Küsimused

Dear Lelde Giga,

Thank you for your reply.

Please see the regulation (EU) 2024/1860

The manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.

The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.

As for the language requirements, the manufacturer should probably know what the national requirements are.

Kind regards,

Maarika Ojala

Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri.
This e-mail and any attachments transmitted may contain confidential and privileged information.  If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.

Dear Maarika Ojala,

Thank you very much for your previous response. I would like to clarify whether reports can be submitted in English and to which email address should they be submitted? Thanks in advance!

Best regards

Lelde Ģiga
Market Access and Governmental Affairs Manager Baltics

Medtronic
Baltic Representative Office
M. Nometnu 31-311 | Riga, LV-1002 | Latvia

Mobile +371 28710644
[email protected]
medtronic.com  |  Facebook  |  LinkedIn  |  Twitter  |  YouTube

Dear Lelde Giga,

Thank you for contacting us.

Regulation (EU) 2024/1860 of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices entered into force on 10 January 2025.

Obligations in case of interruption or discontinuation of supply of certain devices are established in the current Regulation (EU) 2024/1860.

Article 10a-interruption or discontinuation of supply guidances and more explanation on this topic, please see the following link

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#article-10a--interruption-or-discontinuation-of-supply

Q&A rev1. Q&A Obligation to inform in case of interruption or discontinuation of supply

MDCG 2024-16 Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

MDCG 2024-16 Annex Device Identification table

Kind regards,

Maarika Ojala

Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri.
This e-mail and any attachments transmitted may contain confidential and privileged information.  If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.

Dear Piret,

I hope you are doing well.

I apologize for bothering you again, but I wanted to check if there are any publicly available updates on the implementation of Article 10a regarding the interruption or discontinuation of supply of certain devices. These provisions were introduced as part of Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 and (EU) 2017/746 concerning the gradual implementation of Eudamed, the obligation to notify in the event of supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic medical devices.

Additionally, I would appreciate any information on whether an online reporting system has already been established, the language requirements for submissions, applicable deadlines, and any other relevant details regarding the reporting process.

Thank you in advance for your time and assistance.

Best regards,

Lelde Ģiga
Market Access and Governmental Affairs Manager Baltics

Medtronic
Baltic Representative Office
M. Nometnu 31-311 | Riga, LV-1002 | Latvia

Mobile +371 28710644
[email protected]
medtronic.com  |  Facebook  |  LinkedIn  |  Twitter  |  YouTube

Dear Lelde Giga,

Estonia will expect the obligation to be carried out as specified in the EU regulation.

Any guidelines agreed on by the member states are expected to be followed as well.

Best regards

Piret Põiklik 

Head of Department

Department of Medical Devices

Phone +372 5853 3610

[email protected] | [email protected]

This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.

Dear Piret Põiklik,

In September I asked you about the reporting of interruptions in the supply of medical devices (art. 10a, Regulation 2024/1086). I asked what is your vision for the introduction of regulation in Estonia? Will it be implemented exactly the same as certain general principles in the EU, or will a more specific arrangement be made for Estonia?

At that time the Q&A had not yet been published, but you indicated that the procedure would be implemented in accordance with EU guidelines and that there are currently no plans to introduce additional requirements.

BR

Lelde Ģiga
Market Access and Governmental Affairs Manager Baltics

Medtronic
Baltic Representative Office
M. Nometnu 31-311 | Riga, LV-1002 | Latvia

Mobile +371 28710644
[email protected]
medtronic.com  |  Facebook  |  LinkedIn  |  Twitter  |  YouTube

Dear Lelde Giga,

Thank you for contacting us.

Could you clarify the specific requirements you are referring to?

Best regards

Piret Põiklik 

Head of Department

Department of Medical Devices

Phone +372 5853 3610

[email protected] | [email protected]

This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.

Hi,

Thank you very much for your previous response.

Considering that the Q&A has now been officially published, is it planned to implement the process as set out in the EU guidelines, or will specific requirements still apply?

Best regards,

Lelde Ģiga
Market Access and Governmental Affairs Manager Baltics

Medtronic
Baltic Representative Office
M. Nometnu 31-311 | Riga, LV-1002 | Latvia

Mobile +371 28710644
[email protected]
medtronic.com  |  Facebook  |  LinkedIn  |  Twitter  |  YouTube

Dear Lelde Giga,

Thank you for contacting us.

Estonia will expect the obligation to be carried out as specified in the EU regulation. Any guidelines agreed on by the member states will also most likely be followed.

Best regards

Piret Põiklik 

Head of Department

Department of Medical Devices

Phone +372 5853 3610

[email protected] | [email protected]

This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.

Good afternoon,

I'm not sure if I'm writing to the right addressee, if I need to write to someone else I'd really appreciate help with contact information.

I would like to clarify some questions that have arisen due to the upcoming changes in the regulatory acts that regulate the reporting of interruptions in the supply of medical devices (art. 10a, Regulation 2024/1086).

I am aware that general guidelines are being developed on cases where reporting is mandatory, etc. I wanted to ask what is your vision for the introduction of regulation in Estonia? Will it be implemented exactly the same as certain general principles in the EU, or will a more specific arrangement be made for Estonia? Will these criteria, in which cases a report is required, remain unchanged in the Estonian situation:

- to limit scope to discontinuations of devices transitioning to the MDR (lack of MDR compliance)

- notification based list of devices published by the European Commission

- notification not required if a successor/replacement device is available

- notification only if expected interruption exceeds 90 days.

Thank you very much for your reply in advance!

Best regards,

Lelde Ģiga
Market Access and Governmental Affairs Manager Baltics

Medtronic
Baltic Representative Office
M. Nometnu 31-311 | Riga, LV-1002 | Latvia

Mobile +371 28710644
[email protected]
medtronic.com  |  Facebook  |  LinkedIn  |  Twitter  |  YouTube

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