Product certification IVD MD

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

Directive of the European Parliament and of the Council 98/79/EC on in vitro diagnostic medical devices as amended.

For a better overview of how the product certification takes place, you can consult the following chart: Flowchart of Conformity Assessment of IVD MD in NB2265.

In case of interest in our services in the field of Product Certification, please, send filled document "Questions for Quoting" on our e-mail address info@3ec.sk

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 47,68 kB

Rules and conditions for affixing CE Mark

PDF 54,35 kB

General terms and conditions for MD & IVD MD

PDF 296,27 kB

Blue Guide

PDF 2,25 MB