Küsimused

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. 1. Is national registration or notification required prior to placing a CE-marked Class IIa device on your market?

2. 2. What documentation is required (e.g., CE Certificate, Declaration of Conformity, GMDN codes, labels, IFU)?

3. 3. What language requirements apply for labeling, Instructions for Use (IFU), and submissions?

4. 4. Are there any applicable national fees or forms we should be aware of?

5. 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