Subject: Request for advice on national notification obligations - class IIb medical device
From: "Irene Stebner" <[email-masked]>
To: <[email-masked]>
Date: Thu, 3 Apr 2025 12:22:27 +0300

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

Dear Sir or Madam,

we intend to deliver a class IIb medical device (acc. to Directive
93/42/EEC) to an Estonian Clinic in June 2025. This medical device is
intended for professional users only.

We have been informed by the clinic that a national registration of the
medical device should be required within the MSA system. According to our
research this registration should be done by an Estonian importer or
distributor but we deliver directly to the clinic.

Please advise us on how we should proceed.

Thanks a lot!

Kind regards,
Irene Stebner

  _____

 <https://medical.ezag.com/en/>
	Irene Stebner | Regulatory Affairs Manager
Eckert & Ziegler BEBIG GmbH
Tel: +4930941084422
Sitz Berlin, Amtsgericht Charlottenburg Reg.-Nr. HRB 42949 B
Geschäftsführer: Dr. Dirk W. Becker, Katrin Antonenko