MDSS GmbH

Schiffgraben
41
Hannover,  30175

Germany
https://mdss.com/

• Booth: 2363

Established in 1994 with over 30 years of expertise, MDSS is a leading Authorized Representative for In Vitro Diagnostics and Medical Devices, specializing in Regulatory Affairs. Certified to EN ISO 13485, we serve as the main contact for EU Competent Authorities, MHRA, Swissmedic, FDA and TGA. Our services, among others, include EU and Swiss Representation, UK Responsible Person, U.S. Agent and Australia Sponsor, ensuring your company's forefront position in regulatory compliance.

 Press Releases

• UK Responsible Person (UKRP) (Apr 26, 2024)

  Place Your Medical Devices in the UK Market with the MDSS-UK Responsible Person Service!

  The UK Responsible Person (UKRP) is required by the UK Authorities for Medical Devices & In Vitro Diagnostic Medical Devices Manufacturers located outside the UK. In order to place medical devices in the UK market, you need to appoint a UKRP according to the Medical Devices Regulations 2002.
  
  "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. "

  MDSS is ready to support Medical Device Manufacturers located outside the UK. 

  Our experienced team of Regulatory Affairs experts will guide you through the requirements of the MHRA (Medicines and Healthcare products Regulatory Agency).

• Swiss Authorized Representative (CH-REP) (Apr 26, 2024)

  Place Your Medical Devices in the Swiss Market with the MDSS Swiss Authorized Representative Service!

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

  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.

  As your Swiss Authorized Representative (CH-REP) we will guide you through the Swiss requirements ensuring you are in compliance with the Swiss Regulation.

• U.S. Agent to the FDA (Apr 26, 2024)

  for Medical Devices and IVDs Manufacturers

  A Federal Food and Drug Agency Agent (U.S. Agent) is the representative for Medical Devices and IVDs companies without a presence in the United States. Companies without a presence in the U.S. are required by the FDA to appoint a Registered FDA U.S. Agent. 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.

  "The U.S. Food and Drug Administration Agent requires any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment "

  With a quarter century of experience as a European Authorized Representative for Medical Devices, IVDs and Cosmetics Manufacturers, MDSS has the professional experience, knowledge, and drive to make certain acting as your U.S. Agent will lead to your success in the United States.

  Our fully staffed office in the United States is capable of handling all your U.S. FDA needs, with the same efficiency, confidentiality, and speed as our offices in Europe, United Kingdom and Switzerland.

• Australian TGA Sponsor (Apr 26, 2024)
  Medical device and IVD manufacturers situated outside Australia are required to appoint an in-country representative, known as an Australian Sponsor or Australian TGA Sponsor, who will include your devices in the Australian Register of Therapeutic Goods (ARTG). 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.

  Australian TGA Sponsor Responsibilities and TGA Registration

  As specified by the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002, the Sponsor serves as the liaison between the manufacturer and the Therapeutic Goods Administration (TGA). The Sponsor takes on regulatory representation for your devices within the Australian market and undertakes the responsibility of registering the devices with the TGA

  Whether you are a small start-up or a multinational corporation, MDSS AU Pty Ltd is dedicated to assisting you in achieving your market objectives in Australia.

• European Authorized Representative (EC REP) (Apr 26, 2024)

  for Medical Devices and In Vitro Diagnostic Devices

  The appointment of an European Authorized Representative (EC REP/AR) for the Member States of the EEA is a requirement of the European Medical Device Regulation – MDR (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation – IVDR (EU) 2017/746 for all Medical Devices & In Vitro Diagnostic Medical Device Manufacturers located outside the EU to fulfill one aspect of the requirements for CE marking.

  The importance of a European Authorized Representative (EC REP)!

  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!