Services
EC-REP Service
In our role as your Authorized Representative, we guarantee the sustained compliance of your product over its entire life cycle. This encompasses managing regulatory inquiries, implementing measures to mitigate product risks, furnishing the necessary data to substantiate product compliance, and overseeing the handling of complaints, reports, and potential instances of non-compliance.
European Union
For medical devices and in vitro diagnostic devices, the EU Regulations (MDR and IVDR) require that non-EU manufacturers appoint an EU-based authorized representative who plays a pivotal role in the compliance of their devices and acts as a contact point in the EU.
Providing representative and consultancy services, we help manufacturers who want to enter the EU market. With our EU headquarters in Germany, we are based in the geographic heart of the Union and in one of the strongest and most data-protective countries of the EU. In this way, we have shaped the compliance industry over the years and guarantee our customers the highest level of confidentiality.
Great Britain
Since Brexit in 2020, non-UK manufacturers must appoint a UK-based Responsible Person (UK RP) for medical devices and IVDs.
MedNet EC-REP's team in Great Britain provides professional representation and consultancy services to help you place your product on the British market. Thanks to our experience, as well as our comprehensive knowledge and understanding of the requirements, we help manufacturers enter the British market quickly and in compliance with UK regulations.
Furthermore, we regularly provide our customers with the latest updates on regulatory changes.
Switzerland
Switzerland and the European Union have not renewed the agreement on the mutual recognition of medical devices. This affects the placing of Medical Devices and In Vitro Diagnostic devices, under the regulations MDR and IVDR.
In order to distribute Medical Devices and In Vitro Diagnostics in Switzerland, non-Swiss manufacturers must appoint a Swiss-based Authorized Representative, the CH-REP.
Our team of experts at MedNet EC-REP can assist you in complying with Swiss regulations.
Get a Quote
Our cross-cultural team of scientists and engineers is well equipped to understand your needs and the requirements your are going to face by bringing your device on the European, British or Swiss market.
Let us know your requirements and we will be at your service.
Frequently asked Questions
An EC-REP (European Authorized Representative) is an entity appointed by non-European manufacturers to act as their legal representative within the European Union (EU).
The primary role of an EC-REP is to serve as the point of contact between the manufacturer and the European regulatory authorities. They assist the manufacturer in meeting their obligations under the EU Medical Device Regulation (MDR) or the In-Vitro Diagnostic Regulation (IVDR). This includes tasks such as registering devices, keep copy of the technical documentation, and handling communication with authorities.
Any manufacturer of medical devices or in-vitro diagnostic devices that does not have a physical presence within the EU needs to appoint an EC-REP. This includes manufacturers based in countries such as the United States, Australia, China, Taiwan, Malaysia, Israel, India or Japan. Manufacturers with physical presence in the EFTA countries do not need a EC-REP.