Tonom GmbH is a German based company focused on medical device authorized representation (EC REP), regulatory compliance, quality management and auditing for EU regulations.
We are focused on enhancing regulatory compliance in order to achieve sustainable outcomes and connecting innovation to business for safer and secure development, production and in-country representation of medical devices.
Our patio and expertise and proficiency as well as interest to science, innovation and a culture of operational excellence contribute to offer technology, services and support that improve the quality of people's lives.
We utilize years of hands-on experience and delight to introduce and represent in Europe the novel transpalpebral transscleral Tonometer Diaton
Our research and development team was created by scientists, technologists and specialists in the field of certification and quality management.
The purpose of the joint work is the design and implementation of innovative resource-saving solutions.
Sustainable Systems Research & Development Group
All non European manufacturers which does not have a physical location in Europe required to appoint an Authorized Representative (also referred to as an EU REP or AR) to represent the company to European authorities. The non European manufacturers must retain an EU REP as long as you sell your devices in Europe.
The European Authorized Representative act as a conjunction between the non EU manufacturer and the national Competent Authorities (Ministries of Health). The EU Rep hold the responsibility to act as a neutral party between the competent authorities and the non EU manufacturers.
Engaging and identifying of an EU REP is essential for non EU manufacturer. The Notified Body requires from the non EU manufacturer appointment of an EU REP prior they issue a CE certificate. Compliance with the applicable Directive is mandatory for any device placed in the EU market.
He must ensure the manufacturer’s compliance with the conformity assessment procedure set out in the European directives which are applicable to the manufacture’s product.
Main function of the EU REP:
EU REP assist with certain device registrations, as required
EU REP is identified on your product labeling throughout Europe
EU REP keep a current copy of your Technical File and CE Declaration of Conformity available for inspection by a Competent Authority, upon request
EU REP assist in cooperation with the manufacturer and local distributors with Incident and Field Safety Corrective Action (FSCA) reporting
Quality Assurance in order to solve complex regulatory challenges. The medical device regulatory landscape is complex. We will help to design a regulatory and QMS strategy conform to regulatory requirements as well as to create a quality manuals according to with the applicable regulations.
In-country representation and Device registration in order to maintain control of the device registrations as well as to get the products to market as efficiently as possible. We ssist to plan, compile, submit and to manage the device registrations.
Distributor Network building
A set distribution network does a lot to take a company to new heights. Direct sales are an expensive, time-consuming and risky way to introduce new products or services to the marketplace. We assist to establish a strong connection in the customer’s EU target market.
To compete for business and bring compliant products to market, the non EU manufacturer need not only to understand medical device regulatory requirements in their EU target markets but also to implement a Quality Management System, as required.
With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for tougher Post-Market Surveillance (PMS) requirements. We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.