Authorized Representative Services
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European Authorized Representative (EC REP)


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 European Medical 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.

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UK Responsible Person (UKRP)


MDSS-UK RP Ltd. is established!

Ready to support Manufacturers to Place Your Medical Devices in the UK Market

The UK Responsible Person will register Your Medical Devices with the MHRA and carry out specified tasks on behalf of Manufactures who are located outside the UK.

For further information click here. You will be directed to our website dedicated to this service.

Your MDSS Team

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Swiss Authorized Representative (CH-REP)

Swiss Authorized



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.

Your MDSS Team

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MDSS, your Authorized Representative (EC REP / UKRP / CH-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 support with a FSC application with the EU, UK and Swiss Authority!


BangladeshBelarusBoliviaBosnia and Herzegovina
BrazilChileColombiaCosta Rica
Dominican RepublicEcuadorEgyptEl Salvador
Hong KongIndiaIndonesiaIran
NicaraguaNigeriaNorth MacedoniaOman
PhilippinesQatarRussiaSaudi Arabia
SerbiaSingaporeSouth AfricaSouth Korea
Sri LankaTaiwanThailandTunisia
TurkeyUkraineUnited Arab EmiratesUruguay

If you would like to apply for a FSC / CFS for a country not listed above let us know and we will find out the requirements for it.

FSC Process

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-European 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 FSC / CFS is issued by the Competent Authority of the country where the manufacturer or his EC REP / UKRP / CH-REP  has his registered place of business. If the manufacturer is not situated in Europe, only the EC REP / UKRP / CH-REP is able to obtain the FSC /CFS on behalf of the manufacturer.

Additional Services


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MDR and IVDR Services - The MDSS Solution!

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).

Choose Your Best Solution!

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GMDN Code Research

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.  


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National Registration

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.

Registration Steps

Additional Services

GMDN Code Research

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The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.  

Thanks to our consulting services, we guide your company safely though the jungle of laws, standards, directives and regulations.  
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QMS - Safety Officer... the way to PRRC

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.

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  • UK Responsible Person

    6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK

    +44 7898 375115

  • U.S. Agent

    IL 60630

    +1 (312) 975-1694

  • Cosmetics Responsible Person

    Schiffgraben 41
    30175 Hannover

    +49 511 6262 8630

  • CH-REP

    Laurenzenvorstadt 61
    5000 Aarau

  • Importer

    Limmerstraße 15
    30451 Hannover

    +49 511 62 62 86 30


Schiffgraben 41
30175 Hannover


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