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Explore seamless market access for Personal Protective Equipment in the EU with MedNet EC-REP GmbH. As your Authorized Representative, we navigate regulatory complexities, ensuring compliance with EU directives and regulations. Trust us to handle documentation, communication with authorities, and post-market surveillance, allowing you to concentrate on product innovation and quality. With our expertise, your journey to EU market entry is streamlined and efficient.
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.
Headquartered in Germany, with locations in Great Britain and Switzerland, our professionals provideservices throughout Europe, acting as your EC-REP, UK RP and CH-REP. With over 25 years of experience and an interdisciplinary team, we provide expert supportwith a profound background of current regulations in each country you are targeting.
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 carry out fast and straightforward registrations in all EU member states, as well as in Great Britain and Switzerland.
We offer full service and a fast turn around for Free Sales Certificates. Including legalizations for almost every Country in the world if required.
Place all your regulatory needs into our hand:
Our 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.
