Product certification

We are Authorized Body No. SKTC-113 for the Regulation of the Government of the Slovak Republic No. 569/2001 Coll. as amended and Regulation of the Government of the Slovak Republic No. 582/2008 Coll. as amended by Regulation of the Government of the Slovak Republic No. 215/2013 Coll. and Notified Body No. 2265 for:

Council Directive 93/42/EEC concerning medical devices as amended,
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: Product certification.

In case of interest in our services in the field of Product Certification, please, send filled document "Questions for Quoting" via contact form.

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

Confirmation that we are authorised to perform the Conformity Assessment of Medical Devices in accordance with the mentioned directives 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 178,50 kB

Minimum requirements for Technical Files

PDF 32,86 kB

General terms and conditions for MD & IVD MD

PDF 301,18 kB

Rules and conditions for affixing CE Mark

PDF 60,88 kB

Blue Guide

PDF 3,55 MB

EU Commission Recommendation 2013/473/EU on Unannounced Audits