Selgitustaotlus

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]
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