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hi everyone welcome to a sense webinar today meet mark understanding the cg mark requirements so the start for a quick introduction my name is Travis Miller I'm the general counsel here descent compliance today I'll be talking to you about the ce mark which is the conformity europa' standard that gives you market access into the European Union but before we really dive into the meat potatoes here let's take a quick second just to introduce you to a scent for those of you that might be a little less familiar and give you a kind of a general gauge about what it is that we're going to talk about from an agenda standpoint so you can kind of see there is it you're most interested in so in terms of the agenda we're gonna be looking at the scope of the see mark then the blue guide which is one of the dominant areas and practices that allow you to kind of comply with these standards rules and regulations I will also be focusing on technical files how those are built what they mean why you got to have them tie that into declarations of conformity the types of communications that are necessary to communicate to customs or downstream users importers and other individuals that you interact with in your sales in the Europe sanctions and enforcement what happens if you make mistakes or you're found to have made issue or not to follow those standards and then we'll close it up with questions now questions are important if you have anything that you're interested in along the way feel free to use the little toggle box up on the top right-hand side of your screen there's a questions and answers and also a chat area there I'll make sure to get to as many questions as I can within our time frame but I won't be answering them until the close of the program all right on to a sin so innocent the company really strives to be a compliance partner offering a platform based software solution to a wide range of rules and regulations that are divided into different Suites now first we have what we call our ethical sourcing suite and that covers Conflict Minerals any human trafficking supplier code of conduct transparency initiatives UK modern slavery Act statements and rules that really kind of implicate what behaviors are going on in the supply chain that leading you being able to purchase those products now we also work quite significantly in the materials management space and this covers and looks at rules and regulations that affect the piece parts and the materials that go into products these are things like your Ross's your reach is prop 65 full material content disclosures a lot of what we'll be talking about today you'll also notice that we deal quite extensively with configurable surveys and declara ballista kind of a line specifically to what customers and clients have and for those of you that have been on the end of receiving these types of communications you can see how flexible they end up being that very much kind of aligned to those necessary onboarding or supplier classifications and annual certifications that are necessary um finally we do have what are called inspections and supplier information management systems so these are all about factory audits product and inspections internal audits safety taste testing reports and data and allow you to store an archive of all the necessary information that you need to undergo and survive those audits and that's going to be a big part that leads into these CE Marking standards how it is that we can help you demonstrate what you need to do how it is that you can do it and most importantly how you can put it into one unique system that allows you to have the declarations of conforming and all the evidentiary collateral on hand for your technical files in the event that you ever go through a custom screening or audit or some type of a customer survey or inquiry all right at that stage I'm going to go in transition right over into the see mark directive so for those of you that are a little bit unfamiliar the conformity European marking or standard and Cee relates to the C mandatory conformity for certain products sold in the European Economic Area now it happens to be found on products sold outside the European Economic Area that are manufactured in designed to be sold in the EEA so what that means is that it's a very universally well recognized mark and people are going to understand that it has some type of a legal compliance obligations associated with it now that see mark really is the manufacturers declaration that the product meets all necessary are the applicable european community directives that applied to it it consists of what's called the cg logo which is just a little siena knee and an often a four digit identification number of the notified body involved in the conformity assessment procedure and you get those when you work with a testing laboratory or house or somebody that does some of those types of assessments on your behalf and helps you align to harmonize standards which we'll get into here in just a moment now the ce mark itself states that the European customs that the product is meeting those product compliance standards and its fit or it can be submitted into European Economic Area for market access so it is actually a legal attestation that you're communicating to the European enforcement authorities all right so now here's the key points about the CE mark one is by fixing the CE mark to your products you as the manufacturer declaring that the product meets all legal requirements for CD marking and that it can be sold throughout the European Economic Area this also applies to products made in other countries there so hold into the EEA so the importer of record bears a fair number of those responsibilities if you're working with a distributor or some third party to bring the product to market now there's two key benefits with the CE mark even though it can be a lot of work and those are essentially these one the businesses know the product bearing the CE mark should be tradable in the European Economic Area without restriction meaning that once it gets into the EEA it can move freely throughout all the different countries associated in that block without having to go through continued screening and then secondarily consumers are to know that they enjoy that same level of health safety and environmental protection throughout the entire e EA and if they buy something that comes in from Slovakia that it's not going to be different than something that comes in from Germany or that comes in from Ireland or what have you now in terms of action items what is it that you're supposed to do well first and foremost it is the manufacturers responsibility to carry out what's called a conformity assessment and that means setting up the technical file issuing the EU declaration of conformity and fixing that see mark to the product if you look at the back here malice your computer or the screen that you're staring at right now it's probably got one of those on it because most major manufacturers have fixed this mark go through those processes now manufacturers that do so have to follow six steps to fix the C mark the first is to identify the applicable directives and harmonized standards that's a critical one that's gonna define what you have to do what your in scope of the second is to verify the product specific requirements so for my product what is it that I necessarily have to do to align to those directives or get myself in compliance with that and the associated harmonized standards third to identify whether an independent conformity assessment by a notified body is necessary and then to engage in those practices fourth test the product and check that it's in conformity fifth draw up and keep available the required technical documentation that can be made available to the regulatory authorities or the importers as necessary because they're gonna be ones that are charged with making sure that what you've produced and what you've given to them is in fact in conformance and then finally a fix that see mark and draw up the EU declaration of conformity which should be just really a short form cert that kind of outlines all the different requirements and all the different standards that have been met they get yourself to where you need to be to make that product sellable a CE Marking itself seems like a ton of work and really it is but remember it used to be a lot more work so really it is kind of a value proposition if you think about it you see before the C mark came into place and the single market rule started to take effect yaks demonstrate compliance with each and every single European countries product regime were you wanting to sell that product and there was a plethora labels that were affixed all over products I mean at this stage you probably would have pages of labels it just should have to go on the product or you'd actually have to probably affixing different labels to different products depending on where it was going which would have been mind-numbing maddening so with all this said the seeing mark started a trend toward minimizing that increasing number of labels and marks that had to be affixed to products and it also started to allow standards that allowed numerous certification bodies and standards to focus on just the key attributes that would get you to market so the answer to that simple question is essentially yeah it is a lot less work to manage one set of rules with the trade off of gaining access to all of Europe which for most folks actually is one of the biggest if not the biggest market for their products however there is a trade off and this is the important bit if you are in one of the product classes noted below and these are all the different standards and classes and products they actually have specific CE Marking directors apply to them the failure to comply with those rules and regulations can ban your product from all of Europe so it is an all-or-nothing proposition here and if you get caught or a product is deemed to be non-compliant by the customs authority is for some other enforcement authority downstream you can have a very extensive and a very expensive product recall on your heads so just a little more details I was very much a short form answer so product lawfully manufactured in a manufacturing and one member state is supposed to be able to in principle to move freely throughout the entire EEA and it's supposed to meet an equivalent level of protection and law however there is a nuance here and this is something that's important if there isn't a union harmonized piece of legislation a law that says across the entire EU it has to meet these requirements the Member States can actually pass and they're free to legislate on their territory subject to the treaty rules and free movement of goods that's articles 34 to 36 of the TF II you so that's where you can actually have slight deviations to standards that exist out there now I'm going to be talking very predominantly about the see mark today but to something I want to raise your awareness too before we dive into a little bit more detail and lastly if there are some type of standards like that bear in mind that barriers to free movement across Europe which result from these differences the national legislation can only be accepted if the national measures meet one of three these three requirements one they're necessary to satisfy mandatory requirements so these are the police powers as they're called health safety consumer protection environmental protection making sure people are safe two they serve a legitimate purpose which justifies overriding the principle of free movement of goods and free transfer and commerce which is stuff to do but it has to be something that it can't just be to restrict your ability to gain access so domestic folks get an advantage there has to be a purpose that overrides that free flow of goods and commerce and then third it can be justified with regard to the legitimate purpose and that they're proportional with the aims of the legislation so it's not something that's so heavy-handed it's just going to devastate the market the ability to have that product has to be something that has a legitimate purpose it's proportionate that's the important bit it doesn't go over and beyond it doesn't go too far that's why there's so much stakeholder engagement and you're up to being honest all right so let's just assume for a moment that you're in scope chances are pretty good because you're sitting on this webinar bear in mind that there are a host and there's a regimented series of compliance assessment documentation that you can draw from and if you look through it you'll see that there are a lot of short form pages I get you some websites if you're interested just feel free to reach out to the local rapper if we give you a call sometime later let us know and we'll help you find exactly the types of guidance documents that you might be interested in but you'll see these are all brochures that walk through the specific rules and directives what's applicable as a whole website it's very nice that kind of walks through the single market of standards and how all that applies but without question the number-one document that you can know about and understand is what's called the blue back so what is the blue guy for those of you they are not familiar with it it's an instructional document that outlines the effect of what's called the new legislative framework or the NLF on product regulations it really is the best if not one of the only documents that really goes through and gives you a real cohesive understand you implementation about what all these regulatory regimes are intended to do and how most importantly they all fit together um you see the whole concept behind the new legislative framework and the ce mark really was to allow you to build a fix one mark one standard the Joe's compliance across all of Europe and to do that they had to override and start to turn down a lot of different pieces of legislation hundreds of pieces of legislation and consolidate them just into those 20 to 30 that I showed you earlier and what's going to happen there is that's even going to get further and further infused as there's new changes or new approaches and start to happen the legislation which very well could happen to things like reach other rules and regulations that we're familiar with and as that happens they too will become see mark directives where the standards or requirements and all the processes will only expand and eventually probably most rules and regulations that govern product are really going to fit in scope of that see mark it's just going to be a long process it's going to take time to implement but it does have some advantages as we discussed all right so now I'm going to get pretty technical here so forgive me if it gets a little dry but she turned into the website so here we go first and foremost how do you use this document well the key attribute here is that the blue guide is a big complex document is hundreds of pages and outlines a whole series of different CE Marking objectives in a very holistic fashion now section one point two point three so bear that one in mine is really the base introduction it kind of aligns your expectations with the NLF and shows how it all functions together all these systems start to work sections one point and 1.4 really outlined the liability functions in the statute of limitations for all the products that are placed on the market well I would have known as basic directives so basic directives they apply to all products kind of across the board these are things that are going to deal with very general terms if there's a recall there's something that's deemed to be dangerous what has to be done how it applies what folks are supposed to do to protect her to pull that product back now pages 16 through 17 specifically getting to the scope of the guide and that gives you a pretty good view into what you should be doing and how to use the physical guide itself now the next big part is understanding when you become liable so the first key concept with Europe is that liability incurs the moment the product is placed on the market and the European Union and that's an important concept because you see they don't have jurisdiction or Europe doesn't have jurisdiction over the entire world and all of your manufacturing processes your factory is located in in the air China or the United States they don't have that type of jurisdictional scope so the reason why all these product regulations really started to come into place was a direct result of that lack of control it was designer it was intended to regulate companies and businesses at the first moment where it was possible and that's when you would cross the jurisdictional threshold or when your product would be intended to or would be placed on the market inside of Europe because that's the first time where there was actually power or the ability to regulate that was really the birth of an adman of all these rules and regulations that we currently enjoy now the product itself is considered to be placed on the market when it is made available for sale to somebody the first time on the union market so if that happens in say the Netherlands and then that product ends up getting repackaged or repurposed and moved into say Germany or Spain it is that point in the Netherlands when liability first starts to apply now once a product is made available on the market it must comply with Herbal Union harmonized legislation at that moment so the product could be in theory flowing through Europe moving into Asia and it's just crossing across Europe and liability would not necessarily apply but at that moment when it actually comes to market it's been placed on the market for those quotes that isn't liability applies and that's an important concept now in order to kind of navigate that it's important also to have documented evidence of what I call it or it is the chain of responsibility so flowing backwards right to the origin it's the manufacturer that bears the ultimate responsibility for conformity with the product to be applicable to Union harmonized legislation and if something happens down the stream they're the ones that are probably going to get called in at some point into court or into the Associated enforcement action what responsibilities also applies and will apply whether he design and manufacture the product himself or because the product is placed on the market under his name or trademark so just by outsourcing the manufacturing in the design doesn't necessarily alleviate you from responsibility your trademark your trade name will incur that responsibility on to you the manufacturer is also responsible for designing and manufacturing the product in accordance with legal requirements of the relevant legislation and for carrying out that conformity assessment so if you had to summarize that you would basically have this flow one carry out the applicable conformity assessment draw up the technical documents create the declaration of conformity include instructions and safety information with the product maintain LOC traceable records technical documents and safety information for ten years after a product is placed on the market now that applies unless it's specifically dean something different in the legislation but that's your default then you have to fix the Cee and the other conformity march to the product is applicable ensure procedures are in place to guarantee continued conformity and certify relevant products and quality systems are in place to maintain and prove that you actually have conformance so those are a brief summary of what your requirements are you can I'm in Section 3.1 of the blue guy now corresponding to that there's liabilities for not meeting those requirements and the first is if you're not in conformance you're required to one take the necessary actions to bring the product into conformance and two to withdraw or recall that product as appropriate now what you're seeing up here is the business application gpsd business application site and what this is intended to do is to give you an electronic format to allow you to notify the Associated bodies to let them know if you have something that's not in conformance if you find yourself in that particular scenario we're more than happy to offer you a linkage to this website but this then becomes very much a legal matter so it's something that you do need to be cautious aware you now secondarily if your product creates an environmental health or safety risk you're required to inform the competent national authorities and this is the area where you're making a self disclosure is what it's called I'm stating that there's a risk there's a danger associated with this product so we are alerting to you and we are telling you that this product is on the market and it exists so we need to take action to correct that so the two different IRS there one is to fix it and then withdrawal or recall the product almost voluntarily and the second one is there's actually a danger here and because there's a danger I need to deal with call the self disclosure or notification to those bodies so two different areas two different standards the blue guide kind of walks through it and that's your site in the event that you find yourself in that unfortunate situation now section three point three goes to the next level the importers obligation because it's actually the important most of these instances if you're not the direct person yourself the manufacturer placing the product on the market it's your distributor it's your warehouse it's the individual taking that product ex-works from your shipping facility and then bringing it into the market that incurs that initial liability so they too have obligations associated to them the first is tune sure that the conformity assessment has been carried out and this is why if you engage in certain joint ventures or other types of engagements with a manufacturer or distributor or some type of a third party they might conduct an actual audit or an assessment of your procedures in your policies because they too aren't liable and it will be them as well who incurs that particular type of obligation you also have to ensure that the technical documents are available and at the C mark in the appropriate markings appear on the product they have to provide identifying information and the contact details for the imported product now that's important because this is the area where in the event that there is any type of a safety issue or any type of a recall individuals know who to contact and they can reach back out to the manufacturer and they can say oh my goodness your widget 1 2 3 4 is causing all kinds of havoc you better come here and withdraw and get it all back off off the market that's not compliant number 4 they have to maintain the product in a safe nondamaging fashion while on their care I mean it's a do no harm principle if the manufacturer produced a very safe and a good quality product the importer has a responsibility to make sure that that stays in a good workman safe fashion and then they're not damaging on their care now they also have to keep and maintain declarations of conformity records for 10 years after import unless otherwise specified in legislation and that's a big thing because that means that the importer if you happen to be an importer you should be having a system where you're maintaining that file when that record for that period of time if not you might well find yourself and non conformance with the ce mark and if that product goes bad you would do one that would conserve the liability by not having those records next you have to provide records on demand to the competent national authorities and a big part of this is cooperation the important person bringing the product onto the market is the first resource the first contact that goes into the jurisdiction so the competent authorities have an expectation of cooperation and that can be a very sticky situation if you're found to be kind of withhold not cooperating and then lastly you have to keep records of parties whom have sold products for 10 years after the product was supplied so there's a 10 years on the product once it gets imported and there's an aligned 10 years for when that product was actually physically sold now the reason for that is of course for the recall in the event of that product is deemed to be dangerous or has to get withdrawn from the market because the manufacturer did not do their necessary conformity assessment procedures it's your job as the importer to be able to identify those folks who received that product and to be able to notify them through the best possible means available that that product is going to get recalled and that they need to be communicating back to either the manufacturer or the person being liable for taking that import back and then we also have distributors who are outlined in section 3.4 now they're kind of a special subset of the importer of record because you see distributors also have that responsibility and need to know what products must bear the CEO mark and maintain the appropriate records for the products at the time the product is placed on market they have to ensure the manufacturer and the importer contact details are on the product and then there's traceability for the data and they have to initiate corrective measures and cooperate with competent authorities so just kind of a more defined subset of the importer of record obligation which is a bit broader alright so those are the three principal parties we've kind of outlined with the see mark is now let's talk a little bit about what you actually have to do and this is the build-out of what's called the technical file or the information that should be to pack it it kind of flows along where they can kind of prove to somebody that's going to review your records that you've done the right things and that you've got all the evidence and the due diligence in place you can kind of have a defensible position so technical files all right so the first thing to remember is that technical files are your records technical files are a set of documents that describes a product and can prove that the product was designed according to the requirements of a quality management system for EU shipments the file should contain the information required to show that the product properly complies with the requirements of the CD directives that apply to it so how do you do that well there are core requirements of all technical files as a general guide you have to have at least these attributes if you don't it's going to kind of be deemed a deficient technical file these are series of things usually a checklist that your customs authority or broker might go through or if there's ever an investigation you can be darn sure that they're gonna look for all these items these are descriptions of the apparatus usually accomplished by block diagrams how it's been put together wiring in circuit diagrams general arrangement drawings list of standards they are applied that's very important your standards are very very instrumental in Europe and demonstrating compliance we see records of risk assessments and assessments to standards the descriptions of your control philosophy and logic how is it that you came to these conclusions what is it that you actually did data sheets for critical sub assemblies this could be raw sheets this could be wee sheets all kinds of different items parts list what goes into it how do you make it coffins of any markings and labels that have gone on to the product in case something gets rubbed off how is it that you asserted compliance copies of instructions user manuals maintenance installations what somebody should be doing to keep that product safe test reports quality control and commissioning procedures and declarations of conformity that you received from your suppliers or that you've actually physically made now looking at that as I've said harmonized standards are really the building blocks of a technical file now harmonized standards are very important in Europe because European standards to which regulation number 10 25/12 12 gave sectoral Union harmonized legislation a very special meeting you see a harmonized standard must be transposed at the national level by the National standardization body and that's important that means that across all of Europe once you have a harmonized standard every single country recognizes it as a way that you get yourself into conformance this transposition also means that the European standard question must be made available as a national standard in an identical way that's why it takes so long to do these things that each individual country has to get in their native language in their native tongue it has to have the same meeting so there's a huge amount of work that goes into these things and that all conflicting national standards have to be withdrawn in a given period that is equally important because once these harmonized standards come into effect anything that used to exist needs to go away it can't be competing standards that conflict with a harmonized standard and they won't be applicable which is equally important now a harmonized standard does not necessarily have to cover all essential requirements but it must always be clear which requirements are in scope and the reason for this is that those cited requirements those essential requirements of that cmart directive are given a presumption of conformity which from a legal perspective is great it means that because you did this everybody is going to presume that you're in conformance so the workflow to do that kind of follows this pathway if you need a visual so the first you look at all the essential requirements legally binding by that piece of legislation check the creek tick tick tick tick tick check once you do that you can conduct a risk assessment or an equivalent that should be done by the manufacturer to say we meet these requirements and then you can look at those identified standards the applicable essential requirements that apply to you the manufacturer of the product so you see how someone get filtered out those are the ones that kind of continue on now at that stage there's two ways that you can kind of assess compliance when you make your declaration or your cert the first is to use that harmonized standard and by so doing you achieve that presumption of conformity so if anybody audits they review it goes to customs and they see that you said these are the three different standards that apply to us and two of them have gone through a harmonized standard review they're gonna say okay we assume that those are okay but the other one's going to be this third statement here in an ED instance if it hasn't gone through it doesn't have a and I say that applies to it there is no presumption of conformity I mean they're going to review your technical documentation and much more detail on that and they're going to look for gaps they're going to look for things that you haven't done they're going to look for areas of inconsistency with what they perceive to be the essential requirements and that's how an audit happens now in terms of that you also have this process flow which is known as the conformity assessment and this is essentially the steps you should be taking to diem if you are in conformance to that piece of legislation or the other legislative requirements I know it's a bit of an eye chart but I'll do the best I can this is bigger than I could make it to get it on the slide deck so the first thing you have to do there is you see the manufacturers drafting technical documents and the manufacturer takes all measures to ensure compliance to the products and legislative requirements at that stage that's when you can launch your design production processes and here's where conformity assessment starts at this stage you have a choice between two different legal provisions you can use a third party who's gonna check an audit go do your due diligence go collect those raw certs go collect those out there at test stations or you can compare out all those checks yourself the big area there is one liability resources and the amount of expertise that you have on staff to dedicate most of us don't have folks just sitting around waiting to do conformity assessments or go to supply chain do diligence or go to testing and analytics so we'll use third parties that's a perfectly acceptable mechanism one that's actually well-received typically in Europe that that says you have an assessment result are you in conformance are you not if you happen to be in conformance that's great it means you can draw up your declaration of conformity you can keep your records you can put everything in a nice file where it's all stored and then at that stage you can put that C mark on your product and the product is ready to be placed on the market now the alternative is what happens if that assessment says no you have not met the essential requirements well if that stage you gotta start all over and go right back over start to drop those technical documents again and go through that same conforming assurance procedure until you get back to the point where you can say yes I have met all my requirements and this product is fit for sale on market in Europe now we've been building a technical file the key in the number one thing to remember is that it's all about traceability from a regulator's perspective I'll put my regulator hat on for a moment traceability matters because that's what enables effective enforcement through market surveillance and to implement corrective measures that could include withdrawals and recalls if I as the regulator receive a technical file or a document from say a distributor or an importer of record and I can't see who the manufacturer is very clearly and I can't see how you're going to track records for ten years and I can't see how you're gonna tell me who it is that's gonna be receiving that product or who's gonna sell it I really don't want that product on my market and the reason for it is because if something goes wrong with that there's no way that somebody's gonna be able to figure out who's responsible and where that product is gone where other folks could get hurt second Union harmonized legislation requires the traceability of products made available on the market without stipulating how to achieve or implement these requirements so in practice the regulatory authorities don't really care how you got there they care about this you should did it and you did it in a cohesive comprehensive fashion so if you choose to outsource to a third party if you choose to buy your own testing and laboratory equipment and do everything yourself if you choose to not do much but just make those attestations they're not going to care up until the issue happens and that's when real big penalties and what is it you chose to do is going to have a big dramatic effect but what that does mean also is that the database technology how you choose to archive all your files and records for that ten-year period is up to you but you will be measured by its effectiveness or lack thereof all right so that's that let's now try over into declarations of conformity so you've analyzed your done your conformity assessment you built out your technical files you finally pass muster you say goodness gracious this thing's ready to sell in the Europe finally now it comes the finished work product which is known as the declaration of Conformity now when you use the CE mark to declare you are essentially making a declaration of Conformity but bear in mind that not all products have to be CE marked some don't fall within the scope one of those rules or regulations so the obligation to fix the CEO mark in extends to all products within the scope of legislative acts provided for its affixing which are intended to be placed on the European Economic Area so you can find products in own embassy then just not in scope . but the CEO mark must be affixed to all newly manufactured products that are subject to legislation providing for CE Marking whether manufactured in Europe or outside of Europe it must be a fixed if you want to be used or have a secondhand product imported from a third country that's subject to the rules associated with CE Marking and they must be affixed if you want to have a modified product that as new or subject to legislation cover in the CV marking which has been modified in a way they could affect the safety or the compliance of the product with applicable harmonized legislation so if you're doing take bags you're changing products you're buying secondhand products off the market and you're fundamentally changing them and you're doing something to them and you can find yourself in scopus EE and having to put those requirements on there just something to be known for those of you in kind of repair or the modification business now when you're drawing up a declaration of Conformity and those are the terms it's the words that are used the manufacturer or the authorized representative so that's a third party that you appoint in Europe that has the ability to do that for Korea must draw up and sign an EU declaration of Conformity as part of the conformity assessment procedure so there's a physical letter there is a document that goes there has to be endorsed and that EU declaration of Conformity must contain the relevant information that identifies 1 the Union harmonized legislation it's issued against the manufacturer and the authorized representative and are notified body the product and provides a reference to harmonized standards or other technical specifications that are applicable now you are supposed to produce a single declaration of Conformity that's the requirement and the reason for that is the regulatory authorities don't want to have to master futz around with 5 or 10 or 15 different declarations of conformity for all different types of standards that's really supposed to be one cert that covers everything that says this products in conformance here you go now that single declaration of Conformity can be made up of a dossier containing all the relevant declarations of conformity so it can be a long form sir or it can also be this short form letter but at a minimum a model declaration of Conformity really should contain these ADA items and if you look at your own and doesn't have one of these and you probably need to make a change so the first is a number identifying the product or the family of products a lot set cetera something that's identified what is it that you're declaring against to the name and address of the manufacturer the authorized rep who do we contact in the event that there's a problem 3 a statement the declaration is issued under the responsibility of the manufacturer a knowing statement that yes I have done the conformity assessment procedure I am making this cert on behalf of this family of products and here's how you're contacting an event that there's been a fault or something has gone wrong for supplementary information for traceability anything that you can provide anything that goes in there that shows or evidence is your 10 year commitment how does it you've met that period what is introduced how does it you're perceiving traceability through your supply chain 5 citation to all the Union harmonized legislation that you're leveraging and using six the name and the identity of the notified body if applicable so who would that you're using to achieve conformance with that declaration who did your test who's your laboratory authority who it is it has that four digit number seven any supplemental information this is where I attestations other certs and the type of deficiency statements confited eight the date of issuance very important that's going to cite to the regulations are in force as of that date has to also be accompanied by the signatory of the authorized representative and the title of the endorser this is what i'm attesting to on this date because this is the rules that were infective of that date don't get that wrong and then who it is it's actually making that attestation and it's claiming that personal level of responsibility for it which is important because they will be contacted and dragged into the enforcement authorities in the event that there is an issue and it comes down to the final kind of activity of fixing that see mark so the ce mark may not be affixed until the conformity assessment procedure has been completed that's important you can't just have those labels running all stop you're supposed to do the conformity assessment first and that's to ensure that the product complies with all provisions of the relevant Union harmonized legislation now this will usually be at the very end of the production phase so everything's done we found there's no problems now that see mark can be on a data plate and it can be sitting in there with everything that you need so you can have that waiting but it can't be on the product until you're done so that's the key point if they find that then they'll find a non conformance or non you'll not be a conformers with the rules and regulations if that's to discover that that's your process now the CE Marking may not be affixed in any other stage in the production until the conform procedure is verified as part of the production phase so the question most people ask me is well where can I put my C mark you know this thing's big my product little you know I have lots of different pieces parts that go inside of my product or those I'll have to have C marking well here's basically the summary that's outlined first the C mark must be affixed visibly legibly and indelible to the product or honored today to play that's the first one you gotta be able to see it can't be kind of tucked up or underneath something if it's a big rack and it can't put it underneath or bury it inside someplace people have to go see it when they walk up to it to the requirement of visibility means that the see mark must be easily accessible for all parties so if I'm something to handle in it if I'm physically gonna come to contact for that product I want to be able to see the see mark must be affixed to the back or underside maybe a fix the back or underside of the product provided that something that's accessible and visible the requirement for visit visibility apologize does not necessarily mean that the cee marking must be visible before opening a product packaging because of fixing the see mark also to the packaging is only necessary in case it is explicitly required in the relevant union acts so that's one that gets asked a lot after me on the outside the box had to be on the packaging well the truth is only if it's in that legislation it says it must otherwise it can just be on the product and that's fine third there has to be a minimum height of five millimeters to ensure that it's legible however according to multiple pieces of legislation the minimum dimension of the CG mark can be waived for very very small devices so you can get smaller in the event that this is the only way that you can get it on your product now regulation EC number 765 2008 decision 768 2008 see EC do not forbid any kind of design requirement so if you like the hollow view if you like it too you know I have certain dimensions like a full black one that's okay colors are even okay it just has to meet the above reference conditions and electronic labeling purely is not acceptable so you can't just have a barcode that's a C or something to that respect it actually has to have the physical letter C so there's your technicals so what does it end up looking like well here's an example data play a very good one you've got your CD you got your certified body you got your attachment year 2015 manufacturers contractor - how does it reach out to them european technical number DOP number product type identification very good day to play good example therefore you now also an important feature and I see these all the time removing competing marks so the Cee marking represents all mandatory conformity marking and it's supposed to all have the same meeting and that should mean that anything that existed before that harmonization effort took place needs to be scrubbed now fixing of additional marks say like a protected trademark manufacturers brand you know the private national marking that's fine because that's not going to something that competes with what it is that the CE mark means but it does mean that you've got to get rid of this kind of stuff now these Ross check marks leaves compliance no lads all those things those are competing marks the CE mark is already saying that your Ross compliant if you're in scope it's already making those at a stations so if it happens to be on there you're actually not conformance with the rules now they're not withdrawing a load of products for that but this is something get you hung up and you will get fines and dings and other areas associated with it and it's just a bad practice you know why are you wasting ink why you're wasting labels it's just not necessary any longer so this leads us on to kind of the last topic that we'll be covering today and thank you all for bearing with me um so we're reaching sanctions and enforcement so what is that well it's all about catching the bad actors member states have the obligation and this is there a rule that gets placed on them to ensure that the correct implementations of the regime govern CE Marking are in place and to take the appropriate action in the event of the improper use of the marque so this is their obligation the member states have to also provide for penalties for infringement which could include criminal sanctions against individuals the signatory physically on those declarations of conformity is usually a target there for serious infringement now member states must also notify the Commission and to the other member states when it decides to restrict the movement of a good due to an incorrect effects into the CV mark when it takes action against those who are responsible for non-compliant product marrying the C mark so if they're gonna hold our product withdrawal for something that you've done or for some type of a harm that's occurred or if there has been some type of an incident or an accident everybody else across the European Union all the other bodies are supposed to get notified and that's why these things can spiral so quickly into a really catastrophic product recall if every country across Europe all of a sudden gets alerted that you've done something non-compliant it can become a pretty big deal in hurry this is up to the Member States to lay down and implement the mechanism for enforcing the provisions of the regulations in their territories so according to article 41 of the regulation the penalties provided for shall be effective again proportionate so that's always kind of mitigating thing in Europe they try not to be so sledgehammer they try to use something as proportionate to the harm that you've done and dissuade so that's where it can ramp the other way so a proportionate means we don't want to hit you with a sledgehammer if all be done there's a minor infraction but dissuasive means that we want to get your attention we want to make it not want to do it again so those two kind of competing concepts and they may be increased if the relevant economic operator has previously committed a similar infringement so the worst thing that you can do in Europe is be a repeat offender and it's those incidents when the fines can escalate quite quickly or most typically that's when a criminal prosecution can occur for a serious infraction or something that's been deemed or been found to actually be malfeasance I'm purposely trying to evade the law and those are the instances where usually criminal activities begin ensue now sanctions apply and here's just a couple examples for you usually through specialty staff that investigate in-country violations so these are your investigators and these typically tend to happen when something really bad happen so here's an example here it comes up in the CE Marking enforcement kind of a write-up where you had a review done by the Switzerland that looked at about 37,000 600 items of equipment and 1,100 cases of those that were found to be CE Marking performance problems of the 3962 items that were subject to rigorous measures so these guys didn't probably have those harmonized standards so they get that stepped up level of enforcement so this kind of gives you a metric about 10% or so of the products at inter market and of those about 1/3 or found to have problems a high proportion were found to be defective so that's almost about 1/4 of those that were investigated and none of them met these are that that's the specific regulations they were looking at in particular relevance now you can see here that the ones that are deemed to have the most issue or the EMC tests that's electromagnetic compatibility meaning that it wasn't a line there kind of designed for European energy and compatibility standards 47% did not meet the machinery directive which is kind of a big one and that's when people can get harmed or hurt as you can see by this story right here we actually had an individual who was working on a piece of machinery that had been altered or it had been gained or modified and the CE Marking conformity assessment was not revaluated after that so I don't have happened is the modifying agent and the manufacturer both got called in as liability very sad story and then 89% had technical non-conformities so this is an important number so even though 33% and 47% actually had issues with the regulations 89% almost 90% of the issues that they identified or technical non-conforming meaning that you just didn't do the work to get your technical documentation in order and that's why it's so important to do that particular aspect because that is what triggers most of these types of audits and reviews that's what gets you in trouble 90% of the time so we're some in-country enforcement takeaways one is you know once a product is in the European Union it displays the see mark there's always going to be a presumption of conformity it means that you pass customs you've got it in there it can get an operation so as a result if you're going to look at the prosecution's and investigations that take place for an in-country enforcement that's almost always going to be a result of accidents or incidents something bad happens is there was all this product now an investigation that finds technical non conformance tis in a manufacturers technical file substantially more often than any other single violation meaning that it's that rushed movement just to get the technical file out not to do the conformity assessment procedure in full they get you in the most trouble and these technical file violations will create a presumption of violation they're going to subject you to those long form those much more rigorous evaluations if you have them so they're gonna take a very quick look if they don't see that you're technically capable then that's when much more detailed analysis happens that's when a lot more the enforcement or the stepped-up enforcement tends to happen so just an area to keep in mind there now the secondary area is actually getting that product into country into market and this is where customs usually kicks in at the national weights measurement offices and those types of guys and in these instances it's usually an import screening that occurs and what you'll see here is four different areas so here we got a toy directive violation here we got ourselves an electronic appliance violation we've got ourselves a protective equipment violation and here we got ourselves a LVD violation this is actually Ross apologized as well so each of these are different CE Marking conformity standards and you'll notice that each one of them can result in the exact same issue product withdrawal and recall from the market which is the most typical violation that you'll find a most typical measure that's ordered by the authorities so how is it that they come to this well it's usually applies to importers and non EU based manufacturers they have to contend with the customs authorities to try to enter into the European Union and this is what the dominance of enforcement actions actually didn't happen with see there's two ways customs authorities can inspect the product well the first is that they can do laboratory analysis they can take one of those products that can rigorously test it or the second is that they can do technical documentation inspection so think about that pragmatically one of those is going to cost money it's going to take several weeks and ones just a cursory documentation review from a spot check yeah you guessed it the vast majority of customs violations and product withdrawals are again a result of technical documentation gaps where people just didn't go through all the necessary conformity assessment procedures and they got pained and there are literally thousands and thousands of thousands of these things every year all right so with that said we've covered some significant ground we're just coming up to the top of the hour I did want to call your attention just do a couple quick webinars and conferences that are coming up in KC this is parked your interests are you just interested in hearing more about what a sense got to say and offer um one's gonna be Conflict Minerals coming up here in just the next couple days we're also looking at a couple educational summits they're available and finally we're gonna be touching off of the restricted substance and product compliance forum with our good partners over there at their testing analytics house tetra Tech big consultancy it's gonna be a really good good program hope you can make it and we see you in one of these programs all right with that said it looks like I got time for just a couple questions and this is always a topic that generates a lot of them so let me open up and try to answer a few before we get to the top of the hour doing my best to be respectful of your all time if we don't get to any of your questions I bear in mind that we will certainly get back here after the webinar and outreaching know we always like just to hear how we're doing as well all right first one what if your product is C e marked to show compliance to the original directive and now that Ross is included do we remove the CD market the product is not Ross compliant yes but bear in mind that there is a pretty significant consequence from that CE Marking is a mandatory mark to bring your product in Europe if you're in scope so just judging by the way that question was worded you in scope of Ross assuming that's the case if you remove the C mark and you're in scope or Ross your product can't go to market in Europe so an alternative way to think about that is a maybe you have to redesign or change the product to get it Ross compliant next question is there any solid evidence that directives like the machinery directive has actually reduced worker injury rates in the EU countries um there is to a degree more importantly is that its harmonization and you know that's the thing to always remember about the CE mark all these standards is you know there have to be ways that something can be made so it's consistent there have to be ways that you can produce something to show that it can be measured against because you know what gets measured gets managed it's the old adage and all manufacture and everything that we create so if you force people to measure or to look at certain things certain attributes then the reality is is that there's a way to enforce it there's a way to audit it there's a way to see if somebody is actually doing something and only because of the C mark and the new regulatory framework do we actually have one of these standards that we have to comply with you know for those of you that were around a long long ago and I date myself which is terrible there used to be a plethora of these standards and rules and regulations and it was literally a mess to bring anything into Europe you couldn't just bring something to here you had to bring it to France and to bring it to Germany you had to bring it to the UK is much much nicer to have the CE mark even though it's a lot of work up front and it does imply a lot of obligation it's much nicer to be able to do it once and have that whole family of products covered so just a thought for you not everybody agrees but that's that's my opinion for what it's worth next one there what should a manufacturer do if a retailer is requiring C e mark for a product that is not covered under a directive and our third party partner is telling us that we cannot seek the CGT mark for our product the third party partner is a No find body but will not go on record regarding their opinion you know if you're not in scope of the CE Marking directive then you can produce the declaration of Conformity that says as much if the retailer really really wants to put the CE mark on there you can give them a data plate and they can afix it if they so choose but I personally but it should not list you as a manufacturer or a caning they want to but it should not list you as a responsible party you don't want to be somebody that's attesting to conformance with things you don't have to attest the conformance with you're just gonna draw yourself in scope and frankly it's probably illegal for you to actually fix something like that because you're you're stating a conformity to a standard when there's no standard that you should be in conformance with I don't know how you would do that just want to talk about that one offline a little bit I'd be happy to except probably requires a much deeper knowledge of your fact pattern alright looks like I got time for one final one question is reach included as an applicable directive for the CE mark as of right now no reach got in there and its initial passage was just before seeing the new kind of regulatory framework really started to kick in now in earnest I can't imagine a world where reach doesn't eventually make its way in the CE Marking just because the article standards the only kind of saving grace there is that reach really is a chemical piece of legislation first it is really intended and designed to get knowledge from the chemical manufacturers and the importers of chemicals and then it just so happens that all of us article producers and manufacturers or goods get suck in there as well but the law itself is intended to focus predominantly on the chemical guys but I really would have to fathom that at some point see he's gonna get you're on in there just a matter of when and how and what form it kind of takes it looks so that would be my my humble opinion again just an opinion don't don't quote me on that alright now I see there's more apologize I couldn't get to everybody but we certainly will get back you guys an intern thank you again for your time I sure do appreciate you sitting hold a night with me and we'll get back to you as soon as possible y'all have a good day and enjoy the rest you week bye