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European Authorized Representative (EAR)

European Authorized Representative for Medical Devices

  2. Services
  3. CE Certification Consultancy
  4. European Authorized Representative (EAR)

What is a European Authorised Representative for Medical Devices?

Looking to sell your medical devices in Europe? Here’s what you need to know!

If your business is not based in Europe, you’ll need to appoint a European Authorised Representative for medical devices before you can sell your products there. This EU Representative for medical devices acts as your official point of contact with the authorities and helps make sure your medical devices meet all the necessary rules.

Having the right European Authorised Representative services makes a big difference. They help with the required documents, support you after your product is on the market, and stay up to date with any changes in the rules.

As a trusted medical device regulatory consultancy, Maven offers reliable EU Authorised Representative medical devices support. We make things easier for you by taking care of compliance, so you can focus on your products and growing your business.

What Does a European Authorised Representative Do?

  • Makes sure your medical devices follow the EU rules
  • Keeps your Technical Documentation up to date
  • Communicates with EU authorities on your behalf
  • Supports post-market surveillance and vigilance reporting.
  • Checks your product labelling and Declaration of Conformity

With Maven as your EU Representative for medical devices, you get complete regulatory support from a team that understands the industry. Let us handle the regulatory side—so you don’t have to.

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European Representative

As part of our European Authorised Representative services for medical devices, we take care of key responsibilities to support manufacturers:

  • We keep a copy of the technical documentation, ready to share with the relevant authorities if they ever ask for it during an inspection.
  • We check that the manufacturer has followed the device registration rules under the latest medical device regulations.
  • If any authority requests it, we provide all documents and details needed to show the device meets regulatory requirements, in the official language required by the respective authority.
  • We inform the manufacturer right away about any safety issues or complaints reported by users, patients, or healthcare professionals.
  • If the manufacturer breaks the rules under the regulations, the EU Representative for medical devices has the right to end the agreement.
  • Our EU Authorised Representative medical devices team includes at least one expert who meets all qualifications and experience needed under the regulations – known as the Person Responsible for Regulatory Compliance (PRRC)

As a trusted EU Representative medical device partner, our job is to make sure your products meet all legal requirements, giving you peace of mind and full regulatory support.

Changing Your European Authorised Representative for Medical Devices

If you’re planning to change your European Authorised Representative for medical devices, it’s important to handle the process carefully. A written agreement should clearly outline the roles and responsibilities of the outgoing and new EU Representative medical device.

This agreement should include:

  • The end date for the current EU Authorised Representative medical devices and the start date for the new one.
  • How long the old representative’s name can remain on labels, brochures, and other materials.
  • How documents and records will be safely shared, keeping all data secure and confidential.
  • What the outgoing representative still needs to do after the agreement ends, like passing on important updates.
  • How customer complaints or safety issues reported by users, patients, or professionals will be managed during the change.

To officially appoint a new European Authorised Representative, a signed agreement is required between the medical device manufacturer and the new representative. This agreement must follow the rules mentioned in EU MDR (Regulation (EU) 2017/745) or IVDR (Regulation (EU) 2017/746), depending on your device.

As a trusted provider of European Authorised Representative services, we help manufacturers ensure a smooth and fully compliant transition. Reach out to our expert team for end-to-end support.

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Changes After Brexit: What It Means for Your European Authorised Representative

Want to keep selling your medical devices in both the UK and the EU? After Brexit, the rules have changed for appointing authorised representatives.

If you’re a manufacturer outside the EU, you now need two separate authorised representatives—one in the UK and one in the EU. This is now required to continue placing your products in both markets.

For companies based in the UK selling medical devices in the EU, having a European Authorised Representative is now mandatory.

If you were using a UK-based representative earlier, you’ll need to switch to an EU Authorised Representative for medical devices to keep access to the EU market.

As a trusted medical device regulatory consultancy, we offer complete European Authorised Representative services to help you stay compliant and continue selling your products without interruption.

European Free Sales Certificate

Got your CE certificate and looking to expand your medical device sales globally? You might need a Free Sales Certificate to move forward with your distribution process.

This certificate is issued by the European Competent Authorities upon request from your European Authorised Representative. It’s an important document that allows you to freely sell or distribute your medical devices outside the EU.

Keep in mind, this certificate isn’t necessary for sales within the EU, as it only applies to markets outside the EU.

As a medical device regulatory consultancy, we offer a Free Sales Certificate through our European Authorised Representative to ensure your devices are ready for global distribution.

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To get a Free Sales Certificate for your medical device, here's what you'll need:

  • Meet the Required EU Standards: This includes providing proof like the CE Certificate, Technical File, and EU Declaration of Conformity.
  • Appointed EU Representative Details: You’ll need to show the agreement with your European Authorised Representative (EU REP) for your medical device.
  • Registration Information: Provide the registration details of your company.
  • Quality Certifications: Ensure you have quality certifications like ISO 13485 or ISO 9001 as proof of your device’s quality.

As a medical device regulatory consultancy, we can assist you with all the necessary steps and ensure that you meet the EU requirements, helping you navigate the process with ease.

When looking to legalise a Free Sales Certificate, there are a few institutions you can approach:

  • The Chamber of Commerce
  • The Ministry of Foreign Affairs
  • The Relevant Embassy

We help you get both, legalised and non-legalised Free Sales Certificate. It’s important to note that the Free Sales Certificate must also include the Basic UDI-DI of the device, as per the UDI requirements outlined in the EU MDR Regulation 2017/745.

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Frequently Asked Questions

Yes, if your company is based outside the European Union, you must appoint an EU Authorised Representative to legally sell medical devices in the EU. The representative ensures your products meet EU MDR or IVDR requirements, acts as a liaison with EU authorities, and maintains key regulatory documents. Without an authorised representative, your device cannot be placed on the EU market.

To become an EU Authorized Representative for medical devices, you must be a legal entity established within the European Union and have the necessary regulatory expertise. You need to sign a formal agreement with the non-EU manufacturer, outlining your responsibilities as per Article 11 of Regulation (EU) 2017/745 or 2017/746. Additionally, your organization must appoint a qualified Person Responsible for Regulatory Compliance (PRRC) and be capable of maintaining technical documentation, handling regulatory communication, and supporting post-market activities.

The cost of appointing an EU Authorised Representative can vary based on the services offered, product type, and regulatory complexity. Typically, the annual fee ranges from 1200 to 3000 Euros annually. This may increase if additional support is required, such as handling multiple devices, urgent documentation reviews, or acting as PRRC. Always ensure the representative is experienced and compliant with EU MDR/IVDR requirements.

An EU Authorized Representative (EAR) acts on behalf of a non-EU medical device manufacturer to ensure compliance with EU MDR or IVDR. Their key responsibilities include maintaining up-to-date technical documentation, verifying device registration, acting as the contact point for EU authorities, assisting in post-market surveillance, and ensuring correct labeling and Declaration of Conformity. They must also have a qualified Person Responsible for Regulatory Compliance (PRRC) and support incident reporting. They are responsible for verifying manufacturer and product registration on EUDAMED.

Watch Our Video for a Quick Overview

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