New IVD Requirements
Following Obelis European Authorized Representative Center’s (O.E.A.R.C.) meeting with the Belgian IVD European Competent Authorities held on Monday, 12 September 2005, European Authorized Representatives are now required to take the necessary steps to notify all 25 EU Member State Competent Authorities of IVD Medical Devices available by their clientele in the EU territory.
This requirement is effective immediately and the 10 new Member States’ Competent Authorities must be informed of all IVD Medical Devices that have already been registered within the 15 EU Member States.
Obelis O.E.A.R.C. has over 17 years of experience offering superior regulatory compliance consulting to manufactures of medical devices worldwide. Contact us for more information.
Please visit Obelis, s.a. at Medica 2005 in Hall #13, Booth #A14.
Obelis, s.a. O.E.A.R.C.
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