Ensuring Electronic Signature Lawfulness for Business Associate Agreement in European Union

How to eSign a document: electronic signature lawfulness for Business associate agreement in European Union

European authorised representative the European authorised representative may have different names EI r ec rep EC or C e representative just to name a few however they all mean the same European authorised representative the European authorised representative is critical for manufacturers wishing to sell medical devices on the European market legally required the EU medical device directive article 14.2 says a manufacturer that does not have a registered address in the European Union may not make his medical devices available on the EU market unless he first designated an authorised representative in the European Union how to designate an EI are by signing an agreement the manufacturer and the EI are signed agreement which essentially says one manufacturer you will be my authorized representative in Europe and two European authorised representative I accept to be our European authorised representative in addition to the agreement you will need to mention the rights and obligations of each party and the general manner of cooperation as such it is clear that designating an e AR is legally required and it is done by signing an agreement but how should the manufacturer choose an e AR in order to make the right choice the manufacturer should consider three things one who can be an e AR 2 what should an e AR do for him and 3 what are the possible risks of a bad choice who can be an e AR see below legal definition of a European authorized representative in short the e AR must be European means he must be established in the community authorised means he is designated by the manufacturer representative means he agreed to represent the manufacturer what should an e AR do for the manufacturer the e AR should one provide the manufacturer with a registered address in the EU to be mentioned on the product packaging to keep at his registered address in Europe the technical documentation available for inspection by the EU authorities 3 maintain constant availability to represent the manufacturer in front of the EU Commission EU authorities EU certification bodies and the European users for complete applications on behalf of the manufacturer device registrations free sale certificates etc 5 take care of any incident reporting 6 safeguards a compliance with regulatory news and updates and 7 consult and continuously support the manufacturer what are the possible risks here are some of the risks when designating a distributor in Europe has a our registration disagree on price or other conditions what will happen to your EU registrations when cutting relations with a distributor confidentiality disclosing your secrets technical documentation x' to a distributor conflict of interest distributors have commercial interests regulatory compliance is not at the top of their priority list competence you'll advise you on EU regulation for example will a distributor in Italy know the national laws in Poland or the UK probably not and expertise who will have the expertise to represent you during an EU Authority inspection this means the e AR must be knowledgeable and backed up by years of expertise be able to cover the entire EU market and be neutral and professional conclusion a professional agency as European authorised representative is the most recommended solution for the manufacturer makes sense here's the procedure to replace your yarn 1 the new ei R is to be designated under the signed legal mandate before terminating the agreement would be current ei R 2 the outgoing ei R needs to be notified by the manufacturer from this day forth the new ei R will take over in case of class 2a 2b or 3 medical devices the notified body needs to be notified of this change and in the case of class 1 medical devices the EU authorities need to be notified in this change questions need help with years of experience in European authorized representative services Ovilus will be your european authorised representative please visit this page for support árboles medical dotnet slash contact