MDSS specializes in European Regulatory Affairs, your Authorized Representative - 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.
As the 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 service is an extension of your quality system, fulfilling your regulatory obligations in Europe.
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 successfully implemented a comprehensive quality system certified to the particular medical requirements of DIN EN ISO 13485. MDSS was reviewed distinctively on the aspect of the EC REP 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 GmbH is a member of the European Association of Authorized Representatives (EAAR)and certified in accordance to ISO 13485.