European Authorized Representative for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746)
The appointment of an European Authorized Representative (EC REP) for the Member States of the EEA is a requirement of the EuropeanMedical Device Regulations - Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746), to fulfill one aspect of the requirements for CE marking.
To support you during this turbulent times, MDSS has been working hard to provide the most suitable options for all manufacturers to be in compliance with the European Medical Device (MDR (EU) 2017/745) and In-Vitro Device Regulation (IVDR (EU) 2017/746).
The Swiss Authorized Representative is required by the Swiss Authorities for Medical Devices Manufacturers located outside of Switzerland. In order to place medical devices in the Swiss market, you need to appoint a Swiss Authorized Representative (CH-REP).
As your CH-REP we will guide you through the Swiss requirements ensuring you are in compliance with the Swiss Regulation.
For further information click here. You will be directed to our website dedicated to this service.
MDSS GmbH, your Authorized Representative (EC REP), offers support during the whole process of applying for a Free Sales Certificate (FSC) / Certificate of Free Sale (CFS) / Certificate of Marketability for non-European countries.
The MDSS team can also support with a FSC application with the UK and Swiss Authority!
The CE mark is an indication to show conformity to all obligations for medical devices, as required by the Medical Devices Regulations.
However, for entering certain non-EU markets a FSC / CFS must be provided by the manufacturer. It demonstrates, from the government point of view, that you place your products legally, with the CE mark, on the European market.
The European FSC / CFS, is issued by the Competent Authority of the EU member state where the “manufacturer” or his EC REP has his registered place of business. If the manufacturer is not situated in Europe only theEC REP is able to obtain the FSC /CFS on behalf of the manufacturer.
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
MDSS will also be able to help you with the implemented or upcoming medical device registration requirements in other EEA countries.
MDSS provides training to build up the knowledge base needed for the implementation of the MDR. This is also recognized by the EU and via our local state of lower Saxony MDSS was given a grant for its efforts. We are proud to display the plaque on our building to advertise these measures. It specifically states support for the external training done with TUV as QMS Auditor for the medical devices industry.
Dercia Gois, Senior Consultant at MDSS, responsible for our vigilance department completed this extensive training program. Appointed as Safety Officer according to the German law and with finalizing her QMS training, she will take over the PRRC function for our clients.