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.


  • Defining scope
  • Drawing up the written mandate
  • Reviewing technical documentation
  • Feedback on the technical documentation
  • Post-market support

Your contact

Verena Wieser, Medical device consultant at Lorit

Verena Wieser

Medical Device Consultant


Companies around the world rely on our extensive knowledge in safety-relevant industries when developing their products.

Lorit Consultancy guided us through the intricacies of security regulations for medical devices in no time. We received concrete and comprehensive answers to questions we had been unable to find answers to for some time. Now, we can go to the market faster.

Natalia Kazankova – Senior Product Marketing Manager, Code Intelligence

As a leading medical device manufacturer, we greatly benefited from Lorit Consultancy`s services. The training always has effective combination of theory with practical insights, what is essential for our medical device development/manufacturing. The trainers were exceptional, simplifying complex concepts and engaging us with interactive discussion and case studies. Training has enhanced our teams capability of ensuring our products meet the highest standards.

We sincerely appreciate the professionalism and expertise of the Lorit Consultancy team. Their commitment to excellence has profoundly impacted our work. Thank you for an outstanding training experience.

Vladislavs Pavlovs – Laser and Electronic Components Development Department, CeramOptec GmbH

In summary; very useful, the recommendations/observations are recognisable and the report will help steer future 62304 compliance efforts.

In addition, the report also satisfied our external stakeholders.

Phil Cooley – Quality Manager, Bond Digital Health Ltd


Thank you, for a terrific course!
The trainer was extremely knowledgeable about the material, and made the content very easily digestible, even the more challenging bits.  I am very satisfied.

Rhyse Jaeschke – Manager, System Verification & Validation Ultrasound R&D, Philips Healthtech


With Lorit Consultancy we have found an extremely reliable partner who sees the big picture. Through their Functional Safety Engineering (ISO 26262) competence, we enjoy support at the highest level within our automotive product development.

Remarkable is the smooth integration into our internal development team and the always professional & uncomplicated communication. We look forward to many more joint projects!

Harald Sporer – Senior Project Manager, Automotive Sense & Control, Infineon

It was really a very helpful and excellent training!

Marco Augustin – Quality and Software Manager, Occyo


Lorit Consultancy´s support was instrumental in helping us achieve compliance in IEC-62304/ 82304 and ISO 14971 for our software-as-a-medical-device product.

Ju Zhang – Founder, CEO Formus Labs


Plexus has used the services of Lorit Consultancy in relation to a new healthcare project where insights into ISO 14971 and IEC 60601-1 international standards was needed.  We have been very impressed with the quality of knowledge within Lorit and the quality of documentation and deliverable, and we look forward to continuing to partner with Lorit in the future.

John Simpson – Senior Manager, Engineering  Plexus

Essential for my job. Reduced my fear of 60601.

Senior Mechanical Engineer

Lorit Consultancy gave us excellent support in defining the requirements and implementing the BS EN 62304 document structure for our first product.

Selly Saini – CEO  Inside Biometrics

It’s great to have the opportunity to receive this training from somebody who is obviously an expert in the topic and understands the practical implementation.

Senior Design Assurance Engineer

Lorit Consultancy provided a professional and efficient service in defining regulatory requirements for both new developments and legacy products.

Alastair Mutch – VP Research and Development, Diagnostics Cardiology Spacelabs Healthcare

Excellent course and very pragmatic approach on implementing compliance.

Senior Software Engineer

Lorit Consultancy gave us great support when guiding us through the process of hardware metric generation as defined in ISO 26262.  Providing both the FMEDAs and training on the use of them.

Geoff Owen Protean

Very well executed, very helpful. Thank you for your time and expertise.

Senior Electronics Engineer


The instructor was extremely engaging and clearly had excellent knowledge of the material.

Innovation Agent