Join our training program!

Current positions available:

• Account Administrator

Please send your application documents  by email to Ms. Villanueva-Moeller

 (e.villanueva-moeller@mdssar.com).

MDSS GmbH 

Superior  Authorized Representative Services and Your Best EU Authorized Address.

An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European Authorized Representative will lift your company to the forefront of European Regulatory Requirements.

MDSS, based in Hannover since 1994, pioneered European Authorized Representation and is well known and respected with the Competent Authorities, which enables us to achieve the best solutions with your interests in mind. As your Authorized Representative, MDSS handles sensitive tasks within the Competent Authority with integrity and perfection.
MDSS forges powerful alliances and provides timely, comprehensive solutions for our clients´ protection, benefit and corporate endurance. We strive to provide the best representation in the ever changing maze of European Regulations.

Our Services

As Your European Authorized Representative (EC REP), MDSS is responsible for your products in Europe according to the:

• Medical Device Regulation (MDR (EU) 2017/745)
• In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746)
• Other European Directives & Regulations (RoHS, PPE, etc.)

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

MDSS Provides

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

• Authorized European Address - your best address
• Representation of our clients to the European Commission and National Competent Authorities
• Product Vigilance with Incident reporting and Advisory Notices
• Registration of your products with the EU 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 European Union must designate an "Authorized Representative"  (EC REP) in order to fulfill certain requirements under the European Medical and In Vitro Diagnostic Device Regulations.
The Authorized Representative is the main contact for the European Commission and the National Competent Authorities. The Manufacturer is required to provide access to the Technical Documentation and must include the address of the Authorized Representative with the product.

Appointing MDSS as your European Representative (EC REP) will effectively put your company on the forefront of European Regulatory Requirements. MDSS pioneered European Representation.

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

MDSS GmbH is a member of the European Association of Authorized Representatives (EAAR).