Registration Requirements Tool

Austria

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Belgium

Is additional registration required: Yes

Registration Process: A notification form must be submitted in an online database before the product is placed on the market. The notification must be submitted by the importer or distributor. If the importer is not located in Belgium, there is a specific module in the FAMHP database the company should use for entities based outside of the country.

There is no fee associated with the notification. However, distributors and importers notifying devices in the database pay an annual fee to FAMHP. More information about fee payments can be found here.

Additional Notes: All devices require registration, including class I products.

Info Required: Database form entry to include general device info, general info about the manufacturer, AR and distributor

Helpful Links:

• Registration Database Overview
• Registration Database
• Registration FAQs

Bulgaria

Is additional registration required: The Bulgarian Competent Authority established the below notification process for companies to follow, but it is not mandatory by the Medical Device Law (linked below).

Registration Process: A notification form can be submitted via email to the Bulgarian CA at bda@bda.bg before the product is placed on the market. The notification can be completed by the Manufacturer, Authorized Representative or Distributor. There is no fee to complete the notification.

Manufacturers can begin commercializing their device upon submission – no formal confirmation from BDA is needed.

Additional Notes: While not required by law, the Bulgarian Competent Authority also has a form to complete IVD notifications per IVDD article 10(6), if manufacturers choose to submit this information.

Info Required: Application form (linked below), DoC, CE certificate, label, Bulgarian IFU

Helpful Links:

• Medical Devices Act - Registration Requirement in Article 30
• Registration Forms

Croatia

Is additional registration required: Yes

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.

Additional Notes: Croatia requires registration of class IIa, IIb, III and AIMD medical devices, and for all classes of IVDs, including other/self-certified.

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

Helpful Links:

• Registration Process
• Registration Forms

Cyprus

Is additional registration required: Yes

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

Helpful Links:

• Registration Process
• Registration Forms

Czech Republic

Is additional registration required: Yes

SUKL will review the notification submission in the database and may follow up to request additional information. Upon completion of the review, the CA will mark the entry as accepted. There is no fee for the device notification.

Additional Notes: In cases where the manufacturer is placing the product directly on the market (e.g, SaMD), the Authorized Representative must submit the notification.

Info Required: Database form entry to include general device info, manufacturer info, Basic UDI-DI (if available) plus upload of CE certificate, label and Czech IFU

Helpful Links:

• Medical Device Law – medical device requirement included in § 23 - 25 of Law No. 89/2021 Coll.
• IVD Law - IVD requirement included in § 33 of Act No. 268/2014 Coll.
• Database Help Guides
• Database Link

Denmark

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Estonia

Is additional registration required: Yes

Registration Process: The notification must be submitted in an online database within 10 days of placing the product on the market - there is no fee. The notification must be submitted by the primary distributor. Each distributor is not required to submit a notification. This is because the Estonian Competent Authority uses the database to understand if a specific product was placed on the market for post-market surveillance purposes (e.g., in case of a recall). However, they don’t need to know about each individual entity commercializing the device.

Additional Notes: In cases where the manufacturer is placing the product directly on the market (e.g, SaMD), the Authorized Representative can create a database account and submit the notification. For professional-use devices, hospitals also have the option to register the device in the database directly, in place of an importer or distributor.

Info Required: Database entry form to include general device info, manufacturer and AR info plus upload of the label, original and Estonian IFU, CE Certificate, DoC

Helpful Links:

• Registration Requirements
• Database Link

Finland

Is additional registration required: Yes, but only certain devices and currently postponed until 2023 (see below)

Registration Process: Devices supplied by Finnish distributors to hospitals and retailers require notification to Fimea. Distributors are required to submit a list of these types of products on an annual basis. Fimea is working on an online database where distributors can submit notifications, but it is still under development. Therefore, Fimea announced that distributors are not required to notify in 2022. Fimea will provide additional information on the process and requirements in 2023.

Helpful Links:

• Registration Requirements
• Fimea Announcement – Distributors not required to notify in 2022

France

Is additional registration required: Yes

Registration 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.

Additional Notes: ANSM announced that devices can be registered in EUDAMED now to fulfill the national registration requirement, instead of the email notification described above. If a device is notified in EUDAMED, ANSM does not need to be informed directly. However, they may audit devices to confirm accuracy of the information 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 and Forms
• ANSM Announcement – Use of EUDAMED

Germany

Is additional registration required: Registration may be required, see additional notes

Additional Notes: Registration of a medical device or IVD may be required if an Importer, Authorized Representative or Manufacturer located in Germany is placing the product on the market for the first time. However, BfArM is transitioning some of the registration obligations from their local database (DMIDS) to EUDAMED and altering the overall requirements. Therefore, if a manufacturer is selling through a German importer, we suggest confirming directly with this entity which registration obligations may apply to their products.

Authorized Representatives and manufacturers not based in Germany do not have any registration obligations. Therefore, manufacturers selling direct to the end-user do not need to notify, unless they or their Authorized Representative is based in Germany.

Helpful Links:

• BfArM Registration Database FAQs

Greece

Is additional registration required: Yes

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

Additional Notes: Distributors have an additional obligation to register devices in the Greek CA’s database (announcement linked below).

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

Helpful Links:

• Registration Requirements – see section “Notification of Medical Devices"
• EOF Announcement – Distributor Notification Requirement

Hungary

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements – Directives
• Registration Requirements – Regulations

Iceland

Is additional registration required: No – only certain local Economic Operators have registration obligations

Additional Notes: If a manufacturer is selling direct, it is unclear from the website if manufacturers or their ARs need to notify. To err on the side of caution, the manufacturer or the AR can register, but may not receive confirmation of receipt from the CA. In these cases, manufacturers can begin marketing upon submission of the notification form.

Helpful Links:

• Registration Requirements and Form

Ireland

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Italy

Is additional registration required: Yes

Registration Process: 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 fee associated with the notification.

Additional Notes: 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:

• Medical Device Registration Requirements
• IVD Registration Requirements
• Database Registration Forms
• Registration Database

Latvia

Is additional registration required: Yes

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

Info Required: Registration form entry to include general device info, manufacturer and AR info, DoC, CE Certificate

Helpful Links:

• Online Registration Form - Requirement to register noted at the top of the form

Liechtenstein

Is additional registration required: No – medical devices that meet the regulatory requirements in either the EU or Switzerland can be placed on the market with no further requirements

Helpful Links:

• Registration Requirements

Lithuania

Is additional registration required: Yes

Registration Process: The notification must be submitted via email to the Lithuanian CA at vaspvt@vaspvt.gov.lt. It must be submitted within 14 days of placing the product on the market and can be submitted by the Authorized Representative, Manufacturer or Distributor. There is no fee for the notification.

Additional Notes: Only class IIa, IIb, III and AIMD medical devices require notification. IVDs do not require notification.

Info Required: Application form (linked below), label, Lithuanian IFU

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 additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Malta

Is additional registration required: No – only local Economic Operators have registration obligations

Additional Information: The Maltese CA website does not explicitly state that registration is only required for local economic operators. However, the CA confirmed via email in December 2022 that foreign manufacturers do not have registration obligations.

Netherlands

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Norway

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Poland

Is additional registration required: Yes

Registration Process: 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.

Additional Notes: All devices require notification, including self-certified medical devices and IVDs.

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

Helpful Links:

• Registration Requirements
• Registration Forms

Portugal

Is additional registration required: Yes

Registration Process: The Portuguese notification must be submitted in an online database prior to placing the product on the market. The product can be placed on the market as soon as the notification is processed in the database. The notification can be submitted by the Authorized Representative or Manufacturer. The submitter must apply for or already have an Infarmed database account. There is no fee for the Infarmed notification.

Info Required: General device info, manufacturer and AR info, label, Portuguese IFU, DoC, CE certificate

Helpful Links:

• Registration Requirements
• Infarmed Database

Romania

Is additional registration required: No – only local Economic Operators have registration obligations

Additional Notes: Until recently, ANMDMR required foreign manufacturers to notify high risk devices once they were placed on the market. However, on 20 July 2021, the CA announced that this requirement no longer applies. Therefore, notifications for foreign manufacturers are no longer needed in this market. Romanian manufacturers still have notification obligations for certain device classes (see below link).

Helpful Links:

• ANMDMR Announcement – Registration Not Required for Foreign Manufacturers
• Registration Requirements - Romanian ARs and Manufacturers

Slovakia

Is additional registration required: Yes

Registration Process: The Slovakian notification is submitted via an online form. The notification must be submitted before the product is placed on the market. SUKL will review the notification and may follow up to ask questions or request additional information.

The notification can be submitted by the Authorized Representative, Manufacturer, Distributor or Importer. There is also an option for the Manufacturer to formally appoint another entity to submit on their behalf. There is a small fee associated with the notification - €20.00 per notification.

Info Required: Cover letter (template linked below), application form (linked below), device appendix (linked below), billing proposal (included in form link below), label, Slovakian IFU, DoC, CE certificate

Helpful Links:

• Registration Requirements and Forms
• Submission Form

Slovenia

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Spain

Is additional registration required: Yes

Registration Process: The Spanish notification must be submitted in an online database prior to placing the product on the market. The product can be placed on the market as soon as the notification is processed in the 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 Notes: AEMPS requires that labels include the product’s description or intended purpose in Spanish. This is noted in Royal Decree 1591/2009, Article 4(2), which references Annex 1, Article 13. The label requirement is noted specifically in 13.1.

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 1591/2009
• Registration Requirements
• Registration Database FAQs
• AEMPS Database

Sweden

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Switzerland

Is additional registration required: No – registration of some devices currently only required for Swiss Manufacturers (see requirements here)

Additional Notes: Swissmedic plans to introduce a registration system (Swissdamed) in 2023. But, at this time registration for most devices is not required. Additional requirements still 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:

• Medical Device Registration Requirements
• IVD Registration Requirements

Turkey

Is additional registration required: Yes

Registration Process: 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 Notes: 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
• Database User Guide

United Kingdom

Is additional registration required: Yes

Registration Process: 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. A fee of GBP 100 applies per submission.

Additional Notes: 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

Manufacturers based outside the EU should confirm if their Competent Authority has any local registration requirements that apply to their AR and/or their devices.

Registration Requirements Tool

Austria

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Belgium

Is additional registration required: Yes

Registration Process: A notification form must be submitted in an online database before the product is placed on the market. The notification must be submitted by the importer or distributor. If the importer is not located in Belgium, there is a specific module in the FAMHP database the company should use for entities based outside of the country.

There is no fee associated with the notification. However, distributors and importers notifying devices in the database pay an annual fee to FAMHP. More information about fee payments can be found here.

Additional Notes: All devices require registration, including class I products.

Info Required: Database form entry to include general device info, general info about the manufacturer, AR and distributor

Helpful Links:

• Registration Database Overview
• Registration Database
• Registration FAQs

Bulgaria

Is additional registration required: The Bulgarian Competent Authority established the below notification process for companies to follow, but it is not mandatory by the Medical Device Law (linked below).

Registration Process: A notification form can be submitted via email to the Bulgarian CA at bda@bda.bg before the product is placed on the market. The notification can be completed by the Manufacturer, Authorized Representative or Distributor. There is no fee to complete the notification.

Manufacturers can begin commercializing their device upon submission – no formal confirmation from BDA is needed.

Additional Notes: While not required by law, the Bulgarian Competent Authority also has a form to complete IVD notifications per IVDD article 10(6), if manufacturers choose to submit this information.

Info Required: Application form (linked below), DoC, CE certificate, label, Bulgarian IFU

Helpful Links:

• Medical Devices Act - Registration Requirement in Article 30
• Registration Forms

Croatia

Is additional registration required: Yes

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.

Additional Notes: Croatia requires registration of class IIa, IIb, III and AIMD medical devices, and for all classes of IVDs, including other/self-certified.

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

Helpful Links:

• Registration Process
• Registration Forms

Cyprus

Is additional registration required: Yes

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

Helpful Links:

• Registration Process
• Registration Forms

Czech Republic

Is additional registration required: Yes

SUKL will review the notification submission in the database and may follow up to request additional information. Upon completion of the review, the CA will mark the entry as accepted. There is no fee for the device notification.

Additional Notes: In cases where the manufacturer is placing the product directly on the market (e.g, SaMD), the Authorized Representative must submit the notification.

Info Required: Database form entry to include general device info, manufacturer info, Basic UDI-DI (if available) plus upload of CE certificate, label and Czech IFU

Helpful Links:

• Medical Device Law – medical device requirement included in § 23 - 25 of Law No. 89/2021 Coll.
• IVD Law - IVD requirement included in § 33 of Act No. 268/2014 Coll.
• Database Help Guides
• Database Link

Denmark

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Estonia

Is additional registration required: Yes

Registration Process: The notification must be submitted in an online database within 10 days of placing the product on the market - there is no fee. The notification must be submitted by the primary distributor. Each distributor is not required to submit a notification. This is because the Estonian Competent Authority uses the database to understand if a specific product was placed on the market for post-market surveillance purposes (e.g., in case of a recall). However, they don’t need to know about each individual entity commercializing the device.

Additional Notes: In cases where the manufacturer is placing the product directly on the market (e.g, SaMD), the Authorized Representative can create a database account and submit the notification. For professional-use devices, hospitals also have the option to register the device in the database directly, in place of an importer or distributor.

Info Required: Database entry form to include general device info, manufacturer and AR info plus upload of the label, original and Estonian IFU, CE Certificate, DoC

Helpful Links:

• Registration Requirements
• Database Link

Finland

Is additional registration required: Yes, but only certain devices and currently postponed until 2023 (see below)

Registration Process: Devices supplied by Finnish distributors to hospitals and retailers require notification to Fimea. Distributors are required to submit a list of these types of products on an annual basis. Fimea is working on an online database where distributors can submit notifications, but it is still under development. Therefore, Fimea announced that distributors are not required to notify in 2022. Fimea will provide additional information on the process and requirements in 2023.

Helpful Links:

• Registration Requirements
• Fimea Announcement – Distributors not required to notify in 2022

France

Is additional registration required: Yes

Registration 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.

Additional Notes: ANSM announced that devices can be registered in EUDAMED now to fulfill the national registration requirement, instead of the email notification described above. If a device is notified in EUDAMED, ANSM does not need to be informed directly. However, they may audit devices to confirm accuracy of the information 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 and Forms
• ANSM Announcement – Use of EUDAMED

Germany

Is additional registration required: Registration may be required, see additional notes

Additional Notes: Registration of a medical device or IVD may be required if an Importer, Authorized Representative or Manufacturer located in Germany is placing the product on the market for the first time. However, BfArM is transitioning some of the registration obligations from their local database (DMIDS) to EUDAMED and altering the overall requirements. Therefore, if a manufacturer is selling through a German importer, we suggest confirming directly with this entity which registration obligations may apply to their products.

Authorized Representatives and manufacturers not based in Germany do not have any registration obligations. Therefore, manufacturers selling direct to the end-user do not need to notify, unless they or their Authorized Representative is based in Germany.

Helpful Links:

• BfArM Registration Database FAQs

Greece

Is additional registration required: Yes

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

Additional Notes: Distributors have an additional obligation to register devices in the Greek CA’s database (announcement linked below).

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

Helpful Links:

• Registration Requirements – see section “Notification of Medical Devices"
• EOF Announcement – Distributor Notification Requirement

Hungary

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements – Directives
• Registration Requirements – Regulations

Iceland

Is additional registration required: No – only certain local Economic Operators have registration obligations

Additional Notes: If a manufacturer is selling direct, it is unclear from the website if manufacturers or their ARs need to notify. To err on the side of caution, the manufacturer or the AR can register, but may not receive confirmation of receipt from the CA. In these cases, manufacturers can begin marketing upon submission of the notification form.

Helpful Links:

• Registration Requirements and Form

Ireland

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Italy

Is additional registration required: Yes

Registration Process: 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 fee associated with the notification.

Additional Notes: 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:

• Medical Device Registration Requirements
• IVD Registration Requirements
• Database Registration Forms
• Registration Database

Latvia

Is additional registration required: Yes

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

Info Required: Registration form entry to include general device info, manufacturer and AR info, DoC, CE Certificate

Helpful Links:

• Online Registration Form - Requirement to register noted at the top of the form

Liechtenstein

Is additional registration required: No – medical devices that meet the regulatory requirements in either the EU or Switzerland can be placed on the market with no further requirements

Helpful Links:

• Registration Requirements

Lithuania

Is additional registration required: Yes

Registration Process: The notification must be submitted via email to the Lithuanian CA at vaspvt@vaspvt.gov.lt. It must be submitted within 14 days of placing the product on the market and can be submitted by the Authorized Representative, Manufacturer or Distributor. There is no fee for the notification.

Additional Notes: Only class IIa, IIb, III and AIMD medical devices require notification. IVDs do not require notification.

Info Required: Application form (linked below), label, Lithuanian IFU

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 additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Malta

Is additional registration required: No – only local Economic Operators have registration obligations

Additional Information: The Maltese CA website does not explicitly state that registration is only required for local economic operators. However, the CA confirmed via email in December 2022 that foreign manufacturers do not have registration obligations.

Netherlands

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Norway

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Poland

Is additional registration required: Yes

Registration Process: 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.

Additional Notes: All devices require notification, including self-certified medical devices and IVDs.

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

Helpful Links:

• Registration Requirements
• Registration Forms

Portugal

Is additional registration required: Yes

Registration Process: The Portuguese notification must be submitted in an online database prior to placing the product on the market. The product can be placed on the market as soon as the notification is processed in the database. The notification can be submitted by the Authorized Representative or Manufacturer. The submitter must apply for or already have an Infarmed database account. There is no fee for the Infarmed notification.

Info Required: General device info, manufacturer and AR info, label, Portuguese IFU, DoC, CE certificate

Helpful Links:

• Registration Requirements
• Infarmed Database

Romania

Is additional registration required: No – only local Economic Operators have registration obligations

Additional Notes: Until recently, ANMDMR required foreign manufacturers to notify high risk devices once they were placed on the market. However, on 20 July 2021, the CA announced that this requirement no longer applies. Therefore, notifications for foreign manufacturers are no longer needed in this market. Romanian manufacturers still have notification obligations for certain device classes (see below link).

Helpful Links:

• ANMDMR Announcement – Registration Not Required for Foreign Manufacturers
• Registration Requirements - Romanian ARs and Manufacturers

Slovakia

Is additional registration required: Yes

Registration Process: The Slovakian notification is submitted via an online form. The notification must be submitted before the product is placed on the market. SUKL will review the notification and may follow up to ask questions or request additional information.

The notification can be submitted by the Authorized Representative, Manufacturer, Distributor or Importer. There is also an option for the Manufacturer to formally appoint another entity to submit on their behalf. There is a small fee associated with the notification - €20.00 per notification.

Info Required: Cover letter (template linked below), application form (linked below), device appendix (linked below), billing proposal (included in form link below), label, Slovakian IFU, DoC, CE certificate

Helpful Links:

• Registration Requirements and Forms
• Submission Form

Slovenia

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Spain

Is additional registration required: Yes

Registration Process: The Spanish notification must be submitted in an online database prior to placing the product on the market. The product can be placed on the market as soon as the notification is processed in the 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 Notes: AEMPS requires that labels include the product’s description or intended purpose in Spanish. This is noted in Royal Decree 1591/2009, Article 4(2), which references Annex 1, Article 13. The label requirement is noted specifically in 13.1.

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 1591/2009
• Registration Requirements
• Registration Database FAQs
• AEMPS Database

Sweden

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Switzerland

Is additional registration required: No – registration of some devices currently only required for Swiss Manufacturers (see requirements here)

Additional Notes: Swissmedic plans to introduce a registration system (Swissdamed) in 2023. But, at this time registration for most devices is not required. Additional requirements still 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:

• Medical Device Registration Requirements
• IVD Registration Requirements

Turkey

Is additional registration required: Yes

Registration Process: 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 Notes: 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
• Database User Guide

United Kingdom

Is additional registration required: Yes

Registration Process: 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. A fee of GBP 100 applies per submission.

Additional Notes: 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

Manufacturers based outside the EU should confirm if their Competent Authority has any local registration requirements that apply to their AR and/or their devices.