Subject: URGENT_Notification procedure of custom made devices
From: Sandra Steponavičienė | ENERGENAS <[email-masked]>
To: "TA Info" <[email-masked]>
Date: Fri, 3 May 2024 10:38:38 +0300

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

Hello,

Please provide information about notification procedure for custom made
devices in Estonia market (what application distributor should use in MSA
system, what documents should be submitted).

The medical device that distributor wants to make notification is under
Class III Devices (EU Directive 93/42/EEC).

If there it is needed to submit the label please provide information what
distributor should do with the patient name and surname listed on the
label – to cover it up or leave as a confidential information?

Just want to mention concerning the product distributor wants to notify is
already notified in MSA system but not as a custom made.

Thank you in advance for your prompt reply.

Pagarbiai | Best regards,

SANDRA STEPONAVIČIENĖ

aDMINISTRATORĖ / aDMINISTRATOR

ENERGENAS, UAB

t. +370 37 280701   |   m.+370 662 12402   |   w.  <http://energenas.lt/>
energenas.lt