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 independence, impartiality and objective assessment of evidence. Therefore NB2265 Top Management issued Declaration of Commitment of Impartiality of NB2265 Top Management which represents our commitment and best intention.

In case you would like to express your dissatisfaction with services provided by the notified body, please, kindly send your objections to our address: 3EC International a.s., Hraničná 18, 821 05 Bratislava, Slovakia.

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

Form for announcement of IVD MD changes

DOC 46,38 kB

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

PDF 388,89 kB

Policy of CE marking use