European Authorized Representative
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 and In Vitro Diagnostic Medical Device Regulation for Medical Devices & In Vitro Diagnostic Medical Devices Manufacturers located outside the EU.
Products & Services
U.S. Agent
MDSS
Your FDA US Agent must be a United States Resident or maintain a place of business within the United States. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours. 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.
UK Responsible Person
MDSS
The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations... this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
Our experienced team of Regulatory Affairs experts will guide you through the requirements of the MHRA (Medicines and Healthcare products Regulatory Agency).
Australian TGA Sponsor
MDSS
This TGA Sponsor assumes a critical role in both the device registration process and post-market compliance activities. Hence, it is vital to choose a highly competent and independent representative. MDSS AU Pty Ltd, with its physical presence in Sydney, Australia, offers comprehensive Australian TGA Sponsor services to aid manufacturers of Medical Devices and IVDs in navigating the ARTG registration process for their devices.
Swiss Authorized Representative
MDSS
A Swiss Authorised representative; “natural or legal person in Switzerland who has been mandated in writing by a manufacturer established in a foreign country to act on the manufacturer’s behalf in relation to specified tasks in accordance with Art. 4 para. 1 let. g from MedDO and with Art. 4 para. 1 let. f from IvDO."
As a Swiss Authorized Representative, MDSS CH GmbH is the main contact for the Swiss Authority. MDSS CH GmbH is responsible for the formal and safety-related issues connected with the placing of medical devices in the Swiss market.
We will guide you through the Swiss requirements ensuring you are in compliance with the Swiss Regulation.
Description
The European Authorized Representative (EC REP) is a person or a legal entity who by designation of a manufacturer acts on their behalf. Your Authorized Representative is the main contact for the National Competent Authorities and performs certain duties under the European Medical Devices Regulations acting as the legal interface between you, the Medical Device manufacturer and the EU Authorities. An Authorized Representative may be addressed by authorities and bodies, instead of the manufacturer themselves, with regards to the requirements of the Medical Devices Regulations
Appointing MDSS as your EC REP will set your company on the forefront of European Regulatory Requirements. We meet the full EU criteria for CE marking and, most importantly, MDSS has long-term experience in Regulatory Affairs necessary to provide this demanding and `highly responsible´ Authorized Representative service!
Appointing MDSS as your EC REP will set your company on the forefront of European Regulatory Requirements. We meet the full EU criteria for CE marking and, most importantly, MDSS has long-term experience in Regulatory Affairs necessary to provide this demanding and `highly responsible´ Authorized Representative service!
