We're hiring! Join our team today. Apply now.
At MedNet EC-REP, we offer extensive expertise across a diverse range of industries. Whether your focus is on medical devices, in vitro diagnostics, cosmetics or personal protective equipment, our team of regulatory specialists is well-prepared to assist you in achieving the necessary compliance for introducing and promoting your products within the European Union.
At MedNet EC-REP, we're dedicated to making your market entry a seamless success.
Our mission is clear: ensuring that your products gain effortless access to the markets of the EU, UK and Switzerland. As your trusted partner, we provide expert representation and unwavering support, tailored to the unique needs of your business. Explore how we can help you unlock the potential of these international markets.
In the European Union, medical devices play a pivotal role in enhancing the well-being of individuals and stand as one of the largest global markets. The regulation of medical devices within the EU is overseen by EU Regulation 2017/745. Engaging the services of a European Authorized Representative (EC REP) for EEA member states is a mandatory step in compliance with the European Medical Device Regulations, particularly MDR (EU) 2017/745. This ensures alignment with key aspects of the CE marking criteria.
Before introducing in-vitro diagnostic products to the EU market, ensure they comply with EU regulations for 'in-vitro diagnostics.' Non-EU manufacturers must appoint an Authorized Representative under IVDR for market access and compliance. Engaging the services of a European Authorized Representative (EC REP) for EEA member states is a mandatory step in compliance with the European Medical Device Regulations, specifically the In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746). This ensures alignment with key aspects of the CE marking criteria.
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.
Headquartered in Germany, with locations in Great Britain and Switzerland, our professionals provide services 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 support with 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.
To sell your Cosmetics in the European Union or the UK, we act as your Responsible Person and offer quick, uncomplicated registrations on the Cosmetic Products Notification Portal (CPNP) in Europe and the Office for Product Safety and Standards (OPSS) in the UK.
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.
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.
Our professional PhD biologists and medical engineers are well equipped to take care of your concerns.
Please feel free to contact us with any questions youmay have. We are here to help!
