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U.S. AGENT SERVICES TO THE FDA

European Authorized Representative for Medical Device Companies

An Authorized Representative is a person or a legal entity in the European Community who by designation of a manufacturer acts on their behalf. An EU Authorized Representative may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of the EU directives Directive.

UK-03

Brexit News!
MDSS-UK RP Ltd. is established!

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Take advantage of
the MDR delay!

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Choose your solution for the MDR (EU) 2017/745 / IVDR (EU) 2017/746.

U.S. Agent for Medical Device & Pharmaceutical Companies

A U.S. Agent is required by the FDA, if you are a non – U.S. based manufacturer. Without a U.S. facility, you will be unable to register your facility, list your products, or submit FDA marketing authorization applications without a designated a U.S. Agent.

MDSS is your Authorized Representatives For

  • Medical Devices (MDR)
  • In Vitro Diagnostic Devices (IVDR)
  • Other European Directives & Regulations (RoHS, PPE, etc.)

ONLINE SEMINARS

Learn more about the MDR with our Seminars

GSPR Checklist

Will get you started to transition from MDD to MDR.

European Union Authorized Representative Services

Your EU Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European AR (Authorized Representative) will put your company on the forefront of European Regulatory Requirements.

Select MDSS as Your UK Responsible Person

Medical Device Manufacturers located outside the UK must use a UK Responsible Person.

MDSS SPECIALIZES IN EUROPEAN REGULATORY AFFAIRS, YOUR AUTHORIZED REPRESENTATIVE - YOUR BEST ADDRESS!

An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European Representative will effectively put your company on the forefront of European
Regulatory Requirements.

Covid-19 Notice

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