Welcome to
the website from the Spanish Medical Devices
The Spanish Medical
Devices regulated by the
Directive 93/42/CEE, from these pages we will
arrive to all the people "affected" by this new european "CE mark"
in order to achieve the maximum diffusion of the information in this matter.
In general the information that appears in these pages is directed to the actors in the
new CE scene: Hospitals, Health Authorities, Manufacturers, Notified Bodies, Lab's,
doctors and users.
Please note that the transposition of the Directive to the Spanish laws is the
Royal Decree 414/1996 (and Royal Decree 1591/2009 from 21 mars 2010) which like the other
transpositions to the national laws has some particular requirements for the distribution
and sales in Spain of Medical Devices.
Thanks for your visit, as you can see nearly all the information is in Spanish and
directed to the Spanish market scenario.
If you are providing similar information directed to other
countries please contact us. We can share specific information and provide advice for
specific regulation matters in our countries.
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