Registration has two parts and both involve uploading information to modules of the EUDAMED database. The obligations to register can be found in Articles 29 and Article 31. Article 31 requires economic operators (Manufacturers, Authorised Representatives and Importers) to register to obtain a Single Registration Number or “SRN”. Article 29 requires manufacturers to upload information about each device, including its UDI information.

In the first step of the registration process, the Manufacturer, Authorised Representative or Importer submits the so called economic operator information (US: establishment registration) as defined in Annex VI Part A Section 1. Once this information has been validated by the corresponding national competent authority, the Manufacturer, Authorised Representative or Importer is issued with a SRN.

Having received the SRN, the Manufacturer, Authorised Representative, or Importer is able to proceed with the second step and submit the information related to the device (US: device listing) as defined in Annex VI Part A Section 2, as well as the UDI data defined in Annex VI Part B.

The SRN is also necessary for other purposes, not only for registration of the device: With the SRN, the Manufacturer is able to prepare the EU Declaration of Conformity for the device as described in Annex IV.  If the device classification requires a Notified Body to be involved in the conformity assessment (see step 8), the SRN also enables the Manufacturer to submit the application to the Notified Body.

If the device doesn’t require the involvement of a Notified Body in the conformity assessment, all the steps necessary to begin marketing the device have now been completed. Manufacturers of certain class I devices can bypass Step 8 and go directly to Step 9. On condition of course they have complied with all the earlier steps and their Class I device is not sterile, not reusable and does not have a measuring function (See Article 52, 7.).

Deliverables for demonstrating compliance:

(1) The Single Registration Number,

(2) The UDI data uploaded to EUDAMED,

(3) The EU Declaration of Conformity.

14 thoughts on “Step 7. Register the device and the manufacturer”

  1. We are the authorised representative for a number of non-EU manufacturers of medical devices. We wish to register with EU MED and obtain our SRN. Please send me a link the appropriate web site that allows us to do this.

    1. Thank you for your question.

      In October 2019 the European Commission concluded it will only be possible to make EUDAMED operational in May 2022. Until EUDAMED is available, economic operators must continue to register with their national competent authority according to the existing national processes that were established under the medical device Directives.

    1. Thank you for your question about obtaining the Single Registration Number (SRN).

      According to the “Joint Implementation/preparedness plan” published in March 2020 “…an MDCG position paper is under preparation with the aim of explaining the issuing of Single Registration Numbers (SRNs)…”. In the meantime, if your company is ready to register according to Article 31, you should consult your national competent authority or the national competent authority of your authorised representative.

  2. Hi,
    As the EUDAMED will be functional by May 2022, so far class 1 non-sterile devices that only requires self declaration, do we just issue EC Declaration by using UDI (GTIN numbers) or we need to register with EUDAMED as it is non-functional yet.

    1. Thank you for your question about registration.

      It has been possible to register EU MDR class I devices, those which do not require a conformity assessment procedure, since the entry into force of the regulation in 2017. That is not changed by the delay in the availability of EUDAMED. Please consult your national Competent Authority (or the Competent Authority of your Authorised Representative) for details of their national registration procedure for EU MDR compliant devices.

  3. Since EUDAMED will not be live on the date of application of the MDR, what information must be “registered” by the DoA?

    1. Thank you for your question.

      Until the registration module of EUDAMED is available, manufacturers must continue to register themselves and their devices (both MDD and MDR devices) with their national competent authority, or with the national competent authority of their authorised representative. The information required varies currently from country to country, depending on the national database.

  4. We are non EU manufacturer of medical device. how we can register for SRN or obtain SRN?
    is it compulsory to obtain SRN?
    As we have all our devices registered under MDD.

    1. Thank you for your question about registration.

      Until EUDAMED is made available, registrations of devices and manufacturers according to the EU MDR will be submitted to the national Competent Authorities, as it was under the Directives. Where previously your Authorised Representative registered your company details and your MDD compliant devices with his local Competent Authority, according to the MDD requirements. Now your Authorised Representative will also register your company details and your EU MDR compliant devices, according to the EU MDR requirements.

  5. Hi
    If the economic operator needs to register their device and obatin a SRN. I have an question. If you are making a device outside Europe the following actors need to register the device. Outside manufacturer, European Authorised Representative and the importer. Doe this mean there will be 3 seperate “The single registration number” ? Or does the device obtain 1 number?
    Thank you so much.

    1. Thank you for your question.

      The registration of a device is different to the registration of the economic operators responsible for that device. The SRN is for economic operators. Devices have the UDI.

    1. Thank you for your question about the Single Registration Number.

      The SRN is issued to the manufacturer, the authorised representative or the importer as a consequence of registering (Article 31,2). The notified body is not involved.

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