Benefits of Appointing an EU AR.
Med-Di-Dia Limited
Regulatory Risk Partner for #MedicalDevices #Diagnostics and #DigitalHealth in European Union
The European Union (EU) Medical Devices Regulation (MDR) requires all medical device manufacturers to appoint an?EU Authorised Representative (EUAR)?if they are not established within the EU. The EUAR is responsible for ensuring compliance with the MDR on behalf of the manufacturer. You are NOT compliant with regulatory requirements if you do not have an EU AR or a European Entity.
Appointing an EU AR will provide you with the following benefits:
One of the primary benefits of appointing an EU AR is compliance with EU regulatory requirements. Non-EU manufacturers are required to comply with EU regulations when selling medical devices in the EU, and an EU AR can help ensure that the device meets these requirements. The EU AR is responsible for ensuring that the medical device complies with the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR) and maintaining compliance throughout the device's lifecycle.
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Appointing an EU AR can also help non-EU manufacturers bring their medical devices to market more quickly. The EU AR is familiar with the EU regulatory landscape and can help non-EU manufacturers navigate the complex regulatory requirements. This can help reduce the time and resources required to bring a medical device to market in the EU.
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An?EU AR?has the expertise and local knowledge of the EU regulatory environment. They can provide valuable insights into the EU's regulatory requirements, market trends, and customer needs. This knowledge can help non-EU manufacturers develop and launch products that meet the needs of the EU market.
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Appointing an EU AR can also help non-EU manufacturers save costs. The EU AR can handle the regulatory compliance responsibilities, which can be time-consuming and costly for non-EU manufacturers to manage independently. The EU AR can also help non-EU manufacturers avoid expensive mistakes and penalties associated with non-compliance.
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Finally, appointing an EU AR is essential for non-EU manufacturers who want to access the EU market. The?EU AR?is responsible for registering the medical device with the appropriate regulatory authorities in the EU, and without an EU AR, non-EU manufacturers cannot legally sell their medical devices in the EU market.
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Our experts provide all of these supports and protection from the EU Regulatory requirements.
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