European Authorized Representatives
Authorized Representatives For:
Medical Devices (MDD), In Vitro Diagnostic Devices (IVDD), EC REP & CE Mark
The appointment of an Authorized Representative for the Member States for the EEA is required in the European Medical Device Directives (Medical Device Directive 93/42/EEC, Active Implantable Medical Devices 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EC).
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.
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 perfection.
Our AR Services (Authorized Representative Services) encompass the entire range of Authorized Representative Services designed to help your business thrive in these turbulent times:
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 perfection.
Our AR Services (Authorized Representative Services) encompass the entire range of Authorized Representative Services designed to help your business thrive in these turbulent times:
- National Registration
- Free Sales Certificate /Certificate of Marketability
- Clinical Evaluation
- CE Mark Services
- European Community Representative Services (EC Rep)
We invite you to visit all the pages of our web site, learn about MDSS and how MDSS can be of service to you and your company. We encourage you to browse our vast stores of research materials, news, information and articles on CE Mark, Authorized Representatives, Medical Device Directives (MDD), In Vitro Diagnostic Medical Device Directive (IVDD) and Active Implantable Medical Device Directives (AIMDD) plus links to other EU and regulatory affairs Authority web sites.
Caution: Due to the rapid changes of the European regulation, the MDSS website may not be up-to-date with its information in all areas.
Therefore, always refer to the Commission website (please click and you will be automatically directed to our link section) and/or any national website for the latest regulation news.
You may consult our News & Views section for the most frequently asked questions. To get advice on a particular aspect please contact MDSS directly.
MDSS is a member of the European Association of Authorized Representatives and certified in accordance to ISO 13485
Caution: Due to the rapid changes of the European regulation, the MDSS website may not be up-to-date with its information in all areas.
Therefore, always refer to the Commission website (please click and you will be automatically directed to our link section) and/or any national website for the latest regulation news.
You may consult our News & Views section for the most frequently asked questions. To get advice on a particular aspect please contact MDSS directly.
MDSS is a member of the European Association of Authorized Representatives and certified in accordance to ISO 13485