In-country representation for Medical Device and IVD Manufacturers

For manufacturers

We represent you in the EU, UK, and US, so you can launch faster.

We handle registration, documentation, and compliance obligations across regions, so you can focus on getting your device to market.

For users, importers, distributors

Have an issue with a medical device? We’re the official contact.

As designated regulatory representatives, we manage product complaints, safety reports, and user inquiries across all key regions.

EU Authorised Representative

EU regulations require medical device and IVD manufacturers based outside the European Union to appoint an EU Authorised Representative (EU REP) located within Europe before placing products on the market.

Your EU Authorized Representative acts as your official contact with EU Competent Authorities — government bodies in European countries responsible for ensuring that medical devices are safe and comply with EU regulations.

The role of EU REP includes:

• Making sure your medical devices meet EU regulatory requirements before they are placed on the market
• Reviewing and storing your technical documentation, certificates, and EU Declaration of Conformity, and keeping them readily available for inspection by Competent Authorities
• Ensuring your devices are correctly registered in the European Database on Medical Devices (EUDAMED) and comply with Unique Device Identification (UDI) obligations
• If requested, supplying the necessary documentation to Competent Authorities in the required official EU language
• Coordinating requests from Competent Authorities for product samples or access to your devices
• Collaborating with Competent Authorities to address safety-related issues or field safety corrective actions (FSCAs), aiming to minimize risks to patients
• Promptly notifying you about any complaints or incident reports received from users, patients, or healthcare professionals

EU Importer of software medical devices

EU regulations (MDR 2017/745 and IVDR 2017/746) require that non-EU manufacturers designate an EU Importer for any medical or in vitro diagnostic devices they intend to place on the EU market.

Star specializes in the import of software-based medical devices. As your EU Importer, we help ensure that your products are safely introduced into the European market.

The EU Importer is typically responsible for:

• Verifying that the device bears a valid CE marking and is accompanied by the required documentation
• Confirming that the manufacturer has appointed an authorized representative within the EU
• Verifying whether a Unique Device Identification (UDI) has been assigned and that the device has been correctly registered in the European Database on Medical Devices (EUDAMED)
• Ensuring that the importer’s details are clearly indicated on the device, its packaging, or accompanying documentation
• Maintaining appropriate storage and transport conditions while the device is under the importer’s control
• Record and track complaints, non-conforming devices, recalls, and withdrawals, and report any such issues to the manufacturer and their authorized representative
• Collaborating with the manufacturer, their authorized representative, and EU Competent Authorities to ensure appropriate corrective actions are implemented—such as bringing a non-conforming device into compliance, withdrawing it from the market, or initiating a recall
• Informing the Competent Authorities of any device that presents a serious risk or is suspected to be falsified

US Agent

If you're a non-US manufacturer aiming to market medical devices in the United States, appointing a US Agent is a regulatory requirement. The US Agent must maintain a physical place of business in the US.

The responsibilities of the US Agent include:

• Assisting the FDA in communications with your company
• Responding to questions concerning your devices imported into the US
• Assisting the FDA in scheduling inspections of your company
• If the FDA is unable to contact your company directly or expeditiously, the FDA may provide information or documents to the US Agent, and such action shall be considered equivalent to providing the same information or documents to your company

There's no need to establish your own office in the US — Star is ready to act as your trusted US Agent, ensuring full compliance with FDA requirements.

US FDA Official Correspondent

All companies selling medical devices in the US are required to appoint an Official Correspondent at the time of Establishment Registration. For foreign companies, a US Agent must also be appointed, in addition to the Official Correspondent. While the Official Correspondent does not need to be located in the US, the US Agent must have a physical place of business in the country.

The responsibilities of the Official Correspondent include:

• Annual establishment registration with the FDA
• Contact with the FDA for device listing
• Maintenance and submission of a current list of officers and directors to the FDA
• Receipt of pertinent correspondence from the FDA, directed to and involving the owner or operator and/or any of the firm's establishments

Star can serve as both your Official Correspondent and US Agent. By appointing us, all FDA inquiries and facility inspection notifications will be directed to Star, ensuring streamlined and efficient communication.

UK Responsible Person

If you're a non-UK manufacturer planning to market medical devices or IVDs in Great Britain (England, Scotland, and Wales), UK Medical Devices Regulations 2002 (UK MDR 2002) requires you to appoint a UK Responsible Person (UKRP).

The UKRP must be established in the UK and acts on your behalf to ensure compliance with local regulations.

The responsibilities of the UK Responsible Person include:

• Registering your devices with the Medicines and Healthcare products Regulatory Agency (MHRA) - an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medical devices work and are acceptably safe
• Ensuring the availability of technical documentation and Declaration of Conformity
• Cooperating with the MHRA on corrective or preventive actions
• Notifying you immediately of complaints or suspected incidents involving your devices

There’s no need to set up a UK office—Star already has a UK presence and can serve as your UK Responsible Person, helping you access the market smoothly.

UK Importer of software medical devices

At Star, we support non-UK manufacturers of software-based medical devices and IVD in bringing their products to the Great Britain market in full compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002).

UK Importer responsibilities is typically include:

• Importers must inform the UK Responsible Person (UKRP) of their intention to import medical devices. The UKRP is then responsible for submitting the importer’s details to the MHRA as part of the device registration process
• Importers must confirm that devices carry a valid UKCA or CE marking (depending on the applicable route to market) and meet the relevant conformity requirements
• Importers are responsible for maintaining appropriate storage and transport conditions while the devices are under their control
• Unlike EU regulations, UK law does not require the importer’s name and address to appear on the device label—unless the importer or distributor is also acting as the UKRP for the purposes of UKCA marking