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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.
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For medical devices and In-Vitro Diagnostic devices, the EU Regulations (MDR and IVDR) foresee that non-EU manufacturers must appoint an EU-based authorised representative that plays a pivotal role in compliance of their devices and acts as a contact point in the EU.
Providing representative and consultancy services we help manufacturers that want to enter the EU market. With our EU headquater in Germany we are in 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 an garantee our customers the highest level of confidentiality.
We recommend you to choose a professional representative as MedNet EC-Rep in the European Union.
You identify a professional representative by:
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 the comprehensive knowledge and understanding of the requirements we help manufacturers to enter the British market quickly and in compliance with the UK regulations.
Furthermore we regularly provide our customers with the latest updates of regulatory changes.
Switzerland and the European Union have not renewed the agreement on mutual recognition of medical devices.
This affects the placing of Medical Devices and In Vitro Diagnostic devices, under consideration of their 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.
