About MDSS

Superior Authorized Representative Services
and Your Best Address.

As an Authorized Representative, MDSS is the main contact for the European Commission, National Competent Authorities, MHRA, Swissmedic and FDA, and is your EU, UK, Swiss and US Authorized Address. Founded in 1994, MDSS pioneered European Representation, and is well known and respected with the Competent Authorities. As your Authorized Representative, MDSS handles sensitive tasks within the Competent Authorities with integrity and perfection, which enables us to achieve the best solutions for you.

Appointing MDSS as your European and Swiss Authorized Representative, UK Responsible Person and U.S. agent will effectively put your company on the forefront of Regulatory Requirements.

MDSS specializes in European Regulatory Affairs; and, as your Authorized Representative MDSS offers you a first-class Authorized address in the EU, UK, Switzerland and US.

Our Services

As Your European Authorized Representative, UK Responsible Person, Swiss Authorized Representative and U.S. Agent, MDSS is responsible for your products in Europe and in the US.

Our services are an extension of your quality system, fulfilling your regulatory obligations in Europe.

Medical Device Regulation - MDR (EU) 2017/745
In-Vitro Device Regulation - IVDR (EU) 2017/746
Medical Device Ordinance - MedDO
In-Vitro Device Ordinance - IvDO
Medical Device Regulation - UK MDR 2002

Our clients

MDSS serves both the Medical Device and the In Vitro Medical Diagnostic industries worldwide. Our distinguished clients are successful in their local marketplace and have expanded their expertise into the European arena with MDSS as their Regulatory Partner.

MDSS establishes respect and mutual confidence with clients to get the best results. The combined expertise of our clients and MDSS forms alliances, which ensures success in the marketplace.

MDSS Provides

MDSS’ unique professional expertise on Regulatory Affairs of CE Marking for your Medical Devices includes:

  • Authorized European and US Address – your first class address
  • Representation of our clients to the European Commission and National Competent Authorities, MHRA, Swissmedic and FDA
  • Product Vigilance with Incident reporting and Advisory Notices
  • Registration of your products with the EU, UK, Swiss and US Authorities
  • Verification on product classification
  • Assistance with Conformity Assessment Procedures
  • Assistance with Quality Assurance Systems (EN ISO 9001, ISO 13485…)
  • Safety Officer for Germany and other applicable states
  • Advise on technical documentation with Essential Requirements, Risk Analysis and Labeling
  • Declaration of Conformity
  • Updates on European Regulatory Affairs and identifying compliance strategies

The Significance of the best Representation

Medical Device companies situated outside the EU, UK and Switzerland must designate an “Authorized Representative” in order to fulfill certain requirements under the Medical and In Vitro Diagnostic Device Regulations.

The Authorized Representative is the main contact for the European Commission and the National Competent Authorities, the MHRA and Swissmedic. The Manufacturer is required to provide access to the Technical Documentation and must include the address of the Authorized Representative with the product.

MDSS is well known and respected with the Competent Authorities, which enables us to achieve the best solutions with your interests in mind. We handle sensitive tasks with the Competent Authorities with integrity and perfection.

The Team of MDSS has a comprehensive knowledge based on significant Regulatory and Industry experience. Our team includes Physicians, Engineers, and Laboratory Technologists, dedicated and highly motivated to provide the best customer service for our clients.

Independently operated, MDSS avoids any conflict of interest, in regards to or concerning confidential trade and product information.

MDSS successfully implemented a comprehensive quality system certified to the particular medical requirements of DIN EN ISO 9001. MDSS was reviewed distinctively on the aspect of the Authorized Representative and received a certificate on “authorized representation” in accordance with all Medical Device Regulations.

MDSS stands for continuity and safety throughout the European Community with experience and stability.

MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA) and Swiss Medtech and certified in accordance to ISO 9001.