Kiri

Tere

Täname päringu eest.

Dokumentide uuendamine MSA-s ei ole seadusega sätestatud kohustuslik tegevus. Sellegipoolest soovitame võimalusel dokumente ja andmeid uuendada, eriti juhul, kui muutub seadme ankeedis kirjas olev info, näiteks volitatud esindaja või teavitatud asutuse number. Kui MSA-s on teavitatud seadme levitamisest ja seal on kirjas kindlad REF numbrid/mudelid ning muudatus puudutab neid (st uued numbrid, mida MSA-s ei kajastu), siis tuleb uuendada. Vastasel korral ei ole muutunud REF numbriga seadmest/mudelist teavitatud ehk levitamisest teavitamise kohustus on täitmata.

Kui muutub aga seadme tootja, käsitleme seda kui uut seadet ning sellisel juhul tuleks teha uus levitamisest teavitamise taotlus.

Tere

Edastan tootja B.Braun Melsungen küsimuse:

I am contacting you regarding the topic of global changes impacting the approved registration certificate/registered documentation / notification for medical devices (active, non-active), as I would require your support in better understanding which types of global changes would have an effect in your country.

The reason for this query is to become more efficient in the future, when evaluating the global impact of the changes, and to get in contact and inform you only when this would be applicable for you.

Please, answer on the following:

1. Do you have to inform the Authority about any changes? Yes/No

2. In case, the answer to the question 1 is ‘Yes’, which changes do you have to submit to the Authority?

3. Is there a law/guideline regulating the changes which have to be submitted to the Authority? Yes/No

if ‘Yes’, please, send the full version of the regulation in your language and just translate necessary part regarding changes’ impact into English.

Seni tuli teavitada seadmel tehtavatest olulistest muudatustest (kuigi ka need ei olnud väga täpselt määratletud).

Ette tänades,

Toomas Puskarjov

Regulatory Affairs Manager

Compliance Officer

+372 5139366

[email protected]

B. Braun Medical OÜ

Pilvetee 8

12618 Tallinn

Estonia

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