"MDSS - Your Best European Authorized Address"
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.
MDSS pioneered European Representation
and is well known and respected with Competent Authorities, which
enables us to achieve the best solutions with your interests in mind. We
handle sensitive tasks with the Competent Authority with integrity and
MDSS specializes in European Regulatory Affairs, your Authorized Representative - your first class address.
As the European Authorized Representative, MDSS is responsible for your product in Europe according to the:
- Medical Device Directive (MDD) 93/42/EEC
Active lmplantable Medical Device Directive (AIMDD) 90/385/EEC
In Vitro Diagnostic Medical Device Directive (IVD) 98/79/EC
Our service is an extension of your quality system, fulfilling your regulatory obligations in
MDSS' unique professional expertise on Regulatory Affairs of CE Marking for your Medical Devices includes:
- Authorized European Address - your first class 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
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.
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.
The Significance of the best Representation
Medical Device companies situated outside the European Union must designate an "Authorized Representative" in order to fulfill certain requirements under the European Medical and In Vitro Diagnostic Device Directives.
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 will effectively put your company on the forefront of European Regulatory Requirements. MDSS pioneered European Representation.
MDSS is well known and respected with
Competent Authorities, which enables us to achieve the best solutions
with your interests in mind. We handle sensitive tasks with the
Competent Authority 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
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 13485:2007. MDSS was reviewed distinctively
on the aspect of the Authorized Representative and received a
certificate on "authorized representation" in accordance with all Medical Device Directives.
MDSS stands for continuity and safety throughout the European Community with experience and stability.