii marketing process really broadly opened up the market access for a global manufacturing when we first started in the 80s it was pretty much impossible or very difficult for us to help clients put things on the European market large corporations could do it but smaller organizations and small medium mid-sized manufacturers did not have access to the European market when the CEO marketing was enacted this all changed and because we have a mutual recognition arrangement between the US and the EU this allowed our services and many other labs the United States to perform testing to the European requirements thus opening up big markets for our customers we serve that today one of the big questions involves what's going to happen to the UK under the brexit scheme nobody really knows and it's a hot topic of discussion I will say that the United States NIST a National Institute of Standards and Technology which is sort of our liaison with the US and between the US and Europeans into the conformity assessment business has indicated has created a MRA with Britain in case something the brexit does not go so smoothly anyway this slide shows a few terms and definitions we'll be talking about European directives the directors are legal documents adopted by the European Community Council of Ministers by law they must be adopted into each member nation national law by each member state now these directives don't call out technical standards but they refer to private standards making bodies to draw up these product standards the directives typically have what's called essential requirements and that what flows out of that is the various standards that are used to apply to a different the different products and these standards are called European norms or II ends and these are harmonized standards and common standards for determining conformity these standards are typically developed by consensus committees and a lot of them are based on existing international standards such as assists per se and Etsy standard again by law they must all be adopted in the national standards by each ec member Member State this is a type of harmonization is typically overseen by sun-sin elec which are the European Union standards organizations responsible for generating European norms ze by the way does not stand for Chinese export yet has it been joked before but Communist European which is French for European community another important term is that notified body a notified body is the organization that has been quote-unquote notified to the other countries by a national Authority which means that they have certain type of technical competence in the realm of which they're operating another term that is used broadly between the US and the EU is called a conformity assessment body or CA B or cab these are equivalent to a notified body for example in Washington Laboratories as a notified body an assigned number at 1388 and that process was we had to demonstrate to nist again that we were competent and we had the ability to make certain types of opinions and issue certificates for different directives this all is under the realm of the us-eu a mutual recognition arrangement that has been very successful in helping our clients access European markets now these are new approach directives over overruled or overwritten the earlier directives that we're a little bit cumbersome and difficult to use and the objective was to eliminate technical barriers as I mentioned before and create this common market these new approaches call out essential requirements where the technical details left to the committees and the standards so in the end conformity to the European norms demonstrates compliance and the products that meeting those essential requirements are eligible for C e marking around of 2008 the Europeans generated what's called the new legislative framework NLF the objective was to improve the internal market for goods and broaden the access it also strengthened the conditions for placing a wide range of products on the market and clarified many of the technical details and administrative details necessary to prove compliance in addition one of the games was to improve market surveillance and the quality of conformity assessments so really up the game in terms of making sure that products on the market did conform with the requirements and market surveillance is a pretty critical issue these days and typically what happens is each individual country in Europe has its own market surveillance program some being more robust than others honestly but typically the each member country has the authority to take products off the market and test them make sure that they comply with the regulations the new legislative framework also clarified the use of the seee marking and creates what's called a toolbox of measures for use and product legislation that's strengthening the conformity assessment process the following directives were renewed under the new legislative framework and you can see that these directors cover everything from toy safety to boats to explosives to measuring equipment and of course radio equipment low voltage equipment and EMC and these three critical directives are affected many many electronic products and the the year 2014 was quite a watershed year when the EMC radio equipment and the low voltage directive were reissued with the attendant numbers there there was a transition period but the transition period has since passed for all these directives and all products placed on the market from that transition place time forward must comply with the existing these directives there's some other common directives that apply to electronic products one is called the restriction on hazardous substances Directive the latest one so-called roast to which was issued in 2011 and its objective is to reduce the amount of heavy metals basically that are used in printed circuit boards and other electronic assemblies and the objective here is to limit the amount of leaching of these hazardous chemicals into groundwater when once they're disposed of or if they're disposed of in landfills a related directive of the waste electrical and electronic equipment directive or we directive was reissued in 2012 and it's a aim is to improve the collection treatment and recycling of electronics at the end of life again together these things these are trying to reduce the amount of electronic waste which is placed in landfill one interesting objective that's occurring now and I think everybody here can identify this is the striving to get a common mobile phone charger you know you have everything from the Apple format USB c2 to various other kind of plugs and I know I have a drawer full of chargers which are kind of useless and so the the drive is to create a common charger connector so there's less of these kinds of things just being thrown away with the issuance of the new legislative new legislative framework is some excellent guidance documents and guidance on the general C e marking is called the EU blue guide and the link is here and you can find this online pretty easily and it's a very useful document that has questions about all EU directives so it's a common it's a common document that applies to these directives and implementation of those directives and compliance strategies specific to electronics is the read guide and the EMC directive guide and the links there are there below and these documents basically supplement the directives by explaining some of the applications and interpretations of the various directive phrases and requirements so our world is all about what's called conformity assessment conformity assessment means you're taking a product and assessing it to the requirements to which it applies if you have a device that's going to Europe you have to apply the various directives well how do you perform that how do you prove compliance where you go through a process where you may do a a assessment and apply all relative harmonized standards published in what's called the Official Journal so going back to these harmonized standards the oj or official journal is the listing of the harmonized standards that may be applied to your device if you comply with those harmonized standards you can issue the C e marking without any further further examination the manufacturer prepares what's called technical documentation or TD that provides evidence of compliance and I'll talk a little bit more about that you must retain these these documents ten years after the date of the last manufacture of that device you're obligated by and the market surveillance authorities can ask for that documentation if there's a question of compliance after you go through that process the manufacturer prepares a do C or declaration of Conformity I'll have a little more details on that and then the C e marking may be placed on the equipment so the C e mark must be affixed to product packaging instructions for use or some kind of guarantee certificate it's on many many products now you can find it just about on every device that is sold globally it can be used with other marks such as safety marks and other marks and warnings as long it is not doesn't reduce the visibility and legibility of the mark so the flowchart here are the EMC directive basically starts with the emc assessment of the apparatus what you would do is you go to the official journal and see if the harmonized standards apply if you find the harmonized standards will apply you simply can check the compliance issue typically go to a laboratory or you can do the laboratory assessment yourself there's no specific requirements for laboratories you issue a test report assembly your technical documentation which really doesn't go anywhere you just have to hold on to it you may have a EU type examination by a notified body at that point that is always your option sometimes it's a requirement and I'll go through the right-hand part of the chart here so if you comply with all the harmonized standards you do an assessment you some of the technical documentation you issue a declaration of Conformity and you're off - off the market if your product does not conform with harmonized standards and you're obligated to go to a notified body which can assess the weather you are not you've met those essential requirements at that point they would issue what's called a type examination certificate and then you would keep us all this together again it doesn't go anywhere else it doesn't go to any regulatory authorities and then you're able to issue a c e marking now there are there is a database of notified body opinions or sorry notified body type examination certificates that is online and accessible to other notified bodies it's not a public website and it's basically there to lodge if there's ever been a if there's a rejection of your technical documentation and in a type examination certificate cannot be issued at the end you issue if you get the type examination certificate you still issued the declaration it could for me it's the same form and fit and function whether or not you're using a notified body or not again you keep all this with your technical documentation you issue the C e marking and off you go there are special provisions for fixed installations under the EMC directive what I've been talking about mostly are products that could go to a laboratory and can be assessed in the typical way however fixed installations which can range for anything from a power plant to rail to airport lighting systems to industrial systems do require compliance with the directive but there's no C e marking per se the directive mandates that you have to do some kind of EMC assessment which may include testing or may not include testing if there are EMC problems the authorities may be requests evidence of compliance so you need to do some either analysis or measurements for your fixed installation and if non-compliances are found appropriate measures may be required to limit the interference compliance with the radio equipment directive is similar to the emc directive now what the radio equipment directive did is that it basically included all the requirements for EMC in the low voltage directive under it's essential requirements which is under article 3 so you must do an assessment of the health and safety aspects of your radio product you need to do some EMC assessments and you may or may not go to a notified body again similar to EMC directive if there's no harmonized standard you're obligated to go to a notified body in order to issue a type examination certificate and the notified body would look at test reports your technical documentation your user's manual and critically what's pretty new and this whole conformity assessment regime is your risk assessment I'll talk a little bit more about that in a moment so if you fully apply to all your harmonized standards again you're off to the races you issue a declaration of conformity and you're done in our work at the Washington labs almost 90% of these projects that we do we are able to apply harmonized standards and the manufacturer can issue a declaration of conformity some cases there are no standards that exists for the device or manufacturers may choose to use a different standard and as long as the notified body agrees that you meet those essential requirements for the radio spectrum requirements and you can issue a type examination certificate the declaration the C e marking now we also have a interesting business in China and pretty active over there and many of our clients there which are mobile phone manufacturers Wireless product manufacturers accesspoint manufacturers apply harmonized standards but they're interested in getting a notified body opinion because it gives them either a level of assurance to their customers that they they've had some official assessment or they use the note the notified body type exam certificate to enter other countries we often get emails from telecom regulatory authorities with the attachment of our type exam certificate and they ask is this real and we verify that the document is real and the particular manufacturer can enter that country so we've gotten inquiries from Sri Lanka from the Philippines from Vietnam many other countries that may not have a firm or a mature regulatory system for evaluating products so they rely on the C e marking often or even the FCC certification sometimes to enter that market so the technical documentation I mentioned it's a file of information kept by the manufacturer for their product you must keep it ten years as I said before and it applies to each unit on each new day so it's essentially ten years after the last unit is placed on the market you need to show it to market surveillance if it's requested and you would supply it to a notified body if you're looking it for a type exam certification the technical documentation is composed of following items identification of the product obviously general description its operating modes its purpose its its use a conceptual design and manufacturing drawings if harmonized standards have been applied or not if they haven't been applied you have to in part err or not completely applied and you need to have a description of the steps taken to meet the essential requirements so for example you have a new technology that perhaps the standards haven't kept up with well you may choose to use similar types of testing for example or assessments and you would have to make the argument that you're complying with the essential requirements by using that adopted standard we're non harmonized standard so ultimately testing is involved so in general why do we perform emc your radio tests well during development make sure it works make sure it will pass the tests at production for regulatory approval so here at the lab we are usually have very mature prototypes that may be ready for release or final release so typically that's when we do the measurements on the device something that's ready for release often is the case however products may not meet the requirements so they have to either do some design changes or modifications to the product if that occurs we need to make note of that and keep that as on record in the test report you'd also do testing if there's any changes made to the product many times we get questions hey I've made this change what should I do well you have to look at what parameters might be affected is the RF output effective is the electrical leakage potentially effective have you changed the power circuit what what kinds of compromises might be to the product compliance and then you may do some gap testing to make sure that something that the device still complies you also may need to test do testing if any there any changes to the requirements so many times there are new technologies coming out there are new standards get applied and a new standard may be applicable that wasn't applicable before and this is truly in the case of the radio equipment directive and I'll talk a little bit more about that you may also do testing production line testing they may not we have some of our clients do regular spot checks some people some of the clients release a product and it doesn't go through any design changes so they don't have to do any more testing so for EMC and radio testing we're making measurements of the device typically talking about noise which is emanations from the device that may cause interference to other products other services immunity this is a measure of the products capability to withstand its environment could include radio frequency environment a lightning surge environment other users in the spectrum and we also have made you transmitter and receiver performance or radio spectrum measurements and what's interesting in the radio equipment directive that was not in the previous RT te directive is receiver performance and the aim of the radio equipment directive spectrum requirements is I would call it spectrum efficiency or spectrum use and so we want to because of the proliferation of wireless devices there's radio spectrum is more and more crowded the frequencies are that are being allocated for more services as expanding and so it's really paramount to make sure that the product stays in its intended band and doesn't cause interference of other bands the wrinkle on the radio equipment directive is that put requirements for receivers previously there was no requirements except maybe spurious emissions from a receiver now there's a co-channel interference and blocking receiver desensitizing tests that make sure that the receivers of a high quality and this again is about spectrum efficiency and keeping interference down safety testing is required and typically you're assessing hazards that are either electrical mechanical chemical or thermal and under the European safety requirements again it's a new approach directive a so-called self certification oh that's kind of a misnomer and the evidence of conformity to all the essential requirements these requirements again are intended for market inspectors and we need to have documentation to support the use of the C e marking in the end the manufacturer does a fix the C e mark and even in the electrical in the safety realm there may be a notified body required for some products this might be essentially very hazardous products an example might be a chainsaw that could certainly harm somebody and a notified body opinion or assessment is typically required for those potentially hazardous products so the low voltage directive again recast in 2014 and now enforces been around since about 1973 and it's a products intended for the connection to main voltages up to a thousand volts AC above 50 and up to a thousand volts ac and generally employed for household products information technology office laboratory equipment communications vir it's a applied quite broadly to low voltage products and it's for products where hazards are primarily electrical and they and in nature so once you've gone through your testing regimen your assessment regimen you're okay you're gonna issue a declaration of Conformity so this is your manufacturers documents a piece of paper usually fits on one page it's got to be included with your shipment and typically included with the manual it would have the apparatus name and product name interesting the name and address of the manufacturer or is authorized representatives so you must have an authorised representative in the in the european union and this has a recent parallel in the United States where the FCC went to a suppliers declaration of Conformity or s doc for benign electromagnetic devices such as computers and peripherals and non radio products so under the s stock procedures a manufacturer can test at any laboratory doesn't have to be accredited which is an interesting twist from the past doc do see procedure and what the s doc did is a combined verification and the declaration of Conformity for devices under part 15 in part 18 the additional requirement that was employed was that the manufacturer must have a authorized representative in the United States and this authorized representative would be the point of contact in case there was an interference issue or question one of the statements back to europe one of the statements was the following phrase must be on the form of the following phrase must be on the do see the EU declaration conforming issues and their sole responsibility of the on the DSC is the identification of the apparatus so it could be traced this could include a picture I'd typical you don't see that but it could include a color image the statement that the object is in conformity it references the relevant harmonized standards and may have if applicable the notified body and the type examination number so I we typically issue the type examination number a unique number out of our system then this would appear on the declaration of Conformity there may be additional information there's a signature there's a person's name on it and you would have the place and date of issue so when you're doing conformance what do you have to think about well you got to think about those directives you have to think if you're gonna use harmonized standards if you can that's the easiest route and there are a lot of standards the three links here show the links to the harmonized standards that have been adopted by the European Union for EMC low voltage and the radio directive and part of this new legislative framework that I mentioned before is to harmonize the evaluation of devices and what has crept into these requirements of slowly but now as a pulley a fully employed is what's called a risk assessment so the risk assessment is required for several these directives and what does that mean well you have to look at your device how it's intended to be used how it could be used and what kind of risks you might have that would otherwise compromise your compliance with the essential requirements it could be a safety risk it could be a risk that perhaps some unwanted emissions might appear in band and other bands spurious emissions it's a little bit tricky frankly but there are guidances on how to perform this risk assessment so you really need to understand how your product is used in its intended use of unintended use because radio products are all over the place where more and more Wireless society I want to talk a little bit more specifically about the radio equipment directive here at Washington laboratories about half of our products have kind of radio function anymore and we have to evaluate the under the radio equipment directive so there are big changes from the earlier radio and telecommunications type of RT te directive and its approaches to compliance so products place in the EU if their radios I have to follow directive to twenty fourteen fifty three and this is superseded the older one and what it did when it came into force is it includes the application of the EMC directive and the application of the load voltage directive so there are three essential requirements health safety EMC and radio spectrum so you have if you issue a declaration to the radio equipment directive you would not issue a declaration to the EMC or low voltage directive because they're they're incorporated by reference so what do you don't have harmonized standards we mentioned this before notified body independent body you can examine the technical file in cases where they have not fully applied radio standard and the outcome of this is a examination certificate and these notified bodies are typically companies they're not government regulated however they are overseen by the government regulatory authorities because the the relevant authorities have notified them to the rest of the Commissioner to the rest of the European community so again even if you are using a notified body to issue type examination you would issue a declaration of Conformity now one wrinkle one change in the read was that the notified body number used to be required if you used a notified body to issue what was previously called or was called the notified body opinion now you're not allowed to put the number on the C II marking and what this has done for many manufacturers it has allowed them to be a little bit more portable so we've had the case where we've had customers that have a notified body number on their labels on their C e marking labels just historically or as precedent so in order to have new devices they would typically return to the same notified body what this elimination of the number did is allows a little bit more portability and a little bit more more options for manufacturers because labeling is an issue for a lot of our clients because sometimes the size of the device is small or there's many other compliance marks that are required so anything that can save a little bit of real estate on the label is appreciated so under the declaration of Conformity approach you have to issue a do C in any case as I mentioned it's dynamic and it applies to each new product which leaves the production line this is a little bit different in the case of some certification regimens in the United States because if there's a change in the product or the standard or the state of the art the manufacturer has to make sure that the declaration conformity is kept up-to-date which means that the conformity assessment process may have to be re-examined so you don't get grandfathered so to speak the requirements change you must adopt the changes right away so if you have a product on the market already however it has it has already been placed in the customers hands or on the shelf you do not need to relive a lit however new units of existing models need to keep up with the conformity assessment requirements before they're placed on the market no such thing as seee certification and the seee marking process and the dlc process is a self declaration there's no certification it's always DLC even when a notified body issues a type examination certificate although there's a certificate the device is not certified this is different from the United States and Canadian regiments for example where you would go to a TCB or telecommunication certification body and you would get a certificate for that device a grant in this case for the US but that device is a certification process is a more formal process where for radio devices in the US and Canada you're obligated to go to a a TCB to get that certification so if you're a manufacturer outside the EU which I gather several of you here on the call might be the importer must take their illegal responsibility for the product so you must name this authorizes representative on the declaration but the importer takes obligation to make sure that it continues to comply the manufacturer is also responsible and the distributor is also responsible there's a term called economic operator and it's in the directives now that basically name everybody up the supply chain all the way back to the manufacturer as being responsible for continued compliance of the device so the Reds radio equipment directive scope applies to all radio equipment used for radio communication or radio determination which is a fancy name for radars anything that uses radio waves to sense or to image devices or communicate so this applies to transmitters receivers and transceivers does not apply to wired telecommunications equipment such as fax similes telephones that kind of thing unless it also includes a radio so the radio equipment directive is a high-level directive once you put something in there that transmits or receives a signal it becomes a radio piece of radio equipment and up to 3,000 gigahertz or 3 terahertz and we're starting to see devices that are creeping certainly into the dozens of gigahertz up to 100 gigahertz and we recently did some work on something that used 276 gigahertz as an imaging source for for imaging through paper and envelopes to see if there's any hazardous or they're deadly agents that may be passed through the mail so it's quite a fascinating use of some high frequencies we're seeing more and more action in the millimeter wave and this is being driven a lot by a 5g so the 5g spectra is up in the tens of gigahertz in a rate the read assessment covers as I mentioned before safety EMC performance and radio performance including receiver receiver performance so other directives may apply the read applies to anything with a radio it's and the EMC and lvd do not apply because it's already incorporated into the re D other directors may apply however you may have to comply with if you have a medical device with the medical device directive or if you have a machine you have to comply with the machinery directive and of course all devices must comply with the restriction on hazardous substances in the end once you do all this evaluation depending on your product and this directives you your declaration of conformity with state compliance to all the applicable directives now and under the market surveillance regimen the surveillance approach is coordinated by so called the ad Co in Europe however market surveillance is by each member state some countries as I mentioned before are a little more proactive some are just driven by complaints if they find a non-administrative non-compliance they can always make the manufacturer pay for retesting in the end all EU surveillance groups are sharing information so a lot of this has really gotten a lot of more energy behind it because the competitive nature of the products and this the wide and devices that are placed on the market everyday and it's not limited to Europe there's a pretty robust market surveillance process in Japan I'm aware of in the United States under the TCB program the TCB's are obligated to sample test 5% of the devices that they certify so it's a post market surveillance activity that is required by the Federal Communications Commission and the TCB's are obligated to report non-compliances to the Commission and also are obligated to submit a yearly report on the devices that they have sampled and tested so we're pretty busy with that sometimes so if you're operating a radio device there re you frequency bands so the EU is not all one country there are harmonized bands and there's a lot of them and under the ERC report 25 the allocation tables are there so if you're looking to do some intended use in some part of the spectrum the first thing you do is to go and research the spectrum and make sure that it's a harmonized band or if it's not a harmonized band that is used at least in one country under the radio equipment directive one of the requirements is that the device must be able to operate at least in one country the Efus or European frequency information system is there at that website right there and this website allows you to type in certain frequency bands and what returns is where those bands are harmonized or where they're allowed I've used it on several occasions and it's not perfect but it's a great starting point if you're putting a radio product on the market a little bit more detail is in European recommendation 70 - zero three and it's a great guidance for what's called short range devices which are typically low-power things that are normally less than one watt so if you're using a harmonized band you can ship to any of the European Union countries are there other restrictions that you have to think about is indoor use only required and certain ultra-wideband devices and certain devices in the five gigahertz band are required to be only be used in indoors is there a license required well that's going to be a country-by-country case so our restrictions are placing into service so there's so-called class 1 and class 2 devices if they harmonize if the band is harmonized and you're putting it into use without any restrictions the device is a class 1 device if the band's not harmonized or there's some restriction then it's a class 2 device so this isn't doesn't really affect the testing at all but it's important for manufacturers to comply with the radio equipment directive anyway so read compliance is pretty simple so you do assessment or test it make sure it passes you label the C e marking you may need to use a notified body type examination you always create a declaration of conformity when all aspects comply again once you comply with all the directives you must maintain that technical documentation and monitor the standards and the regulatory regimes to make sure that things don't change or you may want may not want to do that but maybe you have a good relationship with your test laboratory or or other associates in Europe that monitor this process there is a conformity assessment organization ready equipment directive compliance Association red CA and that's a great source for information changing regulations in the radio regime and you can join up as a member i don't recall the fees but they're pretty nominal but it's a they've got an email reflector and other resources that keep help keep up with the regulations for you in summary the directives carry all the legal weight and the standards have the technical detail in the end the under European regimen the manufacturers all responsible for compliance and the labs may assist manufacturers but accreditation is not necessary you can do your own assessment and again notified bodies may be used so that concludes my presentation if anybody has any questions Kristina have to try to answer them thank you Mike yep I've got a few of them here first question is if I integrate several products with Cee marks from different manufacturers and creating new product is a considered valid to apply a see e mark based on those other C marks well they we used to say C II + C II does not equal C II and that's still the case so you have you have to do something so what does that mean well you might have to run some some emissions tests you may have to perform some immunity work it really depends on the configuration but in the end you have to show that you comply with the essential requirements so yeah we we all often have this question we have clients that come to us and and we may give them a range of full testing - partial testing if you've got test results from some other manufacturer that may be considered you could go to a notified body and get an opinion based on your technical documentation so it really kind of depends on the situation and that's it there's a variables in there that have to be assessed but in the end you have to do something okay this next question is in reference to the other common directives you were speaking on can you speak about the eco-design directive no yeah I wonder if it ties in with row row growth in some way I really am NOT not sure about that I guess is it and maybe it's an environmental directive all this says that I looked it up it says adopted in October of Oh the directive sets mandatory ecological requirements for energy use energy related products only you so probably like refrigerators and yes similar to Energy Star in the United States yeah I'll be honest with you we don't have any requests for that and perhaps we need to do a little research and maybe we'll have a new service ok well there you go so the next question can a new revision of a standard for an EU directive be used before it's harmonized for example published in the in the Official Journal sure I you have to go to a notified body though because if it's not harmonized you're obligated to go to a notified body maybe perfectly using them for pretty perfectly ok ok um let's see the next question new approach you directives require manufacturers address on each product ships in EU countries having been made that the manufacturers email address is sufficient I haven't seen anything particular about the email address but you have to have the name and address that is a that is a definitely a new requirement that I think it's a little bit onerous but you know maybe a website or something like that more appropriate ok and oh the the question that I had before about that eco design directive they the person was said that it's energy regulation for ite products that they're looking for conversation about yeah I apologize I that's just not in my in my forte right now I mean we we variously done energy start type you know evaluations for the United States but there's really been no demand that well I guess our official position is to be continued to be determined that's it ok next question when complying to read you not use a seee number or do you not have to so I believe this refers to a number a notified body number if that's the case then under a radio equipment directive you're not allowed to put the notified body number on your CD marking even if you've gotten a you know a review and a type exam certificate in the notify body interest okay I looks like we've gone through most of the questions I guess we can wait a minute here I'll take this moment to remind everybody that this presentation is is being recorded and will be sent out to everyone after it ends but if if we do conclude today and you don't get a chance to get your question answered you can always contact us via email happy to take your questions Kristina thank you for your excellent hosting job once again and thanks to the attendees for attending our webinar have a great day night evening well before we log off guess what we got two more how about that so the red that person says can can that be superseded by another directive if you put if you put a radio in your device you're obligated to comply with the red you may have other directives that are apply for example maybe you have a medical device and we've done evaluations on stent inflaters that have a Bluetooth function so the device had to comply with the radio equipment directive and it also had medical device directive requirements so in any case you put a radio in your device it's a red product all right so last question here can you explain the role of an economic operator the way I understand it it's basically anybody in the supply chain that brings the device to the user so it could be a distributor manufacturer certainly it could be anybody who has an influence on the product placement on the market that's my understanding with economic operator that's pretty broad okay well let me check the Q&A here to see if there's any other ones that have come in looks like we have quite a few that are coming to QA could you elaborate on the cases or examples where notified body is needed or not what that flowchart I guess is the reference in what case is there not a harmonized standard and what is an example of a harmonized standard or non hominoid standard and how do you determine whether or not it's harmonized okay so harmonized standards first it will start with en which means European norm okay so first you start there and then you look at the rest of the number and if it appears on the Official Journal of the European Union and it's harmonized if it's not in the Official Journal it's not harmonized so an example of non harmonized standard where we've done an evaluation is under radio equipment directive there's a it includes basically anything in the radio path so we've done a little bit of work with antenna manufacturers for for automobiles and there are no harmonized standards specifically for that application that use and so we're we're allowed as a notified body to take a look at that and we would get information on what kind of compliance the manufacturer may done and that this could be performance or making sure it hits the right specification and at that point we issue a type exam certificate for that for that product another example in general over the past we've taken it's a military standard testing as a example of presumption of conformity in case you have to do some analysis and say what testing has been done and perform a technical justification why device meets the essential requirements it all kind of flows back up to the director where you have to comply with the essential requirements and I think use something that knots knots harmonized you're obligated to use another fine body okay um let's see can see mark be labeled no all right it's anticipated that it may come but they haven't allowed the use of a new label yet this is uh kind of in contrast to FCC and Japan and others label on things that have displays smartwatches okay um let's see does see e mark eliminate the need for the all Rojas mark no Ross mark is under under the product directive for anything that's electronics so you're obligated to comply with their roast okay and then again about the CE mark is is the CE mark on packaging optional yes must be on the product it could be on the packaging label the product right okay um let's see should we list both machinery directive and I lead on the declaration of Conformity they book if they both apply sure I guess it's the in vitro diagnostic directive if you devices a machine and its IV can reach your device and you have to put a radio and I can only thing read dead was eliminate the need specifically to reference the EMC directive and low voltage directive because it's incorporated in the evaluation looks like at that one more question here do you do consulting for more detailed questions sure that's what gets us out of bed in the morning just drop me a line my emails there on the screen be happy to help you in any way we can okay well oh look there's another one well LBD and EMC V incorporate into ivvv I believe their standard standalone I honestly don't have any experience with IV DDD I'd have to research that but if your device must comply with I'm EDD and it has electromagnetic compatibility or electrical safety issues and both the EMC and led okay so what the Rojas directive also be required on a read declaration of Conformity you would you would put that on there yeah okay let's see I think I haven't seen any other questions flowing and I do believe I've answered all of them good questions I appreciate that stuff to clarify them some things absolutely okay so I think at this point we can go ahead and wrap it up Mike so thanks very much for you taking your time out today to answer questions it's my pleasure thanks for your hosting again everybody have a have a pleasant day okay thanks and on behalf of Washington labs Academy I want to thank everyone for their attendance as well I'm going to go ahead and in the event I hope everyone enjoys the rest of their day until next time well bye