Free Sales Certificate Requirements
According to the European IVD Directive 98/79/EC, CE marked and properly registered IVD medical devices in all 25 EU member states have free access to the EU market (according to Article 10 IVDD 98/79/EC). However, it should be noted that this requirement is only applicable for the 25 EU member states. Some of our clients have recently received requests from their customers in non-EU countries for Free Sales Certificates issued by a European Competent Authority.
In an effort to continually help our clients penetrate into global markets by meeting specific requirements, we would like to inform you that Obelis European Authorized Representative Center (O.E.A.R.C.) can assist you in obtaining a personalized Free Sales Certificate to present to your non-EU member state clients requesting such certification.
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.
34 Avenue de Tervuren, Bte 44
B-1040 Brussels, Belgium
Telephone : +(32) 2 732-5954
Fax : + (32) 2 732-6003
Email : firstname.lastname@example.org