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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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