General information for EU member state countries without any additional local domestic requirements.

As a member state of the European Union, medical devices and IVDs are regulated according to the relevant EU Directives:

The Medical Device Directive 93/42 EEC
The In Vitro Device Directive 98/79/EC
The Active Implantable Medical Device Directive 90/385/EEC

Devices that have CE mark under any one of these directives do not require additional registration or regulatory processes to be marketed in that country. Our territory specific (*) regulatory services in the European Union include:

Medical Device specific CE Mark regulation strategy reports, CE Mark Registration of all Medical Devices, 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’s 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 Lithuania!

(*) Lithuanian 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.