Online Signature Lawfulness for Non-Solicitation Agreement in European Union

How to eSign a document: online signature lawfulness for Non-Solicitation Agreement in European Union

what is the European authorised representative I know this is the question that you will each time when you're walking on the street so let's give you an answer to it [Music] hey everyone I am muneerah Susie from EC medical device car and today I will teach you what is an authorized representative okay let's start first by a clarification the European authorised representative can have multiple names we can hear Pierre so for European authorised representative or EC rep or EC or CEP representative but all this means the same thing I mean the European authorised representative so let's look now at the definition of what is a European authorised representative that is coming from the medical device regulation MDR 2017 seven four five so let's stick to it let's read the definition the European authorized representative means any natural or legal person established within the Union which means the European Union who has reserved and accepted a writen mandate from a manufacturer located outside of the Union similar outside of the European Union to act on the manufacturers behalf in relation to specified tasks with regards to the latter's obligation under this regulation and the best regression means under the medical device regulation 2017 seven four five as you can see on the definition all manufacturer located outside of the Union need an authorized representative but which are the countries that are located inside of the Union let's look at that we have first the European Union which includes countries like France Germany Spain Belgium etc and also United Kingdom for now but they will soon leave because of the brexit there is also the European Economic Area that includes Norway Iceland and Liechtenstein and you have the last one which is the FTA European free trade association and it contains only Switzerland so all those countries doesn't need you notarized representative to sell their producing their you're banning you by looking at this definition you can understand that if you are located outside of the Union then you need another representative to sell your products in the European Union so what is an authorized representative in that so an authorized representative as you see on the definition is an entity that is located in the European Union it's why we said repair an authorized representative then it should be authorized as division so it means that the manufacturer has to authorize this entity to be the representative Indian and at the end they have to be the representative so they have to agree and to sign the agreement with the manufacturer to accept to be the representative of this manufacturer in the European so you see you are European authorized and representative is it enough to have an authorized representative to sell product in the Europe and Indian no we need also an importer the importer will import your products in the European Union the authorized representative will authorize those products to enter the European so you have to have those two entities to be able to sell your products in okay let's look now at what is the role and responsibilities of an authorized representative first you have to fulfil all the requirements that are mentioned on the agreement that is signed with the manufacturer this is a minimum item but on the show grammars there are some specific requirements that are coming from the EU and year 2017 seven four five what are they the first requirement is to check the documentation what means that documentation is the you the glass of Conformity the technical documentation and it has to have them available at its address up-to-date second he has to check the registration registration of one of the importer of the manufacturer of the products of himself it has also to be registered in the European Union he has to check that all those registration are up to date I'm done third it has to support the manufacturer during competent authority ordered further when the computer authority can ask for documents can ask for to see the technical documentation can ask also some documents that are under the position of the manufacturer and the authorized representative has to play the intermediary person he has to contact the manufacturer and provide those documents to the competent authority then what else should it should play also an important role for the vigilance reporter if there is anything that happens on the market like a complaint like a record at hospital it has to be the person that is executing that or the person that is informing the manufacturer about what is happened then last but not least he has also to be compliant what does it mean the manufacturer is the manufacturer is doing something wrong on the market in the European Union market it has to inform the authorized representative has to inform the authorities and it has to terminate his contract with this manufacturer but one important thing is that the manufacturer and the authorized representative are liable in case of an issue on the market it means that the autoresponder chief can also go to jail because of that so I think a lot of you are now saying that maybe they don't want to be an authorized representative where is mentioning the name of the European authoritative on your products first it's much on the level you have a logo the ICI Replogle and behind this logo you have the name of the authorised representative and its address so then the people are the customers or the competent authority can contact directly the authorized representative when there is an issue then seven the authorized representative is also mentioned on the new declaration of Conformity so this is also helpful for a competent authority to know that who is the authorized representative for this manufacturer the question that is also raised is can I change my European authorized representative and the answer is yes you can see that on article 12 of the umgo 2017 seven four five what does it say it says that you have just to appoint a new European authorized representative to sign an agreement with him and to mention on the agreement that the date of application for this new authorized herb is native will be by this time and at the same time you inform the old or European or entity that you are with doing your contract and mentioning at which date you will not be you Europe and offers a tentative anymore what is important is that when you are creating an agreement with an authorized representative this case should be mentioned also this will help to avoid europe and authorized representative to close a contract directly and put you in trouble because his name is on your Labatt's so as soon as you are changing your panel as representative you have or stop to think about all the packaging challenge or the see you declaration conformity change etc this can cost you a lot of money so you have read to think quite about that another question that is raised is should I choose my distributor as my European authorized representative my answer is no why because a new European authorised representative to be natural and independent but as your distributor has some financial interest to sell your products he is not any more neutral on independence for example during the vigilance reporting or vigilance issues that happens on the field like compliance or Rick Owens or those kind of things it can be delays some information delay some actions because he has some financial interest to sell to continue to sell those products so this can be a problem then he has also to keep at its place of forecasts address European address the technical documentation what does it mean it means that he is keeping your secrets because all the critical information are located on this technical documentation but he has to have that because it needs to have that available for the computer authority next it has also to have a regulatory compliance personal space of work it's not usual for distributor so it's an additional action for you to do and what you can do that but at the end it's not also its core competency you need to have released some professionals that are able to help you to register your products order to make any regulatory compliance activities meeting the cookies so it's really important to choose a profession of work and last but not least the name of the distributor will be on your produce now because he's your European authorized representative what does it mean it means that if you have any config videos Jupiter if you want to change the distributor you'll have them to change all your packaging you have maybe to scrub some products you have maybe to do a lot of actions that will cost you a lot of money so this is really important for you to think about it before to choose your distributor as your European authorized route do you have more question about the European authorizer presentative I've created in an article for you just look at the show notes below and see if this is this contains your question it's called pop 11 questions about the European authorised representative so I hope it will be helpful for you so as usual if you like this video so give me a thumbs up and don't forget to subscribe to my channel and click also on the on the bell that is behind just to get notified when there is a new video coming so thank you very much and see you soon