Medical devices are subject to Directive 93/42/EEC, IVD devices are subject to Directive 93/42/EEC. Active implantable medical devices are subject to Directive 90/385/EEC. All devices must be CE-marked before entering any country in the EU.

Medical devices are divided into class I, class IIa, class IIb and class III. IVDs are divided into four categories; General IVDs, self-diagnostic, list A and list B. All medical devices exempt class I and General IVDs devices require the involvement of a Notified Body and the implementation of an quality management system, usually in line with ISO13485. Non EU manufactures without a local office in an EU member’s state must appoint a regulatory Authorized Representative. Our territory specific (*) regulatory services in the European Union include;

Medical Device specific CE Mark regulation strategy reports, CE Mark Registration of all Medical Device, IVDs and Active implant medical devices. Technical File and Design Dossier preparation, ISO13485 establishment and implementation, product validation consultation, EU Authorized Representative services and much more including Clinical Research planning and management and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill in the following form and submit your inquiry or discuss it with one of our online specialists.  Let's get your products registered in The European Union!

(*) EU Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.