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are you a stakeholder in the eyes of mdr are you an economical operator in relation to the mdr why should you care because if you are watching this video you are probably one stakeholder as defined by the mdr and if you are different requirements will apply to you depending on what you do [Music] hi i am ponto sierra i used to work as a lead auditor on the mdr for a notified body for quite a few years you are watching a video that's part of my course introduction to mdr the medicaid device regulation in this video i will walk you through the different stakeholders of the mdr so you can check which role you should be playing do you need a full course on the mdr or course certificate please register on my full online course by following the link in the video description below but you can also visit medicaredevice82.com and see all of our courses you don't want to be missing out on training records the next time you are audited by a notified body would you and if you haven't done it already subscribe to our youtube channel and make sure to click on the notification button so you always know when a new video is out now without further ado let's dig right in the main stakeholder is probably the manufacturer and they also represent an economical operator but of course the manufacturer is not the only stakeholder or economical operator in relation to the mdr here and listed below this video you can see the most important stakeholders in relation to the mdr starting at the top left with the european commission the european commission or just ec is the executive branch of the european union responsible for enforcing eu laws directing the union's administrative operations and proposing legislations any adopted and published legislation then needs to be implemented in all the eu member states like for example the mdr and the member states are basically all the countries in the european union moving on from the beginning then with the competent authority beginning is of course not really correct since this is basically a never-ending relationship there is no documented definition of a competent authority in the mdr nevertheless it shall be understood as the part of a country's authority or authorities that have been pointed out in the national law as being responsible for medicaid devices in that member state here i would like to take the opportunity to inform you about another interesting european publication called the blue guide the blue guide explains how the european market is defined and basically how it's governed it also includes explanations on terms like placing on the market or putting into service you find a link to this document under this video continuing then with the notified bodies the notified bodies are companies designated by a competent authority in a member state and they are kind of the authority's extended arm for controlling the european market access for manufacturers of medicaid devices except for those manufacturers of pure class 1 devices that don't need a notified body the manufacturer or as sometimes called the legal manufacturer just for clarity is the natural or legal person responsible for the actual medical device before and after placing it on the market and the manufacturer assures compliance to the mdr by applying the cemark to their products authorized representative or sometimes called ec rep is basically a european operator appointed by a medical device manufacturer outside the european union to act in their name regarding specific european requirements you may find the symbol with ec and rep on the label of the medical devices indicating who the european authorized representative is still with me so the manufacturer outside eu needs this authorized representative but also they need a defined importer so let's continue with that importer is a european operator that imports mediga devices from a manufacturer outside of the european union and thereby also takes on some responsibilities regarding the devices please note that the importer and the ec rep can be the same or different operators distributor that is an operator that is basically selling the medicare device to the users or retailers and is defined in the mdr as any natural or legal person in the supply chain other than the manufacturer or the importer that makes a device available on the market up until the point of putting it into service health institutions this means an organization with the primary purpose of the care or treatment of patients or the promotion of public health health institutions are also affected by some requirements in the mdr such as for example custom-made devices potential reprocessing or re-sterilization of medicaid devices and some requirements for traceability and special cases so now we're getting close to the really interesting person you and me in mdr user means any healthcare professional or layperson who uses the device then the patient maybe doesn't need any further explanation since it's quite obvious that this is the human being that receives the treatment of the medicare device and actually there is no exact definition of patient in the mdr so always try to keep in mind when working with medicaid devices that we all can be users and patients of medicare devices even if we most likely don't want to be the patients of course okay now some of these stakeholders are defined as economical operators ing to mdr this is kind of important to understand since they are referenced quite frequently in the mdr and have some specific requirements to fulfill so here is the list of the economical operators and please note that the competent authorities notified bodies and health institutions are not considered economical operators and of course the users and patients are not either that was a short introduction to the different stakeholders and the economical operators i hope watching this video helped you understand stakeholders better if there's anything you didn't understand or something you'd like to share feel free to drop a comment below i'd love to talk to you if you like this video do share it with your friends and your network within the medicare device industry speaking of network are you on linkedin if you are make sure to connect with me or follow medical device hq thanks for watching once again and i'm looking forward to seeing you here next time [Music] you