THE NEW
CE MARKING

U.S. AGENT SERVICES TO THE FDA

EUDAMED is online!

MDSS as your EC REP is registered – SRN number: DE-AR-000005430
Registration requirements are moving forward

Get yourself registered!

European Authorized Representative for Medical Device Companies

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

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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 medical device manufacturer. Without a U.S. facility, you will be unable to register your facility, list your products, or submit the FDA marketing authorization applications without designating a U.S. Agent for.

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.

MDSS NEW SERVICES

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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