This page is no longer maintained. On 26 May 2021 the EUMDR entered into application and the MDD was repealed.
The essentials of registration under new European Union Medical Device Regulation (EU MDR) are very similar to those under the current Medical Device Directive (MDD). Namely, those placing medical devices on the European market have to register, as do the Authorised Representatives of non-European Manufacturers, and provide the details of the devices they are placing on the European market bildquelle. In a nutshell, the changes in the new EU MDR primarily involve an extension of the scope of those who have to register, now applicable also to importers of medical devices, and the amount of data to be provided about each device, which has expanded considerably.
The current MDD’s single Article on registration, Article 14, is replaced by several Articles in the EU IVDR. Primarily; the new Article 29 “Registration of devices”, the new Article 30 “Electronic system for registration of economic operators”, and the new Article 31 “Registration of manufacturers, authorised representatives and importers”. In practice, the steps involved in registering are in reverse order to the Articles: Economic operators must first apply (new Article 31) and be issued with a “single registration number” (SRN). They can then register their devices using this new SRN (new Article 29). This new SRN is not only a prerequisite to being able to register devices in the database, it is also prerequisite to being able to submit an application for assessment to a Notified Body.
According to the new Article 31, the economic operators who are required to register according to the new EU IVDR are Manufacturers and their Authorised Representatives, the same as under the current MDD, now joined by Importers of medical devices. Additionally, the new Article 30 allows EU Member States to establish local registration schemes for distributors of medical devices within their national territories. Once more is known about Distributor registration this page will be updated.
The information required to register an Economic operator (new Article 31) is specified in Section 1 of Part A of Annex VI; the type of economic operator, their name and address and details of contact persons. Again, this is really no different to the current IVDD. In contrast, the information required to register a medical device (new Article 29) has changed beyond recognition compared to the current MDD. The new information requirements, which are listed in Part A (2) and Part B of Annex VI, are considerable. More than 30 elements of data will be required in the database for each medical device, including the new UDI-DI (Device Identifier).
Additionally, according to the new Article 30, within two weeks of placing a device on the market, Importers must perform a compliance check on their suppliers. Importers must verify the information in the registration database is correct and inform the Manufacturer or Authorised Representative if any information is incorrect.
Once more is known about the practicalities of registration process and the availability of the registration database, this page will be updated.
Hi, has there been any update to this since 2018?
Thank you!
Thank you for your question
Yes, the EUDAMED registration module for so called “Actors” (i.e. manufacturers, authorised representatives, importers, producers of systems and procedure packs) is planned to go live in December 2020. Anticipating this, information on how to register and obtain the SRN was published on the EU Commission website in October 2020 at the link below.
https://ec.europa.eu/health/md_eudamed/actors_registration_en
Is it compulsory for a manufacturer to have an EU Importer to place devices in the EU Market, or can Medical Devices continue to be supplied from a distributor in the UK. The manufacturer has an Authorised Representative in EU27 and all devices are registered and CE certified.
As stated elsewhere, importers do not have to be appointed. Any EU based legal entity, or citizen, that imports goods into the EU is by definition an importer and automatically subject to the obligations of importers. Additionally, the obligations of importers are not new; they already existed under the MDD. See the ‘Blue Guide’ on the implementation of EU products rules 2016”.
Natarajan from Singapore.
We are in the process of filing our application for MDR. But it looks like we need to get UDI-DI and SRN number prior to submission of our application.
We are going for MultiSite (Singapore plant [main site] and Vietnam Plant) Certification.
We have identified ER Rep but we have not yet officially Signed the contract.
How do we get those numbers SRN & UDI-DI. Can we use the barcode on our product as UDI number. Have 8 products under one family so how many UDI-DI numbers need to be generated.
Does the labels on products manufactured at Vietnam needs to have Singapore manufacturing address or can use Vietnam address.
Please advise.
Thank you for your questions.
To obtain the UDI numbers you must apply to one of the issuing entities named in the Commission’s implementing decision (EU) 2019/939.
Until EUDAMED is available your Authorised Representative must register your company and your devices with the local Competent Authority in the EU state or where they (the Authorised Representative) are located.
The label must show the name and address of the (legally responsible) manufacturer. It is the same manufacturer’s name and address shown on the declaration of conformity, and the same manufacturer’s name and address that is registered with the competent authority.
Article 30 allows EU Member States to establish local registration schemes for distributors of medical devices within their national territories. Where do I find a list of which EU Member States that actually establish registration schemes for distributors?
Thank you for your question about distributors’ registration.
As distributor registration is a national matter, if you are a manufacturer your own distributors are likely to be the best source for this information. Alternatively, your industry association may have already compiled this information.
Hello,
I’m just wondering whether the importer needs to apply for SRN means they would be appeared on UDInumber?
Thank you.
Thank you for your question about distributors registration obligations.
The obligation to register the device is with the manufacturer – Article 10(11), or their authorised representative – Article 11(3c). Importers verify that the device has already been registered and add their details to the already existing registration – Article 13(4).
We are a manufacturer of dental devices in the USA that sells in multiple EU countries. Do we obtain the our SRN directly or do we have obtain it through either our AR or one of our distributors in the EU.
Thank you for your question about the Single Registration Number (SRN).
The European Commission has announced that the electronic system EUDAMED will not be available until May 2022 at the earliest. In these circumstances, according to Article 123(3d), the current (MDD’s) national arrangements will continue in place, including for registration of devices and of economic operators.
I am a class 1 manufacturer of prosthetic components (external) and we export to EU. I currently have a CE declaration to original MDD and a AR in Germany. I am trying to complete new declaration but have a number of questions. First, in order to do this declaration to the EU 2017/745 I need a SRN on it right? Where do I go to get it? Second, I have hundreds of sku’s, do I need to list every part number (UDI-DI) on the declaration? Currently my product line is summarized as a product group = Prosthesis, Leg UMDNS Code 13160. Third, are GS1 bar codes required as UDI-DI? We currently have bar codes (an are human readable) on packages that have part number and lot code.
Thank you for your questions.
(1) The SRN as envisaged would have been provided by EUDAMED. However, EUDAMED will not be available until 2022. In the meantime, registration will continue as a national process. Please confirm with your authorised representative whether their national competent authority intends to issue an SRN in place of EUDAMED.
(2) The EU Declaration of Conformity must contain the Basic UDI-DI or BUDI-DI (GS1 term Global Model Number), not all UDI-Dis in the product family.
(3) Please confirm with one of the four UDI issuing agencies whether your current bar codes meet the EUMDR specification for UDI.
If a company has a campus with different businesses, each being a legal manufactuer and establsihed QMS, in some cases different Notified Bodies, can they get their own SRN or will EUDAMED force them to have only one SRN? The CE Certs, IFU and Product lable all say the same for the 3 Businesses.
Thank you for your question about the Single Registration Number (SRN).
At the time of writing this reply we are still waiting for more information to be published on the procedure for issuing of the SRN. However, you wrote “The CE Certs, IFU and Product label all say the same for the 3 Businesses.” That suggests three business units operating within the same legal entity (registered business). In that case it seems likely that the devices of all three business will share the same SRN in the database.
Hello, looking into SRN for the company. Will SRN be the same number as the UK Government EORI (economic operator registration identifier) number? Will these number/s need to be included on the product labelling like UDI numbers?
Thank you for your question about the Single Registration Number (SRN).
The SRN is issued by the EU Competent Authority in which the economic operator has its registered place of business. For as long as the UK remains a member of the EU, economic operators based in the UK can register with MHRA via the Device Online Registration System (DORS). Other EU Competent Authorities have their own arrangements for economic operators in their countries.
Where is the SRN used? The SRN must appear on the EU Declaration of Conformity. If applicable, the SRN must be included in the Notified Body application and will be shown in any Notified Body certificates. The SRN is included in the data submitted to the EUDAMED database and in the Summary of Safety & Clinical Performance (SSCP). If applicable, the SRN must also be included in any Field Safety Notices.
Wil there be a SRN issued for each product number or will the UDI-DI be used as the product identifier?
Thank you for your question. A Single Registration Number (SRN) is the company/legal entity identifier and will be assigned to each registered economic operator; Manufacturer, Authorised Representative or Importer. Whereas the UDI-DI is the specific product/device identifier.