EU Regulations on Medical Devices and IVD medical devices: What is the mandate and when do manufacturers need it?

Non-EU manufacturers can sell medical devices on the European Union market only if they appoint an authorised representative (EAR). An EAR is appointed through a mandate, a document signed between the EAR and the manufacturer. This is the official designation of EAR for listed devices and allows manufacturers to place these medical devices on the EU market legally.

Mandate under the new Regulations (MDR and IVDR)

EU MDR and IVDR specify in Article 11 minimum requirements that a mandate should contain, and it includes the tasks of the EAR towards the manufacturer, the authorities, and the supply chain.

Only devices that are covered by a valid mandate can be placed on the EU market.

This includes devices that are subject to the legacy status, as manufacturers must sign a mandate due to new, legacy requirements under the MDR and IVDR. This means that even if a manufacturer has a CE Certificate issued under the Directives that is still valid and meets the legacy requirements, they must undergo an MDR review under Article 120 or IVDR review under Article 110 (legacy review by their authorised representative) and sign a mandate.

What does the mandate include?

The MDR and IVDR outline the key role that the authorised representative has in verifying compliance of the manufacturer. The mandate has to include at least the following tasks performed by the authorised representative:

  • Verification that technical documentation and other essential documents have been drawn-up and keeping these documents available to competent authorities.
  • Verification that an appropriate conformity assessment procedure has been carried.
  • Providing competent authorities with all the information and documentation necessary to demonstrate the conformity of a device and collaborating with them.
  • Informing the manufacturer any request of the competent authorities as well as of any complaints and reports from healthcare professionals, patients, and users.

The mandate must also indicate the device groups, covering all devices from the device groups listed.

Mandate with an EAR for MDR notified body application

Following the transitional provisions’ extensions, non-EU manufacturers with a valid CE Certificate can enjoy a longer legacy status and keep placing their devices on the market after the CE Certificate expiry date. Nonetheless, one of the requirements to be eligible for the extension is having submitted an application with a notified body by May 2024. For the MDR application, notified bodies usually ask for a mandate or proof that there is already an agreement in place between the authorised representative and the manufacturer. However, signing only a service agreement, which sets out contractual arrangements with an authorised representative does not mean that the manufacturer has a mandate in place, and it is not generally sufficient for the MDR application. An EAR service agreement is a contract between the authorised representative and the manufacturer that outlines the services provided by the authorised representative. The mandate, on the other hand, states that the obligations of the EAR and the manufacturer have been fulfilled.

If the authorised representative cannot sign the mandate due to a reason of non-compliance on the side of the manufacturer, the authorised representative can issue a ‘’Letter of intent’’ to become an EAR in case manufacturer complies with MDR or IVDR, which will assist in communication with the notified body.

Obelis has 35 years of experience in EU regulatory affairs for medical devices. Over the decades, our team of professionals helped thousands of manufacturers to achieve compliance and smoothly enter the EU market. If you appoint Obelis as your Authorised Representative, we will be your regulatory partner and support your business in Europe, taking care of all obstacles you might face. Don’t let regulatory challenges hold your business back!

Simona Varrella

Publications department


The information contained on is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.

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