Saatja: Kärolin Jenas </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=USER3064555E>
Saaja: RA MSO
Teema: FW: MDR-Certified Class IIa Device – VDI UHF-ECG: Request for National Registration/Notification Guidance
From: Marek Sturek <
[email protected]>
Sent: Monday, June 16, 2025 12:48 PM
To: Ravimiamet <
[email protected]>
Subject: MDR-Certified Class IIa Device – VDI UHF-ECG: Request for National Registration/Notification Guidance
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.
Dear Agency,
My name is Marek Šturek, and I am contacting you on behalf of VDI Technologies s.r.o., a medical device manufacturer based in the Czech Republic. We are pleased to inform you that our product, VDI UHF-ECG, has recently received EU MDR (2017/745) certification as a Class IIa medical device.
We plan to make this device available in your country and would like to ensure full compliance with national requirements. Could you kindly provide us with the following information:
1. Is national registration or notification required prior to placing a CE-marked Class IIa device on your market?
2. What documentation is required (e.g., CE Certificate, Declaration of Conformity, GMDN codes, labels, IFU)?
3. What language requirements apply for labeling, Instructions for Use (IFU), and submissions?
4. Are there any applicable national fees or forms we should be aware of?
5. If applicable, could you please provide access to or a link for your registration/notification portal?
Product Summary:
* Name: VDI UHF-ECG
* Intended use: Ultra-high frequency electrocardiogram analysis for advanced cardiac signal processing
* Notified Body: 1383
We are happy to provide any further documentation or clarification you may require.
Thank you for your guidance and support.
Sincerely,
Marek Šturek
Marek Šturek | MS, MBA, LSSMBB
Head of Quality Assurance & Project Management
www.vdimaging.com <http://www.vdimaging.com/> | +420 604-645-922