Medical Device manufacturers established in non-member countries of the EU are obliged to designate a European Authorized Representative (EC REP).
Appoint MDSS GmbH to perform National Registrations on your behalf!
Outsourcing registration processes and delegating this obligation to MDSS GmbH helps you to keep the highest business flexibility in your distribution network. We guarantee that all information and documentation will be handled with utmost confidentiality.
Medical Device Registration:
Italy, Spain, France, Portugal, Latvia, Greece, Slovakia, Croatia, Lithuania and other countries.
The Global Medical Device Nomenclature (GMDN) is a widely used nomenclature for generic identification of medical devices.
For example the Italian National Registration and Spanish National Registration databases require GMDN codes and the codes can be utilized for the European medical device databank EUDAMED.
The GMDN system is maintained by the GMDN Agency. Manufacturers and other interested parties can become members of the agency and get access to the GMDN terms. However, for this service the GMDN Agency charges an annual membership fee (for details see the GMDN Agency website). Also, the research of an applicable code for your product might prove a time-consuming task if you are left alone with it
MDSS can help you with selecting the appropriate GMDN code, without you needing to become a member of the GMDN Agency. We also offer to assist you with applying for a new GMDN code, if no suitable code does exist yet.
Have MDSS assist you with the choice of an adequate GMDN code.
MDSS will also be able to help you with the implemented or upcoming medical device registration requirements in other EEA countries.