Vastuskiri

Dear Bill,

Thank you for your enquiry.

Here are the answers to your questions:

1. Please can you clarify who is able to notify the aforementioned device categories within your national database from the following list of economic operators? 

The distribution notification requirement in Estonia is based on Estonian Medical Devices Act § 26 (4) (https://www.riigiteataja.ee/en/eli/ee/524012023001/consolide/current) which says:

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical or Council Directive 93/42/EEC concerning medical devices or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

Therefore, the notification requirement is mainly for distributors, but in the case of direct distribution from the manufacturer, the manufacturer shall also notify us about the distribution.

The all others may also notify us, but it is not mandatory.

If we are talking about Estonian manufacturers or ARs located in Estonia, then they have an obligation to notify us of placing the class I medical device or IVD medical device on the market 10 days in advance until EUDAMED is mandatory.

2. Further, if the Regulatory Importer or European Authorised Representative can perform the notification of devices within your national database, is MedEnvoy, as a Regulatory Importer and/or European Authorised Representative based in The Netherlands, able to notify the manufacturer’s devices on behalf of the manufacturer? 

It is possible to notify us about devices on behalf of the manufacturer, but the obligation is for distributors as stated previously. To represent a distributor in database a PoA from the distributor is needed.

3.      Additionally, would the registration of devices within EUDAMED (the European Commission’s Database) be sufficient for Estonia’s notification requirements at the current time? 

a.      If the registration of devices within EUDAMED is not sufficient at the current time, please can you confirm if the notification of devices with Terviseamet are mandatory at this moment in time?  

The national distribution notification is separate from the EUDAMED registrations, and it remains in place even when EUDAMED is fully functional.

4.      If national registrations are currently mandatory, please can you additionally clarify for which device categories it is necessary to register devices with Terviseamet?

a.      Our understanding is that the following device classifications must be notified within your national database. 

                                                                                       i.Class IIa Medical Devices;

                                                                                     ii.Class IIb Medical Devices;

                                                                                   iii.Class III Medical Devices;

                                                                                   iv.Class B, C or D In-Vitro Diagnostic Medical Devices.

b.     Please can you confirm if the above understanding is correct?  

Correct, but also systems and procedure pack that are placed on the market under MDR must be notified.

5.      Please can you confirm whether there shall be any applicable costs for registering with Terviseamet and notifying the manufacturer’s devices within the EMDDB? 

There are no fees for distribution notification.

a.      If applicable costs are involved, please can you provide MedEnvoy with some further reference material and/or estimation of the incurred costs for both MedEnvoy’s registration as an Actor and the registration of a manufacturer’s devices? 

6.      Finally, if available, please provide MedEnvoy with an estimation of the applicable timelines that may apply to the processing of MedEnvoy’s registration as an Actor with Terviseamet as well as the notification of a manufacturer’s devices within EMDDB? 

The application must be submitted within 10 days from the start of the distribution of the device. The processing time of the appliction is also 10 working days. Once the application is approved, the device will be publicly visible in the database along with the distributor's information.

Finally, MedEnvoy understands that in order to gain access to the website, MedEnvoy shall forward its IP address to [email protected] with an access request – please can you confirm that this understanding is correct?

Correct, this is a temporary restriction for security reasons which hopefully will be removed in near future.

Please do not hesitate to contact me for further information or any questions.

To whom it may concern, 

Hope that you are doing well. 

My name is Bill Broadley, and I am the primary contact for the European Authorised Representative Service at MedEnvoy Global B.V. (hereafter “MedEnvoy”). 

MedEnvoy is a European Authorised Representative and Regulatory Importer company based in The Netherlands.  

On behalf of MedEnvoy, I am reaching out to inquire about the possibility of registering with the national Competent Authority of Estonia, Terviseamet.  

MedEnvoy wishes to perform notifications/registrations (hereafter “notifications/notify”) of medical devices, in-vitro diagnostic devices and active implantable devices (as applicable), on behalf of non-EU based manufacturers, where MedEnvoy is the Authorized Representative, of the aforementioned device categories (hereafter “manufacturers”), within your national database, Estonian Medical Devices Database (EMDDB).  

MedEnvoy would like to clarify whether the above registration with you shall be possible, request any relevant permissions from you and understand the requirements for registering manufacturers’ devices on behalf of the manufacturers. 

Please find the below the applicable questions where MedEnvoy requests further guidance: 

1. Please can you clarify who is able to notify the aforementioned device categories within your national database from the following list of economic operators? 

a.      Legal Manufacturer (EU or non-EU based)  

b.     European Authorised Representative (mandated legal representative based in the EU for non-EU based manufacturers) 

c.      Importer (who physically imports the devices) 

d.     Regulatory Importer (who makes the initial placement of the device on the market and fulfils the responsibilities of importer as set out in Article 13 of the MDR) 

e.     Distributor (who markets/sells the device within the country) 

2. Further, if the Regulatory Importer or European Authorised Representative can perform the notification of devices within your national database, is MedEnvoy, as a Regulatory Importer and/or European Authorised Representative based in The Netherlands, able to notify the manufacturer’s devices on behalf of the manufacturer? 

3. Additionally, would the registration of devices within EUDAMED (the European Commission’s Database) be sufficient for Estonia’s notification requirements at the current time? 

1. If the registration of devices within EUDAMED is not sufficient at the current time, please can you confirm if the notification of devices with Terviseamet are mandatory at this moment in time?  

4. If national registrations are currently mandatory, please can you additionally clarify for which device categories it is necessary to register devices with Terviseamet?

1. Our understanding is that the following device classifications must be notified within your national database. 

1. Class IIa Medical Devices;

                                                                                     ii.Class IIb Medical Devices;

                                                                                   iii.Class III Medical Devices;

                                                                                   iv.Class B, C or D In-Vitro Diagnostic Medical Devices.

2. Please can you confirm if the above understanding is correct?  

5. Please can you confirm whether there shall be any applicable costs for registering with Terviseamet and notifying the manufacturer’s devices within the EMDDB? 

1. If applicable costs are involved, please can you provide MedEnvoy with some further reference material and/or estimation of the incurred costs for both MedEnvoy’s registration as an Actor and the registration of a manufacturer’s devices? 

6. Finally, if available, please provide MedEnvoy with an estimation of the applicable timelines that may apply to the processing of MedEnvoy’s registration as an Actor with Terviseamet as well as the notification of a manufacturer’s devices within EMDDB? 

Please let me know if you require any further information or clarification regarding the above questions.  

Additionally, please inform us if these questions should be directed to an alternative email address. 

Finally, MedEnvoy understands that in order to gain access to the website, MedEnvoy shall forward its IP address to [email protected] with an access request – please can you confirm that this understanding is correct?

Many thanks for considering the above questions, MedEnvoy looks forward to hearing back from you. 

Kindest regards, 

Bill Broadley