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 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.
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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, or European Authorized Representative, is a legal entity established within the European Union that acts on behalf of a non-EU manufacturer to ensure that their medical devices and in vitro diagnostic devices (IVDs) comply with EU regulations.
A CH-REP, or Swiss Authorized Representative, is a legal entity established within Switzerland that acts on behalf of a non-Swiss manufacturer to ensure that their medical devices and IVDs comply with Swiss regulations. The role of the CH-REP is similar to that of the EC-REP but is specific to the Swiss market.
A UK-RP, or UK Responsible Person, is a legal entity established within the United Kingdom that acts on behalf of a non-UK manufacturer to ensure that their medical devices and IVDs comply with UK regulations.
The terms EC-REP, CH-REP, and UK-RP refer to different types of authorized representatives required for medical devices and in vitro diagnostic devices (IVDs) in the European Union (EU), Switzerland, and the United Kingdom (UK), respectively. Each of these representatives plays a crucial role in ensuring that manufacturers comply with the regulatory requirements of their respective markets.
- EC-REP (European Authorized Representative)
An EC-REP, or European Authorized Representative, is a legal entity established within the European Union that acts on behalf of a non-EU manufacturer to ensure that their medical devices and IVDs comply with EU regulations. - CH-REP (Swiss Authorized Representative)
A CH-REP, or Swiss Authorized Representative, is a legal entity established within Switzerland that acts on behalf of a non-Swiss manufacturer to ensure that their medical devices and IVDs comply with Swiss regulations. The role of the CH-REP is similar to that of the EC-REP but is specific to the Swiss market. - UK-RP (UK Responsible Person)
A UK-RP, or UK Responsible Person, is a legal entity established within the United Kingdom that acts on behalf of a non-UK manufacturer to ensure that their medical devices and IVDs comply with UK regulations.
In summary, while the roles of EC-REP, CH-REP, and UK-RP are similar in terms of ensuring regulatory compliance and acting as a liaison between manufacturers and regulatory authorities, they are specific to their respective regions and regulatory frameworks. Manufacturers must appoint the appropriate representative based on the market they wish to enter.
The primary role of an Authorized Representative 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, CH or GB needs to appoint an Authorized Representative. Manufacturers with physical presence in the EFTA countries do not need a EC-REP.
Yes, a manufacturer can change their Authorized Representative by providing timely notification to the new and current Authorized Representative, ensuring a smooth transition without losing compliance.
No, cosmetic products do not require an EC REP. They fall under different regulatory requirements within the EU. However, a Responsible Person (RP) is required for cosmetics to ensure compliance with safety and regulatory standards.
Post-Brexit, the UK is no longer part of the EU. Therefore, separate regulatory compliance and representation may be required for the UK market, distinct from EU requirements. Specifically, a UK Responsible Person (UK RP) is needed for cosmetics to ensure compliance with UK regulations.
The Authorized Representative acts as the liaison between the manufacturer and EU national competent authorities, managing reports and communications regarding compliance and vigilance.
Yes, the EC-REP (European Authorized Representative) must be included on the device label. This requirement is part of the regulatory framework established by the European Union to ensure that medical devices and in vitro diagnostic devices (IVDs) comply with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The inclusion of the EC-REP on the device label provides a clear point of contact within the EU for regulatory authorities, healthcare professionals, and users in case of any issues or questions regarding the device.
The device label must include the following information about the EC-REP:
- Name and Address: The full name and address of the EC-REP.
- EC-REP Symbol: The official EC-REP symbol should be displayed next to the name and address to indicate the role of the representative.
Language Requirements:
- The information must be provided in a language that is easily understood by the end-users and regulatory authorities in the EU member states where the device is marketed.