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Our services enable non-EU manufacturers to access EU markets for Medical Devices, In Vitro Diagnostics, Cosmetics, and Personal Protective Equipment.
To bring Medical Devices on the European Union market, non-EU manufacturers must comply with the MDR 2017/745. It determines that all non-EU manufacturers need to appoint a European Authorized Representative (EC-REP) when launching a Medical Device on the EU-market. As your EC-REP, MedNet EC-RREP, acts as the first contact person for local authorities. Our professionals ensure that you are always up-to-date according to the latest changes in EU regulations.
DetailsNon-EU manufacturers who want to place cosmetic products in the European Union must comply with the Cosmetics Regulation No. 1223/2009, which is determining access to EU markets for non-EU cosmetic products. Therefore manufacturers need to appoint a Responsible Person to place cosmetics on the market. MedNet - as your Responsible Person - offers you all services and support to meeting the EU compliance requirements and to successfully place your products on the market.
Roll outs of Personal Protective Equipments are regulated by the PPE Regulation (EU) 2016/425. It defines the access for non-EU PPEs to the European Union and forces manufacturers as you to appoint an European Authorized Representative (EC-REP) to place you solutions on the market. As your representative partner MedNet acts as the initial contact to authorities, supports you navigating through the regulatory landscape of the Union and updates you in the latest changes of the regulations.
DetailsTo sell In Vitro Diagnostics products on the EU market, non-EU manufacturers must comply with the IVDR 2017/746 which determines market access. In this case, you must have appointed a European Authorized Representative (EC-REP). As your EC-REP partner in the field of In Vitro Diagnostics, MedNet provides all advisory and regulatory services to support you rolling out your products on the EU market.
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Our experts located in Germany povide you with all the relevant services to give your products and studies access to the market. Our interdisciplinary team has an profound knowledge of the regulations and the market to offer you effective support.
To place your Medical Devices, IVD or PPE on the European market, we act as your EC-REP. Our service: Quick and uncomplicated product registration in the relevant database(s) as well as legalizations of Free Sales Certificates for foreign markets.
We offer full service and a fast turn around for Free Sales Certificates. Including legalizations for almost every Country in the world if required.
To enable the performance study of your Medical Device or IVD study in any EU-member state, we act as your Legal Representative and assist you in obtaining rapid approval for your study.
Place all your regulatory needs into our hand:
Our intercultural team of PhD biologists and Medical Engineers will take care of your concerns - with one single point of contact and no matter which country you want to distribute into next.
