Certificates of Free Sale intended for CE marked Medical Devices

About Clinical Research Organizations:

A clinical research organization (CRO) also called as a, contract research organization. It’s a service organization which provides support to biotechnology, generic drug, OTC/consumer healthcare and medical device, pharmaceutical industries.

Clinical Research Organizations provide clients by means of different research services to give support to in both drug and medical device, research and development process, as well as product development, manufacturing and formulation; medical, clinical and safety monitoring; toxicology, preclinical and clinical laboratory, clinical trial management services in support of processing test samples; biostatistics ,data management and bio-medical writing services, mainly in grounding for FDA ,New Drug Application (NDA).

The role of an European Authorized Representative

• Registers all the devices to national Competent Authorities prior to the marketed, wherever valid.
• Acts as the main contact point to all the national Competent Authorities.
• Maintains a present copy of Technical File that is available for assessment by the EU Competent Authorities.
• Give permission to place address and name on the device packaging, label and Instructions to be Use.
• A European Authorized Representative is all the time available to cooperate with product owner and with national Competent Authorities.
• Responsible for event exposure to Competent Authorities, all together with owner and distributors.
• Protects the privacy of the credentials. The EA Representative only demonstrates technical credentials to Competent Authorities as mandatory by law.
• Notify or is informed by Competent Authority of somber device incidents.