Subject: FW: National requirements for medical devices
From: "Meditsiiniseadmed \(Medical Devices\)" <[email-masked]>
To: "TA Info" <[email-masked]>
Date: Mon, 15 Jul 2024 11:01:56 +0300

Tere

Edastan vastavalt üldtelefonilt saadud juhistele kirja üldmeilile, et 
saaksite leida vastamiseks kõige õigema spetsialisti.

Parimate soovidega

Janne Aule

peaspetsialist

meditsiiniseadmete osakond

+37258668664

 <mailto:[email-masked]> [email-masked]

Terviseamet

+372 794 3500

 <mailto:[email-masked]> [email-masked]
 <http://www.terviseamet.ee/> www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Käesolev kiri on konfidentsiaalne ning mõeldud kasutamiseks kirja päises 
nimetatud isikule/asutusele. Käesoleva kirja mistahes viisil kasutamine või 
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koheselt teavitada kirja saatjat ning kustutada saadud kiri koos kõikide 
lisadega.

From: Ravimiamet <[email-masked]>
Sent: neljapäev, 11. juuli 2024 15:34
To: Meditsiiniseadmed (Medical Devices) <[email-masked]>
Subject: FW: National requirements for medical devices

Tere

Edastan e-kirja.

Heade soovidega

Kärolin Jenas
Ravimiamet
arendus- ja haldusosakonna dokumendihalduse spetsialist

Telefon 737 4140
[email-masked] <mailto:[email-masked]>

Nooruse 1
50411 Tartu
www.ravimiamet.ee <http://www.ravimiamet.ee/>

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From: Nerea Nieto <[email-masked] 
<mailto:[email-masked]> >
Sent: neljapäev, 11. juuli 2024 15:08
To: Ravimiamet <[email-masked] <mailto:[email-masked]> >
Subject: National requirements for medical devices

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

Good morning,

My name is Nerea Nieto, and I am a Regulatory Affairs Technician at BTI 
BIOTECHNOLOGY INSTITUTE.

BTI is a Spanish manufacturer of dental related medical devices. Our devices 
are CE marked and comply with MDD or MDR medical device regulations.

We commercialize our devices in the EU including your country.

We have a question regarding requirements in Estonia on reusable devices 
requiring appropriate cleaning, disinfection and sterilization procedures by 
health professionals before use.

Currently, for these devices BTI provides the user with instructions for use 
with an appropriate protocol for cleaning, disinfection and sterilization 
procedures.

These procedures have been validated according to international standards 
UNE-EN ISO 17665-1:2007 and EN ISO 17664-1:2021.

We would appreciate if you could provide us with the following information:

- Are there specific national requirements in your country for the 
(re)processing (i.e. proper cleaning, disinfection and sterilization) of 
medical devices, different from those set by the MDR or the international 
standards mentioned above?

-If so, could you please provide us with the corresponding legislation or 
guidelines?

 P.S. I would be grateful if this email could be forwarded to the relevant 
person/department.

Thanks in advance for your help.

Best regard,

 <https://www.facebook.com/BTIBiotech>
 <https://twitter.com/BTIBiotech>
 <http://www.linkedin.com/company/bti-biotechnology-institute>
 <http://www.youtube.com/user/BTIBiotech>
 <https://vimeo.com/btibiotech>

 <https://bti-biotechnologyinstitute.com/es/>

Nerea Nieto Ulibarri

Regulatory Affairs Department

Parque Tecnológico de Álava
Leonardo Da Vinci, 14 01510 Miñano (Álava) - España
Tlf: +34 945 297 030  Ext.265 | Fax: +34 945 297 031
 <mailto:[email-masked]> [email-masked]

No me imprimas si no es necesario. Protejamos el medio ambiente

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