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Explore new market opportunities with MedNet EC-REP: Providing Authorized Representative Services, we empower international manufacturers to gain entry into the European Union, the United Kingdom, and Switzerland. Whether your goal is to introduce a product to the market or undertake research, MedNet EC-REP efficiently manages all your regulatory requirements under one roof.
Selling in the European Union as well as in Northern Ireland, your product has to comply with the respective EU regulation. This regulation forces non-EU manufacturers to appoint an Authorized Representative based in the region. MedNet offers representation services for Medical Devices, In Vitro Diagnostics, Cosmetics and Personal Protective Equipment supporting you in all regulatory needs to place your product on the market, conduct a Clinical Investigation for your Medical Device or a Performance Study for your In Vitro Diagnostic. Based in Germany, our professionals have current regulations for all EU-member states in mind to provide you the best regulatory support and guarantee quick registrations for an easy and uncomplicated access to your target countries.
DetailsSince Brexit, the British market is no longer part of the EU anymore and is now regulated by its own regulations. If you are placing products or conducting studies in England, Scotland and Wales, your products must comply with these regulations. In addition, non-British manufacturers need to appoint a UK Responsible Person (UK RP) based in the region. Our office in Great Britain acts as your UK Responsible Person offering non-British manufacturers representation services for Medical Devices, In Vitro Diagnostics and Cosmetic products to enable a quick and uncomplicated access to the British markets.
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To gain access to the Swiss market, you have to ensure that your product complies with the local Swiss regulations. These regulations force non-Swiss manufacturers to appoint a Swiss Authorized Representative who will be the first point of contact with Swissmedic, the local regulatory authority. MedNet represents you in all regulatory needs to easily register your Medical Devices and In Vitro Diagnostics in the Swiss database and to handle regulatory issues to ensure the compliance for your products.
DetailsHeadquartered 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.
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 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.
