Authorized Representative in EU

Authorized Representatives For Medical Devices (MDD), In Vitro Diagnostic Devices (IVDD) Active Implantable Medical Devices (AIMDD) the appointment of an Authorized Representative for the Member States for the EEA is required in the European Medical Devices Directives (Medical Device Directive 93/42/EEC; Active Implantable Medical Devices 90/385/EEC; and, In Vitro Diagnostic Medical Device Directive 98/79/EEC). 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.

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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.

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 make use of our vast stores of research materials, news, information and articles on Authorized Representation, Medical Device Directives, IVD Directives and AIMD Directives and 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 ( http://ec.europa.eu/enterprise/sectors/medical-devices/index_en.htm and/or any national website for the latest regulation news. In order to get any advice on a particular aspect you may consult our News & Views. Most certainly please contact MDSS directly for any latest information and advice.

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