Medical Device manufacturers established in non-member countries of the EU are obliged to designate a European Authorized Representative (EC REP)

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.

Additional Services

GMDN Code Research	VIGILANCE	FREE SALES CERTIFICATE

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

The UK Responsible Person is required by the UK Authorities for Medical Devices Manufacturers located outside the United Kingdom. In order to place medical devices in the UK market, you need to appoint a UK Responsible Person (UKRP).

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

As your UKRP we will guide you through the UK requirements ensuring you are in compliance with the UK Regulation.

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

Your MDSS Team

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

The Swiss Authorized Representative is required by the Swiss Authorities for Medical Devices Manufacturers located outside Switzerland. In order to place medical devices in the Swiss market, you need to appoint a Swiss Authorized Representative (CH-REP).

The CH-REP will register Medical Devices with Swissmedic and carry out specified tasks on behalf of Manufactures who are located outside Switzerland.

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

FAST PROCESS FOR OVER 60 COUNTRIES

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

FSC Process

The CE marking 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 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 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 on behalf of the manufacturer.

Additional Services

NATIONAL REGISTRATION	GMDN CODE RESEARCH	VIGILANCE

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!

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.