Remerciez-le!

Remerciez @Admin pour avoir partagé cet document gratuitement, de la manière la plus simple, en partageant sur les réseaux sociaux.

Guide emddb A short guide for using the Estonian Medical Device Database CContents Searching for a medical device from the database Noti ?cation procedure through EMDBB Typical errors and shortcomings FAQ Required documents with the application CSearching

A short guide for using the Estonian Medical Device Database CContents Searching for a medical device from the database Noti ?cation procedure through EMDBB Typical errors and shortcomings FAQ Required documents with the application CSearching for a medical device from the database The Estonian Medical Device Database EMDDB web address is https msa sm ee eng The easiest way to search for a medical device is to use database and searching by device model name It is possible to search a medical device by the manufacturer distributor authorised representative A way to save the searched data Other search options such as device type risk class etc can be applied for a more advanced search CNoti ?cation procedure through EMDBB Gaining access to the EMDDB a Logging into the EMDDB with the ID- card or by mobile-ID for Estonian citizens b In exceptional cases we can make an account manually so it is possible to log into the database with username and password If this option is selected please write to us at mso terviseamet ee with the reason why would you need the EMDDB account After logging in there is an option called ??New application ? From there please select ??Add new organisation ? and ?ll in the data ?elds with your represented company and click ??Forwards ? and ??Submit ? After that the application is submitted to the processor who has to con ?rm it Always check that the application status is ??Presented ? Otherwise it won ? t make it to the processor C If the organisation is added to the database then you will need to link yourself to it For that please choose ? New application ?? - ? Bound yourself to organisation ?? as shown below Search the organisation that you want to bound to Add the signed authorisation letter free form document from the board member of the company to con ?rm that you have rights to represent the company in the database Make sure to click forwards and submit and after that to check if the application status is ? presented ?? Otherwise the processor can ? t see and process it C When you are connected with the organisation then you should see more application options than before To see these new options select from the menu new application You can choose notify about medical device distribution in Estonia or notify about placing medical device on the market device made available on the market in the European Union for the ?rst time through Estonia C Fill in the correct form with at least mandatory ?elds and attach the necessary documents Error message ? Tootja m? ? ramata ?? - click here to solve this error Only for registration of parallel distribution linking yourself as a distributor for the device that is already in the database With these options you can add a manufactures and authorised representative data Always use ??Add existing organisation ? ?rst to check whether the company is already in