Conformity Assessment according to the IVDR

We are Authorized Body No. SKTC-113 and Notified Body No. 2265 for:

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices as amended.

For a better overview of how the conformity assessment process of in vitro diagnostic medical devices takes place, you can consult the following chart: Flowchart of MD Conformity Assessment in NB2265.

In case of interest in our services in the field of Conformity Assessment of medical devices, please, send filled document "Questions for Quoting", "List of products" and other requested document on e-mail address stated in the form. Forms are evaluated in the Certification Board once a month. We will inform you about the result of the evaluation.

If you are interested in our services, please, contact our office.

Confirmation that we are authorised to perform the Conformity Assessment of In Vitro Diagnostic Medical Devices in accordance with the mentioned directive and the scope of activities can be found on official NANDO website.

One of the most important aspect of our work is impartial and objective assessment of evidence. Therefore we decided to establish and keep Impartiality Policy in Product Certification which represents our commitment and intention.

Download files

Questions for Quoting

DOC 46,30 kB

Minimal Requirements for Content of the Technical Files of MD according to the IVDR

PDF 72,88 kB

List of products to Questions for Quoting

XLS 76,42 kB

General terms and conditions of 3EC International a.s. (GTC)

PDF 388,89 kB

Policy of CE marking use

PDF 40,77 kB

Pricelist for conformitty assesment of IVD MD