About MedNet EC-REP
MedNet is a Germany-based company that deals in the international industry of medical and pharmaceutical components and services since 1990. Beside the marketing and sale of standard components and customized material solutions, MedNet EC-REP as its subsidiary provides regulatory services for manufacturers outside the European Union, marketing their medical devices, products and clinical studies within the E.U.
As your European Authorized Representative
MedNet EC-REP acts as your legal entity towards the authorities while marketing your medical devices, active implantables, clinical studies or cosmetic products within the European Community, dealing with the obligations of the relevant medical directives. With our special experience in the complex european medical devices legislation, MedNet EC-REP provides fast study notifications and product registrations for medical devices, active implantables, in-vitro diagnostics and cosmetic products within the EU. Therefore our experts take care of the incident reporting and preparation of Declarations of Conformity as well as the application of several other Certificates.
Why MedNet EC-REP?
- MedNet and MedNet EC-REP GmbH with its unique combination of regulatory experience and expertise in addition to our marketing skills, is your best choice to provide you with the Authorized Representation services that you need for your success in Europe. For more than 10 years MedNet has performed product registrations according to the directives MDD 93/42/EEC, IVDD 98/79/EC and AIMDD 90/385/EEC and cosmetic regulation 1223/2009. We are capable of providing all the information you need in each EU Member state and can also perform individual country registrations, if necessary (Italian registration, Portuguese registration, Spanish registration). MedNet is certified in accordance to ISO 13485 and provides a certified vigilance system (incident reporting) according to the relevant directives.
- MedNet EC-REP as your Authorized Representative assists you in all issues regarding the post marketing surveillance and supports you with all obligations as well as labeling and language requirements.
As a marketing and distribution company
MedNet represents well known OEM’s from all over the world, distinguishing themselves by innovative products. Our customer base is the medical and pharmaceutical industry, but also companies producing industrial applications and worldwide markets.
- MedNet has been established in Muenster, Germany in 1990. Since then we continuously have concentrated on strengthening and expanding our network and experiences. Together with you we develop solutions which contain products and components from our principals. All our principals are noted for their outstanding competence in production, engineering and research capabilities. MedNet unites these individual strengths and herewith brings to you maximum versatility – all from one source.
- Our goal is to offer you a wide range of products combined with competent counselling. Our customers appreciate that we enhance their performance potential. Through our experience in the international market we can also assist you with overcoming cultural barriers as well as administrative and regulatory hurdles.