EC Authorized Representative
EC Authorized Representative Consultancy & Support
Lorit Consultancy is your trusted EC Authorized Representative for medical device manufacturers outside the European Union. Manufacturers entrust us to act as their liaison, ensuring seamless compliance with EU regulations.
With our expertise in both – representation and safe product design – we support the legal responsibility for the conformity and safety of medical devices.
Responsibilities of an AR
As an EC Authorized Representative (AR) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), we meticulously verify technical documentation and ensure the declaration of conformity is drafted in adherence with EU standards.
EC Rep acts as a vital conduit between manufacturers and EU authorities, facilitating seamless communication. Furthermore, our commitment extends to post-market activities including orderly reporting to manufacturer and assistance in any necessary follow-ups or actions required after the medical device has been placed on the market.
What we can do for you
We draw upon our extensive expertise in medical device registration to offer invaluable insights and best practice examples. Lorit Team provides comprehensive support for EUDAMED registration and, being located in Austria, can assist with registration in the Austrian Medical Device Register (MPR), a prerequisite for EUDAMED.
As a safety compliance consultancy we can support you in drafting technical documentation using first-hand knowledge and experience.
Our services
Consultancy & Support:
Our workflow for the EC Authorized Representation services begins with an initial meeting to define the scope and mutual expectations.
Once agreed upon, we establish a written mandate where the manufacturer formally designates Lorit Consultancy as the authorized representative, outlining mutual obligations.
Next, we carefully review the technical documentation to ensure compliance with MDR or IVDR requirements, as well as relevant EU standards and guidance documents.
Throughout this process, we provide ongoing feedback and support, assisting you in implementing improvements and resolving any issues.
Following successful implementation, we continue to support you in maintaining compliance with EU regulations and provide assistance with post-market activities as needed.
Workflow:
- Defining scope
- Drawing up the written mandate
- Reviewing technical documentation
- Feedback on the technical documentation
- Post-market support
