Why should you work with I3CGLOBAL as your European Authorized Representative?
I3CGLOBAL is one of the world's largest regulatory consulting firms, assisting small and medium-sized businesses all over the world.
Our knowledgeable advisors will analyze your Technical File, register your medical device or IVD, and reply to any queries or issues raised by the Competent Authorities.
We take great care in managing and maintaining your technical documents. Our extensive knowledge of European legislation, gained through the registration of hundreds of devices, ensures a simple and quick registration procedure.
We give out periodic updates to all of our Authorized Representation clients on key regulatory developments in Europe.The Regulations on Medical Devices (Regulation (EU) 2017/745) and In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) altered the European legal framework for medical devices, introducing new responsibilities for the EMA and national competent authorities in the evaluation of certain categories of medical device.
Contact I3CGLOBAL
I3CGLOBAL will assist with all reporting, registration, and contact with European authorities and organizations to the right person at the right time, every time. The European Authorized Representative must also keep a copy of the manufacturer's Declaration of Conformity and Technical File, as well as a record of product complaints in Europe, according to the Regulations.
- Germany+ 49 2161 990 8831
- Bangalore +91 99 4591 2081
- Mail to: enquiry@i3cglobal.com
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