According to Article 31 in conjunction with Article 29 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 28 in conjunction with Article 26 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) manufacturers, authorised representatives, and importers are required to register themselves and their products (in the meaning of medical devices, accessories to medical devices, products listed in Annex XVI MDR and in vitro diagnostic medical devices) in the European Database on Medical Devices (EUDAMED), unless the products are custom-made devices, before placing them on the market.

Furthermore, systems and procedure packs, unless they are custom-made, must also be registered in EUDAMED prior to being placed on the market in order to comply with Article 29 MDR. For this purpose, registration in EUDAMED as actors is required in advance for the respective system and procedure pack producers.

Manufacturers of Class III custom-made implantable devices must register in EUDAMED so that the Notified Body can enter the certificate details into EUDAMED in accordance with the legal requirements.

Actors obliged to register

From May 28^th, 2026, the use of the EUDAMED Actor, Product and Certificate Modules will be mandatory. Consequently, from this date, the following economic operators must be registered in EUDAMED before placing products (other than custom-made devices) on the market:

• Manufacturers
• Authorised representatives
• Importers
• System and procedure pack producers (SPPP)

Furthermore, from May 28^th, 2026, certificates issued after this date must be registered in EUDAMED by the Notified Body. To this end, manufacturers (including those of Class III custom-made implantable devices) must already be registered as actors in EUDAMED so that the Notified Body can enter the certificate details into EUDAMED.

If the products were placed on the market before May 28^th, 2026 and continue to be placed on the market thereafter, the device and product registrations must be completed in EUDAMED by November 28^th, 2026 at the latest.

By May 28^th, 2027 at the latest, all certificates must be registered in EUDAMED by the Notified Bodies. However, in order for the Notified Bodies to be able to enter the information relating to their certificates in accordance with the legal requirements, manufacturers (including those of Class III custom-made implantable devices) must already be registered in EUDAMED.

In this context, the BASG would like to point out that applications are processed in the order in which they are received. The time from submission to completion of the processing cannot be predicted, as it depends both on fluctuating application volumes and on the quality and completeness of each individual application.

This is why early registration as an economic operator in EUDAMED is generally recommended.
Failure to meet a legal obligation due to a registration application submitted shortly before the deadline is the sole responsibility of the economic operator.

 Registration process

Economic operators subject to the registration obligation (manufacturers, authorised representatives, importers and SPPPs) submit an application for registration by creating an EU login and entering their data into EUDAMED (EUDAMED - European Database on Medical Devices).

For economic operators established in Austria (as well as SPPPs established outside the Union market whose systems or procedure packs are first placed on the Union in Austria), the Federal Office for Safety in Health Care (BASG) is responsible for checking registration requests for completeness and correctness of the data. If this check is positive, the request will be validated by the BASG and thus the registration process as an actor in EUDAMED will be successfully completed.

For an infographic on this process, see EUDAMED Actor registration request process

Single Registration Number / Actor ID

Once registered, manufacturers, authorised representatives and importers (whose products are not custom-made) receive their Single Registration Number (SRN). Whereas all other actors are assigned an Actor ID after registration is complete.

The SRN or Actor ID serves to uniquely identify the economic operator within the Union. The SRN must be indicated on the EU declaration of conformity and in the documents for the conformity assessment procedure with the involvement of a notified body. 

The use of the other modules of EUDAMED as an economic operator to meet the other legal requirements, such as for the registration of products according to Art. 29 MDR, is only possible with an SRN or Actor ID.

Deficient requests

If a request is incomplete because not all necessary information or documents have been entered or attached, the applicant will receive a request for improvement under Art. 13 Para. 3 of the General Administrative Procedure Act 1991 (AVG), BGBl. Nr. 51/1991, as amended.

Any amendments to the application must be made by the applicant directly in EUDAMED. This can be done via the EUDAMED portal under ‘Pending Requests’. Further information on this can be found in the User Guide provided by the European Commission.

If the missing information or documents are not submitted within the given timeframe, the request will be formally rejected. In this case, a new request must be submitted in EUDAMED for registration.

Withdrawal of a request

According to Art. 13 Para. 7 of the General Administrative Procedure Act 1991 (AVG), BGBl. Nr. 51/1991, as amended, a request may be withdrawn by the applicant at any time during the administrative procedure.

If a request is withdrawn, it must be cancelled in EUDAMED and the BASG must be notified of this by the applicant (preferably by email).

Obligation to update and confirm data

In principle, registered economic operators must keep their data up to date in EUDAMED.

According to Art. 31 Para. 4 MDR and Art. 28 Para. 4 IVDR, manufacturers, authorised representatives and importers - if their products are not custom-made - are obliged to update their reported data in EUDAMED within one week. 

In addition, according to Art. 31 Para. 5 MDR and Art. 28 Para. 5 IVDR, the accuracy of the data must be confirmed by the actor no later than one year after registration and every two years thereafter.

Please note the following information by the European Commission:

Further information on the actor registration (module "Registration of Actors" - Public Health - European Commission) and on EUDAMED in general (User guides and templates) can be found on the website of the European Commission.