Harmonized standards

October 05, 2021

Harmonized standards

In another designated Member State, private institutions have been designated, the first designation was in the year 95xi medical devices for in vivo diagnosis in 2002 after the publication of the in vitro diagnostic directive in 98 in 2002, also later designated as an organism notified for this type of football in 2012, following this path of finding evidence that gives peace of mind to third parties, not as they were ours, the control authorities of the notified bodies gave us accreditation for the certification of quality systems, one that is directly related to the process of evaluating the conformity of the products and we were.

In 2012, in 2018, in 2019, we had the designation for the medical devices directive and for the in vitro diagnostic products directive, although for the designation of the Nation of products, sanitary and implantable sanitary products, the songs ave designation was very reduced to adjust it to the technical technical capacity and the resources that we had at that time at the moment available in the notified body I knew, it gave a little to prepare us to request the designation according to the new legislation of medical devices for the MDR and and We have also recently requested the designation of the Regulation of one liter, the designation to go to the final stage remained, we hope that

The designation before the end of this year and well, in the VR because it has just started, we submitted the request to the Ministry of Health in June to the end of July 2000 of 2021 and we are waiting for them to notify us of the joint evaluation team, because weighs in theory, let's not tell you that we are dedicated to certifying medical devices, medical devices are a very large and heterogeneous group of types, they differ in their characteristics, the benefits in the mechanisms of action, so what we do is intervene to placing the market you and being CE marked is a mark that confers confidence that the product is of safe quality and also that it is effective and this mark.

sanitary ware becomes like a kind of passport so that the product can be freely marketed in any country of the European Union is the legislation of the new approach or global approach on which this legislation on medical devices is based, the directives and also the regulations acquired This same approach is based on classifying the products with a risk level and determining in which of them it is necessary for the notified body to verify that what is declared by the manufacturer is that it is based on objective evidence for low-risk products in class 1 or Class A depending on whether they are invitro or sanitary products, since the manufacturer would really put the product on the market under his sole responsibility.

go without it being necessary for any third party or health authority or notified body to confirm that it has the objective evidence that it declares with which it declares conformity to affix the CE marking and for the products are these conformity assessment procedures for the products of maximum risk, such as a pacemaker class 3 or for invitro class A products that would be the products that are used for chopping in local host of blood, since the procedures establish that the notified bodies have to make tify the product by product and to affix the CE marking as the notified body has had to confirm that the manufacturer has made the design in a planned way and in a systematic way and to identify.

perfectly, what are those tools that they used to demonstrate compliance? That is where it comes in value or in the technical standards that have been published model that I present to you in which they were all back to a little in case it really is a model that is their A fundamental pillar of trust, trust between the competent authorities, who are the ones who legislate, are established by the requirements that the notified bodies have to comply with, what are the ones that build, confirm that what is declared by the manufacturer is really based on objective evidence the manufacturers are solely responsible for the conformity of the products, the manufacturer makes a declaration of conformity, even if a notified body has intervened, the manufacturer always has to make a declaration of conformity before putting the product on the market and what this declares your product meets all the requirements and

Well, I used tools such as the standards of to demonstrate that it is indeed safe, it is of quality and effectiveness and then so trustworthy if all this gear works well, because the user of sanitary products to have confidence and that the product is indeed safe is of aesthetic quality and effectively it will be a passport if this passport in will allow you to circulate freely if there are doubts about the trust, because they may even appear a safeguard clause in some country because they doubt that a product with a CE marking by a body of a certain notified or from a specific country that is fulfilled, it is the Canary Islands with that norm that for all this because we really have this tool that Panama has already started, which is a tool.

Well, in the legislation, specifications such as common specifications appear as tools, we recommend some instructions that have the range of law, come on, that is really mandatory if there are or common specifications that are required to be respected and the notified body will be obliged to confirm and really that are produced complies with the specifications set so far the common specifications, only LG in vitro diagnostic products appeared, new legislation is expected to appear common specifications also for certain types of products of the general scope of medical devices is expected, for example, for products that are going to be regulated as medical devices, but that do not have

A final also then the next link, would be the harmonized standards. Hello European monograph, harmonized standards have a value that does exist because they are a reference for the competent authorities and therefore for the notified bodies, if a manufacturer is going to put that it intends to put a product on the market so that there is a harmonized standard either vertical or horizontal, since the fastest and most effective is that it has been determined by that harmonized standard, because it is what the public is expected to expect so much the competent authority without for a class 1 product or it also expects it than for the Notified body, if it is for products that have Masri technical standards, I pay the difference because there are no standards that are not really harmonized now.

explains the difference between what is a harmonized standard, but that in technical standards, since they take the state of consensus, the state of the art of the technique of going from all the interested parties and the parties involved and really, because it also has a value As a very very important tool, then at another level, since there would be reference documents, guide actions of any, especially the group and currently the medical device the medical device Group coordinator, which is preparing many documents to try to clarify some aspects that are not totally clear, in the claim and then the last thing because it would be by the manufacturer because because there are times that really, because there is no common specification and we are going Nice Dani a technical standard or a reference document and then from the manufacturer.

Finding a solution and confirming that it is acquittal responds to the State of the Nation in which you are connected, the higher the level of consensus of the tool that we use, the greater the ease will be to achieve credibility and trust between the parties involved is what Today I commented if Ramón has set a vertical standard for a given product, because really the easiest and the most that everyone is going to expect is that the manufacturer complies with this harmonized standard, why does it not comply to have to justify very much because I did not buy it and now, well, well, I am going to introduce the concept of a standard a bit or that I do not think it would be almost this would be unnecessary, but hey, I have taken the definition of the ISO guide on the sides of the

the technical standard includes aspects that I would like to highlight in this teaser of some concepts that are key for the standards and an adequate tool for the conformity assessment process, that is, if there is really general consensus, a lot of trust between the parts applied by a notified body that also gives credibility to that document and is also a guarantee that the state of the art of the technique of continuous and repeated use activities that ensure that the result will be an orderly result and the expected.

I mentioned before that there is also the concept of the harmonized standard in the harmonized standard, since it is a technical standard that is elaborated by the European standardizing bodies that reference body or it is because in this case it would be the bosom of the European Committee for Standardization standards and they work by an express mandate of the Commission for a legislation ending, as we can find, for example for the directive of medical devices, aA were included in this link, since the standards that have been harmonized for the directive of products and now currently Well, they are publishing, I know although the process is going, it is going a little slow as normal harmonized according to the new king.

Regulation of medical devices currently there is a short list of harmonized standards but in the coming months it is estimated that this list of standards will be enlarged because they will be precisely that the reference so that manufacturers can use them as tools to comply with the requirements I believe that one of the important aspects of this converts regulatory requirements into actions or into specific aspects of how to comply with this requirement. I have here two examples of operating requirements that appear in the Regulations. of sanitary products as for example it appears that in one of the requirement 5a it seems that the manufacturer will take into account the

technical, experience, education, training, and environment of use, as well as the medical and physical state of the intended users, the design for lay users, motor disabilities, HG, understood the LST requirement, and said, being the manufacturer, how do I agree to this requirement? a standard appears there is a standard that standard 60 62366 is a harmonized standard and that really what is application of suitability engineering for use in this standard is very specific and very detailed guidelines on how to confirm that the product that makes it really is being designed or that has been taught is suitable for that user that layman that professional or for example also the requirement of 15 1D

equipment that has a summer measurement function to show you that they provide accuracy, precision and sufficient constancy for the intended purpose because you can also do that, for example, if it is a syringe, a syringe that is used to administer medication has to fulfill this purpose. the vaccine itself, since it has a finished precision, because there appears a rule that since this requirement has turned it into concrete specifications that this attitude, what precision does a hypodermic syringe have to have, don't wait for me?

Many times also the rules one when there are rules that one when reading them, nodding his head because it really says good, because really many rules do not charge you anything at all new, but it is true that they confirm things that are meaningful as and that actually seeing them written structured, as it gives confidence and to demonstrate a requirement. Today I have brought here as an example, since the 13485 standard is a harmonized standard for quality systems in the health product sector, what is a quality system for regulatory purposes of medical devices?

Since the first active implantable medical device directive was published in 96-97, the product has been designed in a planned and systematic way and has technical documentation that shows that the product complies with the requirements set out in that legislation, but nowhere were we mandatory, I know, I do not know, I harmonize the PS4 85 quality systems standard and when they spoke they spoke of document control, because they did not really mention the technical technical documentation or the product design file, what the document is. key and that it has to be subject to control and controlled just like any other document in the system and the first.

pots in the 2016 version of this appears among the documentation submitted to control that the manufacturer must have since it must have been a medical device and a sanitary file in case the procedure requires it, which was as is so evident, It is true that many times during the auditor in one day it was difficult to ensure that the manufacturer had submitted the argumentation to adequate control yesterday simply because although it had its quality system, the documentation of the product was outside the quality system.

In any case, always the use of a harmonized standard to demonstrate the conformity of the product presupposes the conformity with the regulatory requirements provided that they are covered by this standard, there are many times that the standards are true that simply saying that you comply with the harmonized standard, what risk analysis. Well, it does not mean that your product is compliant and safe, because the standard of risk analysis for example is normal, it is systematic baby, how to do a risk analysis well to ensure that you identify all the dangers above all the rivers with all and you take all the measures, but it does not say anything about one of the criteria that a specific product has to apply, then you have to use the methodology of a standard, but the specific requirement that it is sure that it is to apply the 14971 products are not.

It would not be in accordance with the jerseys requirements, you would have to go to demonstrate another standard using others, right? For example, well, well, there if in the case that we were then wanting to put a sphygmomanometer on the market, we looked for a standard and we found that there is a harmonized standard 61 and it is also a vertical standard, right? And he says and says that, well, well and the mouth uses it, but be careful that even though it is a standard to see if it seems that we are going to have everything covered with that standard, because that harmonized standard will use it to demonstrate the essential requirements, that you cover that are covered by that standard, but for requirements requirements you will have to look for another tool that does not have this standard, for that it is very useful in the harmonized standards there is an annex pss.

In which the chapter of the standard is related to the requirement of in this case they were the directives but this requirement always comes at the end so that the manufacturer, the competent authorities and the notified bodies are clear about what requirements would be covered if conformity is declared with then good, that well take it into account, if although the standard is called a sphygmomanometer, non-invasive is a vertical standard, there are requirements that may not be covered by exam.

And here as we are in a university environment and then to finish the in the part of Norma, I do also bring up a chapter one of the chapters of the headings of the harmonized standard 13485, which says something that is like a dog. You say it physically with which. If you do not already get into the health product sector, it is already well that the design already contemplates this standard and in that standard it is said.

As an input element of the design process in medical devices, it must always appear cites a series of aspects and reminds that the regulatory requirements and applicable standards have to be present from the beginning in the design of a medical device and this the more in phases the more Early in the design of the product, the greater probability of success of the product is taken into account, there is more probability that the product reaches the market without problem because sometimes it happens that the designer begins to work towards a line without forgetting these regulatory requirements or the requirements that appear in the technical standards and when they are developed then it is difficult to go back then well, that is a harmonized standard.

When he talks about the design of sanitary products as an additional requirement compared to ISO 9000, he states that as an input element you always have to have this and the standards that may be applicable to them so as not to get surprises and in this regard the standards, well there Always as a balance tends to be that we all understand each other and that you have how you generate criteria and in that, well, you have to get there, you have to go from the type of product of the type of product of the type of technology that you apply from the Aljarafe of the process equipment and there are therefore rules that are not very deterministic, that mark a lot that mark exactly, what must be done how to make their application and inflexible and that there cannot be any type of adaptation possible or

And there is another open rule that has a flexible application and that then must be contextualized on a case-by-case basis, because in the end I would not lean towards either one or the other, I believe that both are necessary, but there are It must be borne in mind that in the end what is intended in this is that there is homogeneity of criteria, then a standard that is too open runs the risk that in the end the criteria applied by different parts, when duplicated, will not apply it in the same way form and a very rigid rule, as it may have to be cases in which it is impossible to apply.

Well, this about the rules, like what role do the rules play in the evaluations of the notified bodies. As before or in advance, because here there are several to vary with respect to the standards there are several agents that are involved the health authority, which establishes regulatory requirements manufacturer has to demonstrate compliance with those regulatory requirements the regulatory requirements are written in a text legal, they are quite often, they are very broad very general because they try to cover requirements that apply to many types of products, what the notified body has to do is verify compliance with that with the regulatory requirements if the manufacturer is standardized, then What you say about health is going to expect a product to conform if it complies with the standard, the manufacturer should use this harmonized standard and the notified body when evaluating, which will make it possible to verify whether it is a manufacturer.

Correctly applied harmonized standard In addition to all this, it is by sense as the MDR the new the new regulations on medical devices that were published in 2017 have several objectives that I have stayed with two of the objectives of the MDA that it has. homogenize criteria and my daughter and minimize interpretation divergences for this, the legal text is much more complete, more exact, more detailed than the active ones were, we are not going if you know these regulations, as they are regulations that have the order of 250 to 300 pages each one is very very detailed, has articles. They are very detailed but despite that, because some things may remain open and that will be necessary to collect in the mastermix.

That in this in these regulations what you are saying Europe is that you have to tune in, I really know the model of the legislative of medical devices and it was like confidence in it had been lost, confidence in the model of the regulations had been lost to reinforce certain aspect to regain that confidence. So the rules play a crucial role in this new stage, in this next year I am convinced that the rules will play a key role in this recovery of confidence, which is being demanded by the commission that the Member States are demanding with respect to to the application of the legislation of health products.

specifically in the legislation, since in the preamble the standards continue to maintain the nature of voluntary application of the standards, but if the directive comes, this was clearly stated in the legislation in the preamble of the regulations there are points both in that of medical devices and that He says that if the harmonized standard really exists, it is very Ramos, I say it exactly in order to recognize the important role of standardization in the field of medical devices. with regard to quality and risk management established by regulation.

although they are already voluntary in the legislation itself. Manufacturers are invited to use harmonized standards if they can use it and also explicitly state that this is also a bit of common sense, they were already being applied, but it is true that the directive always spoke of product standards and left a little out, because the processes also in a in the legal text, it appears that the harmonized standards also apply to the system and contributions and this I think is also important that it did not say so explicitly and the previous legislation, but now in the point in annex seven of the regulations where the criteria to be followed by the notified bodies appear, as there is a paragraph and the two appear that says that the notified bodies are.

use the harmonized standards as a reference, whether or not the manufacturer uses them to demonstrate conformity, with which this in the end because it will be that at least all the products that carry their conformity assessment procedure require the intervention of a notified body Well, the notified body to look with red always of the marble tenor and that because how much it is that is important that the manufacturer or in the people who develop a sanitary product with ways for its commercialization, well, they have knowledge of that beautiful that if there is standardized then The notified body uses it, I declared it, or I declared it, it will take it as a reference.

1 1 important aspects to take into account with respect to the rules that the rules that it includes must go also uses learning to use the language of the rules and how to apply the rules since they appear in most of them always appears at the beginning that explains what means each of the timescale must have a requirement requirement we all understand that it is necessary to fulfill them if or if there is not this should because it is a recommendation and can indicate a permit a possibility or a capacity this is also important to know so much for Manufacturers also like to be notified because really the baby must be a notified body would be inflexible with the should you can, because it really depends on him.

of the manufacturer or the justification of the manufacturer, as it would be acceptable or not affected the notified bodies later when verifying if it complies or does not comply, well, each one this is true that there is no back format format, but each one has tables or documents when the manufacturer presents the application the notified body asks for information on what, what is the tool that has been used to demonstrate compliance with a certain requirement and also asks for evidence and location of how it can verify that this requirement has been fulfilled then we are going to bring you here, well, for example, because he is one of the notified body, because of requirements 7, well

The first column appears the essential requirements in the second column appears so that the manufacturer Marc Márquez if the requirement is specific, the result of application to his product not then another you in the third column and we invite the manufacturer to identify us, which one has It has been the tool used to demonstrate that of requirements and in this case it would be poetry and specification, as it will have to mark specification as if there is normal bothered, the ideal would be to use the harmonized standard if there is nothing more beautiful gives you could hear a technical standard And that is why I have always known that really the higher the level of consensus of the greater the credibility and then in the last in the fourth column. We also ask that you tell us where the evidence of

Well, with the standard with the indicated standard or with the indicated protocol or the declaration of conformity with a standard must always be accompanied by objective evidence, sometimes we actually review the table of essential requirements, there are many non-technical documentation looking for the report of Go out of the tests or the verification that the product conforms to that standard, since the report has not been compiled or the report has not been made because the company thought it was a very obvious thing, because although it is very evident in Your technical documentation when you declare a norm to include this evidence from the community can be a report and then if there are trials, then the result of the trials evidently meets the acceptance criteria that may appear at night.

In the event that the manufacturer declared conformity with a standard and there are together of those standards that you do not comply with them because you do not apply them. reasonably accepted if the a photo of the general norm if the norm in the scope includes that product completes that product without any exception really his thing would be that the manufacturer had a complete compliance report at hand.

But hey, it is also true that later within the evaluation of the notified body, it is true that the standards do not always solve all the problems, the ideal thing for both manufacturers and for the notified bodies and for the competent authorities would be that everything was established and really, since the manufacturer will limit himself to the notified body to confirm, that this is the case, but they also have some limitations, which is also why the technical competence came out both in the manufacturer and in the notified bodies to resolve Some gaps that may appear in the application include some, as only good practice and general criteria, because for example, I have brought an example, right? For in the harmonized standard for determining

Well, well, the effects of the mini ING allergy action test appear, one understands that you have to set an alert limit and action limit, but there are no criteria, no recommended value, no acceptance criteria, because that has to be set Based on its results, the manufacturer and the notified body have to assess whether this solution is the alert limit and the interaction is adequate to achieve the microbial load in that product, so the microbial load is such that when it is sterilized the product, because the product that also some standards may occur that may include aspects that are not fully aligned with the provisions of the legislation.

I bring you this as an example, because what happened with the standard is 14971, because one of the aspects that included you and that for that reason was in a period that, from being harmonized, spent a time not being harmonized, why did it not cover just this really the approach of the legislation of medical devices that you to the risk estimated by the manufacturer that is identified has to be eliminated or reduced as much as possible this the norm, because you are the one who allowed the manufacturer to estimate the risks and if already The risk falls in the risk zone, he accepts, because he said that the manufacturer did not have to do anything else, because this really came to peel off that rule that was disentailed for a time and is now harmonized with the

that the criteria for the adoption of measures are to reduce, eliminate or reduce as much as possible and then really also against the limitations that do not always establish concrete criteria in terms of periodicity, test input conditions, Excel verification, appear with much In some, terms such as adequate appear very frequently enough that of course it is adequate that enough because maybe for each of us who are here the right one is different and enough is also different then well, this is happening a bit in terminal sterilization standards the old terminal sterilization process sterilization standards were much more deterministic and more rigid than the standards that are in the latest versions of the 12 o'clock versions.

We have to take it into account both the manufacturers and the notified bodies and always with the point of view, I believe that it always has to be that the process control or the product control must be sufficiently safe because in order to achieve that these safe products in the market now an aspect I also wanted to bring it to you especially now because it is I believe that what we are going to find now gives and we have been finding it for a while and not now we are not going to start it against the versión vigente de una norma no siempre es la versión armonizado ahora porque realmente ya hay pocas armonizadas para el MDR pero bueno, todavía hay muchos productos en el mercado con de acuerdo a la directiva y puede ocurrir que realmente eso que haya.

We have to take it into account both the manufacturers and the notified bodies and always with the point of view, I believe that it always has to be that the process control or the product control must be sufficiently safe because in order to achieve that these safe products in the market now an aspect I also wanted to bring it to you especially now because it is I believe that what we are going to find now gives and we have been finding it for a while and not now we are not going to start it against The current version of a standard is not always the harmonized version now because there are actually few harmonized ones for the MDR but hey, there are still many products on the market with according to the directive and it may actually happen that there is.

I believe that we are all in agreement with the current version, it is the state of the art of the technique and the updated version is the one that the European standardization has considered, what is adequate to meet the requirements then the guideline that we have as the notified bodies as long as the harmonized standards are really the reference is the harmonized standard and then specific aspects, because really if the current version is more rigid or stricter than the harmonized version, because there is no notified body, no The competent authority is going to make problems for him to apply a harmonized version that I do not know yet, which is stricter or safer or more rigid, if the opposite is true, since we could find fault in the fact that there are notified bodies.

The reference is the harmonized version and it obliges to comply with the harmonized standard, why is that what you expect in the competent authority and well, I already have to finish, simply, well that, that the one that sets standards well, really, in the end that It is a Lima tool of course, if it exists, its use must be strongly encouraged because it really is what they expect, what it is expected to be, but also with these limitations that the regulations have, since only the notified bodies have to always maintain at all times. to maintain staff with people capable of assessing, if the decisions made by the manufacturer are all, has a technical specification been applied, that is, has a harmonized standard or a consensus document been applied?

internal protocol because if it is adequate or sufficient and then it may also be in order to guarantee the homogeneous application of the donkey, sometimes the bodies notified also to this sufficiently adequate quantify it, value it and actually have internal criteria to ensure that all the company or all its clients to the ESA the application of a standard is done in a homogeneous way in everything.

Well, I end up sharing with you always the best in the aspects that we as a notified body, we always do not keep it in mind when we do the analysis and evaluation of all the products when we have not finished this is adequate it is not really suitable for us this is ours. We are saying yes or no, we are not there and saying is adequate is not adequate, in the end it is greatly conditioned by the answer that we can put together is the criterion expected by the competent authority if we answer yes, well not to seem sufficient and if we answer No, because it will seem insufficient to us and this because the manufacturer really has to answer for its products, but really the notified bodies as well.

the evaluations that they have made of these products before the designation control authorities and I, without further ado, thank you for your attention and here I leave my contact information and I am at your disposal for any comment that anything, thank you very much.

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