For which market(s) would you like to see the requirements?

Important Note: When completing device registration in EUDAMED, manufacturers must select all countries where the device will be placed on the market. This list must be kept up to date as the device enters additional markets. Failure to select a country means the registration is not considered complete for that market, and the device will not meet the applicable registration requirements.

Austria

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Belgium

Is registration in EUDAMED sufficient: Yes

Notes: As of 28 May 2026, registration in EUDAMED is required for devices that are newly placed on the market in Belgium. Registration through the FAHMP web portal is no longer possible.

Helpful Links:

• EUDAMED Announcement
• Registration Requirements – Class I Devices
• Registration Requirements – IVDs
• Registration Requirements – Systems and Procedure Packs

Bulgaria

Is registration in EUDAMED sufficient: Yes

Notes: The Bulgarian Competent Authority states on their website that the national registration requirements will continue apply until 6 months after the publication in the Official Journal of the EU that the EUDAMED system is fully functional. As this publication occurred on 27 Nov 2025, as of 28 May 2026, it is understood that the national registration requirements no longer apply, and EUDAMED is the applicable registration route.

Helpful Links:

• Medical Devices Act – Registration Requirement in Article 30
• Statement on EUDAMED Registration (scroll down to section “Implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics”)

Croatia

Is registration in EUDAMED sufficient: Yes

Notes: Manufacturers that are eligible for the EUDAMED transition period can choose to either register in EUDAMED or register via Croatia’s national registration process (until 27 November 2026). Manufacturers that are newly placing devise on the EU market must register in EUDAMED, which fulfills Croatia’s national registration requirement.

If submitting through the national registration process, a notification form must be submitted via email to the Croatian Competent Authority at medpro@halmed.hr within 15 days of placing the product on the market. The notification can be completed by any legal or natural persons who place the product on the market. There is no fee to complete the notification.

Info Required: Application form (linked below), list of products appendix (linked below), DoC, CE certificate, label, Croatian IFU

Helpful Links:

• Registration Process (EUDAMED statement at bottom of page)
• Registration Forms

Cyprus

Is registration in EUDAMED sufficient: No, additional notification required

Notes: The Cypriot Competent Authority confirmed via email in June 2026 that the below notification is still required in addition to registration in EUDAMED.

A notification form (linked below) must be submitted via email to the Competent Authority at cymda@mphs.moh.gov.cy before the product is placed on the market. The notification must be submitted by the entity placing the device on the market. There is no fee for the notification.

Info Required: Notification of medical devices form (linked below)

Helpful Links:

• Registration Form

Czech Republic

Is registration in EUDAMED sufficient: No, some local registration requirements still apply

Once the device is registered in EUDAMED, the information will flow over to the local Czech database (ISZP). At that time, the Czech distributor can link themselves to the device registration to indicate the devices they are selling the Czech Republic. If the device has not yet been registered in EUDAMED, the distributor has the option to input it manually into the Czech system.

Helpful Links:

• FAQs on Registration Requirements

Denmark

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Estonia

Is registration in EUDAMED sufficient: Yes, but Estonian distributors still have local registration requirements

Estonian distributors of class IIa, IIb and III and AIMD medical devices, class B, C and D IVDs and systems and procedures packs are still required to register in a local Estonian database.

Helpful Links:

• Registration Requirements
• Database Link – Restricted to users in Estonia or users that have requested access

Finland

Is registration in EUDAMED sufficient: Yes, but with a few exceptions (see below)

Notes: For most economic operators and devices, registration must be completed exclusively through EUDAMED. For non-Finnish entities, the following exceptional cases must be notified in the Finnish national database (CERE): (1) Distributors located abroad who make medical devices available in Finland to retailers, healthcare and social care providers and other professional users; and, (2) Distributors who make available an IVD device intended for self-testing or a device containing human tissue or substances derived from human blood or blood plasma.

There are some additional requirements in CERE for Finnish entities. A full list of these requirements can be found in the below link.

Helpful Links:

• Registration Requirements
• CERE Registration Requirements

France

Is registration in EUDAMED sufficient: Yes

Notes: Manufacturers that are eligible for the EUDAMED transition period can choose to either register in EUDAMED or register via France’s national registration process (until 27 November 2026). Manufacturers that are newly placing devise on the EU market must register in EUDAMED, which fulfills France’s national registration requirement.

If submitting through the French process, the notification must be submitted via email to the French CA at communications.dm@ansm.sante.fr before the product is placed on the market. The notification may be submitted by the Manufacturer, Authorized Representative or Distributor. There is no fee for the notification.

The manufacturer can begin commercializing as soon as the notification is submitted.

Info Required (for email notification): Application form (linked below), label, French IFU, CE certificate, DoC, Certificate of Incorporation (or equivalent document) from entity submitting the notification

Helpful Links:

• Registration Requirements
• ANSM Announcement – Use of EUDAMED

Germany

Is registration in EUDAMED sufficient: Yes

Notes: From May 28, 2026, products newly placed on the market must be registered exclusively via EUDAMED rather than Germany’s national registration system (DMIDS)

Helpful Links:

• BfArM Registration Database FAQs

Greece

Is registration in EUDAMED sufficient: Unknown – the Greek Competent Authority has not confirmed if EUDAMED is replacing the local registration requirements

Notes: As the Greek Competent Authority has not confirmed if EUDAMED is sufficient in lieu of the local registration requirements, it is recommended to continue following the below process until further information is available.

The notification must be submitted via email to the Greek CA at medicaldevices@eof.gr before the product is placed on the market. The notification may be submitted by the Manufacturer or Authorized Representative. There is no fee to submit the notification.

The manufacturer can begin commercializing as soon as the notification is submitted.

Info Required (for Manufacturer/AR notification): DoC, CE Certificate, label, Greek IFU

Helpful Links:

• Registration Requirements

Hungary

Is registration in EUDAMED sufficient: No, additional registration required by local distributor

Helpful Links:

• EUDAMED Actor Registration
• Distributor Device Registration Requirements

Iceland

Is registration in EUDAMED sufficient: Yes

Notes: Icelandic distributors are required to register and keep updated a list of List of brand names they intend to make available on the market, along with a relevant contact person for each brand name.

Helpful Links:

• Registration Requirements and Form

Ireland

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Italy

Competent Authority: Ministero della Salute

Is registration in EUDAMED sufficient: It depends – see below for additional information

Notes: The Italian Competent Authority confirmed that EUDAMED is sufficient to fulfill the national registration requirement. However, registration in the Italian database may still be required to fulfill other conditions for placing products on the market.

• Non-EU Manufacturers: With the exception of class I devices, Customs officers are still requiring non-EU manufactured devices be registered in the Italian database for customs clearance purposes.
• Selling via Public Healthcare System: If manufacturers are selling through the public healthcare system, and require reimbursement or may participate in public tenders, it is still required to register in Italy’s local registration database.

The above is expected to change in the future, with a new Italian database in development. However, until that time, the original database will be maintained. If submitting to meet the above requirements, the notification must be submitted in Italy’s registration database before the product is placed on the market. The notification can be made by the Authorized Representative, Manufacturer, or Distributor. Or, the manufacturer can formally delegate any entity with a database account to submit the notification. There is no Competent Authority fee associated with the notification.

Additional Considerations: It can be challenging for non-Italian entities to obtain a database account as a special type of e-Signature is required that is issued with an authorized certifier in Italy or is compliant with EU Regulation No. 910/2014- The eIDAS (electronic IDentification Authentication and Signature) Regulation.

Info Required: Database form entry to include general device info, manufacturer info, Authorized Representative info and VAT number plus upload of DoC, CE Certificate, label, Italian IFU

If the manufacturer is designating an entity that is not the AR or distributor to submit, an official delegation letter must also be provided with the database submission. A template for this letter is available on the Italian CA’s website.

Helpful Links:

• Implementation of EUDAMED in Italy
• Italian Registration Database Overview
• Registration Database

Latvia

Is registration in EUDAMED sufficient: Yes

Notes: As of 28 May 2026, devices must be registered in EUDAMED before they can be placed on the Latvian market.

Helpful Links:

• EUDAMED Registration Requirement

Liechtenstein

Is registration in EUDAMED sufficient: Yes

Notes: Medical devices that meet the regulatory requirements in either the EU or Switzerland can be placed on the market in Liechtenstein.

Helpful Links:

• Registration Requirements

Lithuania

Is registration in EUDAMED sufficient: Yes

Notes: The Lithuanian Competent Authority states on their website that the national registration requirements will continue apply until EUDAMED is fully functional. As the device/UDI module in EUDAMED is fully functional as of 27 Nov 2025, from 28 May 2026, it is understood that the national registration requirements no longer apply, and EUDAMED is the applicable registration route.

Helpful Links:

• Order V-938: APPROVAL OF THE DESCRIPTION OF THE PROCEDURE FOR THE SUBMISSION OF DATA ON CLASS IIA, IIB, III AND MADE TO ORDER ACTIVE IMPLANTABLE MEDICAL DEVICES
• Registration Requirements and Forms

Luxembourg

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Malta

Competent Authority: Malta Medicines Authority (MMA)

Notes: The Maltese Competent Authority confirmed via email in June 2026 that the below notification is still required in addition to registration in EUDAMED.

1) MT-MDF23 ‘Application Form for Device Registration to place devices on the EU Market – Manufacturers / Authorised Representatives’: Maltese Authorized Representatives and Manufacturers placing devices onto the European market, irrespective of whether they will also place the device on the market in Malta or not.

2) MT-MDF05 ‘Application Form for Notification of Medical Devices Made Available on the Local Market’: Maltese Importers and Distributors making a device available on the market in Malta.

If they have not already done so, the Maltese entity must first register with the MMA before they can submit device applications. The device application must be in either Maltese or English, and once completed, be emailed to mdforms.medicinesauthority@gov.mt. Once the application form has been successfully reviewed, an acknowledgement email will be sent to the applicant. The standard processing time is 30 calendar days. Applicants may opt for a ‘Fast Track Service’, in which the application will be processed within 10 calendar days.

If submitted by the Authorized Representative or Manufacturer, the standard fee is €100 per Declaration of Conformity. If submitted by an Importer or Distributor, the standard fee is €15 per product, and this same fee is also charged on an annual basis. Registration modifications are charged at a standard fee of €100, irrespective of who submits them. The ‘Fast Track Service’ fee is double the standard fee amount.

Additional Notes: Please refer to the guidance documents when completing the application forms. GL-MDF05 ‘Guidance for Application for Notification of Medical Devices Made Available on the Local Market’ applies to Form MT-MDF05. It contains important information, e.g., handwritten application forms will not be accepted; any section not applicable to your organization cannot be left blank, instead it must be filled in with “N/A”. There is no guidance document for Form MT-MDF23; however, we recommend applying the same principles to this form. GL-MDF03/05 ‘Guidance for Application for Revision or Withdrawal of Medical Device Registration’ is available for revision or withdrawal of a medical device registration (Forms MT-MDF03 and MT-MDF05). All fees are outlined in GL-MDF07 ‘Guidance on fees in relation to Medical Devices’.

Info Required: The documentation required depends on the application type.

MT-MDF23 (Manufacturers/Authorised Representatives): Completed and signed registration form (linked below), Excel Sheet MT-MDF23 (embedded in the application form) listing all products, proof of payment, Declaration(s) of Conformity, CE Certificate (if applicable), Instructions for Use, Labels, a copy of the letter of designation issued by the manufacturer appointing the Authorized Representative (for non-EU Manufacturers), and a ‘Declaration of devices being registered through EU Authorised Representative based in Malta’ (for non-EU Manufacturers).

MT-MDF05 (Importers/Distributors): Completed and signed registration form (linked below), Excel Sheet MDF05 (embedded in the application form) listing all products, proof of payment, and notarized copy of the letter of designation between the manufacturer and its European authorised representative (softcopy, if applicable).

Helpful Links:

• Medical Device Registration Forms
• Medical Device Guidance Documents

Netherlands

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Norway

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Poland

Is registration in EUDAMED sufficient: Yes

Notes: As of 28 May 2026, registration in EUDAMED is required for devices that are newly placed on the market. However, until 27 November 2026, the importer also has the option to submit notifications through the Polish notification system, where the product is not yet registered in EUDAMED due to the transitional period.

If notifying through the Polish system, the importer or distributor making product available on the market must notify the Polish CA within 7 days of placing the product on market. The application and accompanying documents can be submitted via email or as a hard copy mailing to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. If submitting the notification via email, application form Annex 1 (linked below) automatically generates the email that is sent to the CA once the submitter clicks the “confirm” button as the bottom of the form. There is no fee for the notification.

Info Required: Application forms Annex 1 and Annex 4, label, Polish IFU, promotional materials specifying the intended use for Poland (if available), DoC, CE Certificate

Helpful Links:

• Registration Requirements

• EUDAMED Announcement

Portugal

Is registration in EUDAMED sufficient: No, some local requirements still apply

Notes: The Portuguese Competent Authority (Infarmed) is maintaining their local registration database. However, it has been updated to integrate with EUDAMED and registration data from EUDAMED will flow over to the Portuguese Database (SIDM). That said, there is some additional action required to comply local Portuguese requirements.

Manufacturers must first register their devices in EUDAMED. Once complete, the Distributor (in the case of non-Portuguese manufacturers) must find the EUDAMED registration details in SIDM and add the medical device code (CDM), Portuguese labeling, and information leaflets. If the device is not yet registered in EUDAMED, it can be manually registered in the SIDM database using the old registration process.

Additional Considerations: Infarmed is also requesting that Distributors take action to link devices already registered in Portuguese with their corresponding EUDAMED entries. There is a tutorial video available here under the Distributor tab.

Helpful Links:

• EUDAMED Announcement
• Registration Requirements
• Infarmed Database
• Public Database

Romania

Is registration in EUDAMED sufficient: Yes

Notes: For local Romanian Economic Operators registering in EUDAMD, the Romanian Competent Authority requires the submission of an additional form (linked below) via email to registratura@anm.ro. This form is an additional verification step for the Economic Operator data. The Romanian CA also charges a fee for this additional verification form.

Further, Manufacturers and Authorized Representatives based in Romania may have additional registration requirements in local Romanian database (further details linked below).

Helpful Links:

• Registration Requirements – Romanian ARs and Manufacturers

• EUDMAD Registration Requirements and Verification Form for Romanian Economic Operators

Slovakia

Is registration in EUDAMED sufficient: No, local notification required in addition to EUDAMED registration

Notes: In addition to the EUDAMED registration, the Slovakian Competent Authority requires a local notification. The notification has been simplified to the local requirements that are not already submitted in EUDAMED, including the Slovakian notification form, billing proposal form (to determine registration fee), instructions for use in Slovak, and Declaration of Conformity. The notification must be submitted by the entity placing the product on the market (either the Manufacturer, Authorized Representative, Importer or Distributor) within 14 days of the date the device is placed on the market. For foreign manufacturers, in most cases, this will be the importer or distributor.

The notification can be submitted via hard copy or electronically using the instructions below. There is a small fee associated with the notification – €23.00 per notification.

Additional Considerations: The Slovakian Competent Authority is also requesting that Economic Operators take action to link devices already registered in Slovakia with their corresponding EUDAMED entries. This task must be completed by 1 January 2027 for Regulation devices and by 1 April 2027 for legacy devices. If the EUDAMED device registrations are not linked to the corresponding Slovakian entries by the aforementioned dates, the devices will be marked as invalid in the Slovakian database. To link the data, Economic Operators must complete the Migration Table (MigracnaTabulka_pomocky.xlsx – available here) and email it to eudamed@sukl.sk. Additional instructions on completing this form can be found here

Helpful Links:

• EUDAMED Announcement – New Notification Requirements and Forms
• Registration Instructions
• Instructions to Submit Notification Electronically

Slovenia

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Spain

Is registration in EUDAMED sufficient: No, local database entry required in addition to EUDAMED registration

Notes: AEMPS is maintaining a local registration requirement, which must be completed in parallel to EUDAMED registration. The current registration database (CCPS) is still in use. A new registry (AEMPS Marketing Register) will eventually be launched that will replace the current system. The release date for the new system is not yet available.

Registration in CCPS must be completed before the product is placed on the Spanish market. The product can be placed on the market as soon as the notification is processed in the CCPS database. However, AEMPS will eventually review the submission to check it has been made correctly and may follow up to ask additional questions.

The notification can be submitted by the Authorized Representative, Manufacturer or Distributor. However, the submitter must apply for or already have an AEMPS database account. AEMPS charges a fee of approximately €100.00 per notification.

Additional Considerations: Economic Operators must update and/or confirm their company and device details in the AEMPS database annually. If the details are not confirmed annually, AEMPS may delete the Economic Operator and device information from the database, and the company would need to re-register before continuing commercialization of the device(s).

Info Required: Database form entry to include general device info, manufacturer and Authorized Representative info plus upload of label (including Spanish description on label), Spanish IFU, DoC, CE certificate

Helpful Links:

• Royal Decree 192/2023
• EUDAMED and Spain Registration Overview
• Registration Requirements
• Registration Database FAQs
• AEMPS Database

Sweden

Is registration in EUDAMED sufficient: Yes

Helpful Links:

• Registration Requirements

Switzerland

Is registration in EUDAMED sufficient: No – Switzerland is a third country with its own registration requirements, so EUDMAED registration is not applicable

Notes: Swissmedic has a registration system (swissdamed), similar to EUDAMED. Device registration became mandatory on 1 July 2026, with a 6-moth transition period until 31 December 2026. By the transition date, all devices must be registered in the system. However, if a device is subject to a vigilance event (e.g., incident, FSCA) prior to the deadline, then it must be registered immediately. Devices are subject to a one-time registration fee of CHF 200 for the first device per year and CHF 20 for each additional device. There is a cap on the registration fee of CHF 10,000.

Additional requirements also apply for Switzerland, including appointment of a Swiss AR, as it is no longer a part of the EU single market for medical devices. Read more about the requirements here.

Helpful Links:

• Device Registration Requirements
• swissdamed Database

Turkey

Is registration in EUDAMED sufficient: No, additional local registration required

Notes: The registration process in the Turkish database remains the same as it did prior to EUDAMED’s mandatory date. The Turkish notification must be submitted in an online database prior to placing the product on the market. The local importer is required to submit the notification. There is a fee associated with the notification.

Additional Considerations: All classes of devices and IVDs require notification. For products sold direct to the consumer, an importer must be identified “in-name only” to submit he notification in the database.

Helpful Links:

• Registration Database Login
• Public Registration Database
• Announcement on EUDAMED and Impact on UTS Database Registration

United Kingdom

Is registration in EUDAMED sufficient: No – the United Kingdom is a third country with its own registration requirements, so EUDMAED registration is not applicable

Notes: Device information must be submitted in the MHRA’s online database before the product can be placed on the market. The MHRA will review the application. The review time quoted by the agency is one week. A formal registration letter is issued as proof of a completed registration. Manufacturers can begin commercializing their device once this letter is issued.

The application must be made by the manufacturer’s UK Responsible person unless the manufacturer is based in the UK. The MHRA charges an annual fee of GBP 300 per level 2 GMDN code registered.

Additional Considerations: Post-Brexit, additional requirements apply for the UK, including appointment of a UK Responsible Person. Read more about the requirements here.

Info Required: Device info, manufacturer and UKRP info, GMDN code, DoC (for self-certified products), CE Certificate (if applicable), agreement/mandate between AR and manufacturer

Helpful Links:

• Registration Requirements
• Registration Database
• Public Database