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.
Guidance
Guidance is also available from the Medical Device Coordination Group;
on the European Medical Device Nomenclature (EMDN)
- MDCG 2024-2 Procedures for the updates of the EMDN.
- MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN).
- EMDN The EMDN – The nomenclature of use in EUDAMED.
- CND The CND nomenclature – Background and general principles.
- MDCG 2018-2 Future EU medical device nomenclature - Description of requirements.
and on EUDAMED
- MDCG 2021-13 Rev. 1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR.
- MDCG 2021-1 Rev. 1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
- MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
- MDCG 2019-5 Registration of legacy devices in EUDAMED
- MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
The European Commission has also established several web-pages dedicated to EMDN and EUDAMED, including a help desk.
Click this link to go to the EUDAMED database.
CLick this link to view and search the EMDN.
Hello, if I have MDR registration certificate in Poland does it allow me to sell freely f.e. in Netherlands or do I have to go through registration and certification process again? How does it work?
I do not recognise the term “registration certificate”.
There are exceptions, but in terms of certificates, most manufacturers will have two, issued by a European Notified Body; a Quality Management System certificate related to the company, and a Conformity certificate related to the device in question. But if your company has those, and your company and the device in question are registered in EUDAMED; if the labelling of the device fulfils the language requirements in the member state you want to supply, then any of the countries in the EEA are a so called “single market” for your device. Meaning, your certificates are recognised and your device is accepted throughout the European community.
Hi,
I am an economic operator in Romania, importer and distributor of products under my own label.
I do not manufacture and I hold an importer ID/SRN eudamed.
I plan to start selling, under my own a label, in Romania, a class I MDR medical device, manufactured in Turkey. What are my responsibilities under MDR to be able to place the product on the market?
Thank you,
Raul
It depends what is meant by “under my own a label”.
The name and address of the legally responsible manufacturer must be printed on the label and in the instructions. If that is the name and address of the company in Turkey; as no authorised representative is required (according to the EU-Turkey Customs Union agreement), then you are most likely acting as a distributor and the general obligations of distributors in Article 14 apply to you. If however, the manufacturer’s name and address is not present (which is anyway a non-conformity) but only your company’s branding, then your company will be considered the manufacturer.
Is the manufacturer of medical device (MD) obliged to issue product liability during clinical investigation when he is not yet selling the MD under investigation and MD is not yet CE-certified?
As described in Article 69 (Damage compensation), both the sponsor of the investigation and the investigator are required to have such insurance.
From which date is it mandatory to register in EUDAMED and get a SRN number for class 1 devices?
At the time of replying to your your question, three modules are available for voluntary use (actor registration; UDI and device registration; notified bodies and certificates). While originally it was planned that these modules should only become mandatory when all the other modules were available, it has since been proposed to make these modules mandatory at an earlier date.
It is best to refer to the Commission’s EUDAMED page for the latest information on module availability and mandatory dates.
https://health.ec.europa.eu/medical-devices-eudamed/overview_en
Does the EUDAMED device registration eliminate the need to register devices with the national competent authority? eg: If my devices are CE marked under MDR and are registered on EUDAMED, can I distribute to any EU country without any national registration?
Yes. Once the manufacturer has registered as an “economic operator” and the device’s details are also registered in EUDAMED, the device can be distributed throughout the Union market.
Some individual European countries may operate national registration or certification schemes for distributors of medical devices in their country, but compliance with those purely national requirements is the responsibility of the distributors operating in that country.
Hi,
Is it necessary to mention the SRN of importer’s at the LABEL behind the Consignee address…?
The information required on the label is specified in Annex I 23.2. The importer is not mentioned. Perhaps you are referring to the Importer’s obligation in Article 13 3. There is no mention of the SRN in this obligation.
If we have not registered for an actor module yet. can we sign off our technical file for class I self-certified device without the SRN number and update it later once we have registered?
With respect, signing off the technical file is an internal procedure not specified in the EU MDR. Therefore, you are free to do whatever your quality system allows.
If a Declaration of Conformity is revised, how does that get updated in EUDAMED?
The EU Declaration is not uploaded to EUDAMED. It is retained by the manufacturer and, if applicable, the authorised representative and importer, to be made available on request.
Hi,
Shall devices, needing a notified body, be registered in EUDAMED before or after the notified body certificate is received?
After receiving the certificate. As the information which has to be submitted to EUDAMED about the device includes the number and expiry date of the certificate.
We are non EU manufacturer of class IIa, Iib Medical Device. Do I need to apply for UDI-ID and SRN. We are preparing to MDR certificate.
Until all the six planned EUDAMED modules are finalised, you should check with your Authorised Representative whether their Competent Authority requires Manufacturers to use the already available EUDAMED modules or an alternative (national) registration procedure.
We are non EU manufacturer of Class 1 Medical Device. Do i need to apply for UDI-ID and SRN. We work as OEM Supplier for EU Buyer and using there Brand Name on only there Order Supplies. Still we have to apply for UDI-ID and SRN Numbers?
This is a commercial matter not a question about the EU MDR. It would be preferable if this topic was addressed in the contract between the two companies. But if not, the two companies must agree which company will be the manufacturer according to the EU MDR; i.e. named as manufacturer on the labels and instructions, on the Declaration of Conformity, registered in EUDAMED etc.
Will Class I reusable Self-Certified devices under MDD (now designated as Class Ir under MDR) be registered as Legacy devices of MDR devices in EUDAMED?
It depends on the Declaration of Conformity. If you are placing devices on the EU market with a Declaration of Conformity which claims they conform to the MDD, they are legacy MDD devices and must be registered in EUDAMED as such. If you are placing devices on the EU market with a Declaration of Conformity which claims they conform to the EU MDR, they are not legacy devices.
We are manufacturer of Class I device based in EU. Our device continues to comply with Directive 93/42/EEC and is covered by the transitional provision in Article 120 of the 2017/745.
Our device is not sterile and not with a measuring function under the Directives , hence it does not require a certificate issued by a Notified Body.
We already have SRN for our organization but EUDAMED “Register a legacy device module” under the UDI-DI/ Device section does not allow us to register our device without certification information from NB.
Please guide us how we register our Class I device to EUDAMED without an NB certificate.
You should refer to the page dedicated to the EUDAMED registration module at; https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
Including; MDCG 2019-5 on legacy device registration in EUDAMED. https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_5_legacy_devices_registration_eudamed_en.pdf
Hello,
I have a question for you, please. We are manufacturers of class III medical devices and next year we want to start the transition from MDD to MDR. For a medical device, EC Certificate expires in February 2023.
We are already preparing the documentation according to the new Regulation for every medical device.
How long before we must announce NB?
Thank you so much for your time!
Each notified body has different resources and therefore different capacities and timelines; but the general advice of all notified bodies is that manufacturers discuss their transition plans with their notified body at the earliest opportunity.
When will it be possible to register Class 1 devices on Eudamed please?
The module for Actor registrations, for Manufacturers and Authorised Representatives etc., has been available since December 2020.
According to current (May 2021) estimates, the module for device/UDI registrations will become available in September 2021.
We are a European manufacturer of Class IIa medical devices, I want to know what we have to do to obtain the SRN number, I appreciate if you can help us,
Thanks in advance,
This document from the EU Commission describes the process: http://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_actor_registration_request_process_en.pdf
Thank you for this information.
Approximately long after submission of the actor registration module should we expect to get our assigned SRN?
In May 2021 this is still a new procedure and currently the delays experienced can vary. But the SRN can be received on the same day as the registration is submitted. It depends on the Competent Authority and their configuration of the Actor module.
It has been 5 days since our submission has been verified and we STILL do not have an SRN. There is no answer to emails sent inquiring either!
Thank you for the feedback. The time will likely vary according to the internal procedures of the specific Competent Authority involved. Some companies have reported a delay of up to one month in some circumstances.
Thank you for your support in advance,
When I said non CE marked medical devices, I was referring to the following situation:
Do medical devices sold outside the Union require UDIs on the label and packaging? In this case, the devices may be authorized under the national legislation of the respective destination.
Yes. You must consult the regulations of the concerned country.
I have 2 questions for you, please.
a. We are manufacturer of medical devices class III implantable certificated under MDD and will expiry in 2022, september. I have obtained SRN. We would like to apply for UDI. This module in Eudamed, is not available in this moment. When we get the IDU for each device, do we place it on the label and packaging? Before certification under MDR?
and b:
Is UDI obtained for both CE marked and non-CE marked devices?
Thank you so much
UDIs are not issued to the manufacturer from EUDAMED. UDIs are issued to the manufacturer by a UDI issuing entity and then registered in EUDAMED by the manufacturer.
There are several UDI issuing entities, possibly the company from which you already obtain the barcodes for your products.
You write that you are a manufacturer of a Class III MDD device. Please note: If you are intending to continue to place that device on the market until 2022, by following the transitional provisions in Art. 120; then your device is a so called “legacy device” and you do not need to assign a UDI. Read MDGC Guidance document 2019-5 Registration of legacy devices in EUDAMED.
What do you mean “non-CE marked devices”?
Once we do have our SRN number, do we need to have this number printed on our product labels?
No, not on labels. But the SRN must appear on the EU Declaration of Conformity and, if applicable, on any Summary of Safety and Clinical Performance or Field Safety Notice.
When will Non-EU manufacturers (UK) be able to register with EUDAMED?
The so-called Actor (economic operator) registration module was made available to users on 1st December 2020. Go to https://ec.europa.eu/tools/eudamed/
Is the SRN unique to a Device? And that the SRN will be same for The Manufacturer, It’s AR and It’s Importer?
Or, Is a Unique SRN a one time thing given to a Manufacturer and it’s EOs just once and will be same for all the devices that the manufacturer produces?
Each concerned Economic operator (manufacturer, authorised representative, importer, system/procedure pack producer) obtains their own unique SRN when they register as an Actor in EUDAMED.
Hi,
We are a EU distributor who import a medical product directely from the US – but we are not the EC representative for the device, this is another EU company.
1. Are we seen as the importer (under MDR article 13) or only the distributor (under MDR article 14)?
2. Do we need to have a SRN number?
Thanks
Based on your description, your company is fulfilling the definition of an Importer according to the EU MDR and the Blue Guide. As a result, you should fulfil the obligations in Article 13 and register in the EUDAMED Actor module to obtain your SRN.
Hello
We are a non EU manufacturer of Annex XVI products (meaning products without medical purpose that are not MDD regulated but will be regulated under the MDR on May 2021).
When will we be required to register in the actor registration module?
When will we be required to register our products in the UDI-DI module?
Thanks
Thank you for your question about EUDAMED
The EUDAMED Actor (economic operator) registration module became available on 1 December 2020. The UDI/devices registration module is expected to be the next module to become available. You can follow the progress of the EUDAMED roll-out on the Commission website: https://ec.europa.eu/health/md_eudamed/overview_en
I am a UK distributor of an Australian CE Marked device
When I re-sell the device into Europe do I need to appoint a responsible person in each country?
Thank you for your question about the authorised representative.
According to the regulation, “the manufacturer designates a sole authorised representative” within the Union.
Hello,
Does the importer have to be the actual company inside the EU receiving payment for the goods? For example can the Distributor buy the goods directly from the non-EU manufacturer and on the label the Importer & EC REP be a single entity registered inside the EU but not involved some commercial transactions?
Thank you for your question about importers.
The importer is by definition placing the third country product on the EU market. It is essential therefore, that the importer in your business model fulfils the definition of placing on the market. You should be aware that the definitions of importer and placing on the market found in the EU MDR are shortened versions. For the full definitions you should refer to the European Commission’s ‘Blue Guide’ on the implementation of EU products rules 2016.
In order to receive a SRN, can a Class IIa manufacturer do this on their own or does the Notified Body have to obtain it for the manufacturer?
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.
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.
Martin
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.
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.
Updated reply: The EUDAMED Actor (economic operator) registration module became available on 1 December 2020. The UDI/devices registration module is expected to be the next module to become available. You can follow the progress of the EUDAMED roll-out on the Commission website: https://ec.europa.eu/health/md_eudamed/overview_en
Since EUDAMED will not be live on the date of application of the MDR, what information must be “registered” by the DoA?
Updated reply: On 1st December 2020 the “Actor” registration module became available for economic operators (Actors) to register. Go to https://ec.europa.eu/tools/eudamed/
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.
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.
What is my srn number
Updated reply: An overview of EUDAMED and information on its current status is available at https://ec.europa.eu/health/md_eudamed/overview_en
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.
Updated reply: On 1st December 2020 the “Actor” registration module became available for economic operators (Actors) to register. Go to https://ec.europa.eu/tools/eudamed/