MDSS group

European Authorized Representative (EC REP) for medical devices according to CE Regulations (MDR 2017/745 and IVDR 2017/746) and European Regulatory Affairs.

Swiss Authorized Representative (CH-REP) according to the MedDO and IvDO.

UK Responsible Person (UKRP) according to the UK MDR 2002.

U.S. Agent to the FDA.

MDSS GmbH logo
MDSS USA LLC logo
MDSS UK RP Ltd
MDSS CH GmbH logo
MDSS Impex GmbdH logo
MDSS Cosmetics logo

MDSS Services

  • 1st European Authorized Representative
  • More than 25 years of experience
  • Market leader in EU, UK, Switzerland and in FSC
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EC REP

EUROPEAN AUTHORIZED REPRESENTATIVE
For Non-EU based Medical Devices Companies.
MDSS GmbH assists the EU Registration with the European Authorities

U.S. AGENT SERVICES TO THE FDA

U.S. AGENT

UNITED STATES AGENT
For Non-U.S. Medical Device & Pharmaceutical Companies.

MDSS USA LLC provides services and assistance for the US Registration required by the FDA

UKRP SERVICES UK RESPONSIBLE PERSON

UKRP

UK RESPONSIBLE
PERSON

For Non-UK based Medical Devices Companies.
MDSS-UK RP Ltd. provides services for the UK Registration with the MHRA

SWISS AUTHORIZED REPRESENTATIVE

CH-REP

SWISS AUTHORIZED REPRESENTATIVE
For Non-Swiss based Medical Device Companies.
MDSS CH GmbH assists the Swiss Registration with Swissmedic

MDSS import service

IMPORT
SERVICES

MDSS-Impex GmbH
is a company in Germany that places devices from a third country on the European Union market qualifying itself as importer

MDSS cosmetics service

COSMETICS RESPONSIBLE PERSON

MDSS Cosmetics provides services for the Cosmetics Responsible Person Representation with the EU and UK Authorities through the Cosmetics Regulations

Medical Device News and Views

The latest news and updates on medical devices in EU and US

MDSS - EU Rep in the USA

EUDAMED is online!

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

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

innovation

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.

MDSS Group is your Authorized Representative and Responsible Person for

  • Medical Devices (MDR/MedDO/UK MDR 2002)
  • In Vitro Diagnostic Devices (IVDR/IvDO/UK MDR 2002)
  • Cosmetics
  • 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) for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746) will put your company on the forefront of European Regulatory Requirements.

UK Responsible Person for Medical Device Companies.

Medical Device Manufacturers located outside the UK must appoint a UK Responsible Person to place devices in the UK market. Select MDSS as Your UK Responsible Person (UKRP).
MDSS is ready to support Medical Device Manufacturers located outside the UK as trade with the UK has changed significantly. The need for a UK Responsible Person is now a requirement and MDSS understands the new UK marketplace.

Other Services

MDSS SPECIALIZES IN EUROPEAN REGULATORY AFFAIRS - YOUR EU AND SWISS AUTHORIZED REPRESENTATIVE, UK RESPONSIBLE PERSON AND U.S. AGENT - 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.

Immediately upon implementation of the requirements, MDSS acts as UK Responsible Person (UKRP) and Swiss Authorized Representative (CH-REP) via our subsidiaries.

MDSS is also specialized in FDA and provides the U.S. Agent service.

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